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Whats the Protocol for Starting Birth Control Pills Again

  • Periodical List
  • Cochrane Database Syst Rev
  • PMC6956679

Cochrane Database Syst Rev. 2012 Dec; 2012(12): CD006260.

Immediate start of hormonal contraceptives for contraception

Monitoring Editor: Laureen Thou Lopez, corresponding author Sara J Newmann, David A Grimes, Kavita Nanda, Kenneth F Schulz, and Cochrane Fertility Regulation Group

FHI 360, Clinical Sciences, P.O. Box 13950, Research Triangle ParkUSA, 27709

Academy of California, San Francisco General Hospital, Obstetrics and Gynecology and Reproductive Sciences, 1001 Potrero Avenue Ward 6D, San FranciscoUSA, CA 94110

University of North Carolina, School of Medicine, Obstetrics and Gynecology, CB#7570, Chapel HillUSA, 27599‐7570

FHI, Clinical Sciences, P.O. Box 13950, Enquiry Triangle ParkUSA, 27709

FHI 360 and UNC School of Medicine, Quantitative Sciences, P.O. Box 13950, Research Triangle ParkUSA, NC 27709

Abstract

Background

Wellness care providers often tell women to look until the side by side period to begin hormonal contraception. The intent is to avoid contraceptive use during an undetected pregnancy. An alternative is to beginning hormonal contraception immediately with dorsum‐upwards birth control for the first seven days. Immediate initiation was introduced with combined oral contraceptives (COCs), and has expanded to other hormonal contraceptives. At the time of the initial review, how immediate start compared to conventional menses‐dependent start was unclear regarding effectiveness, continuation, and acceptability. The immediate‐showtime approach may improve women's access to, and continuation of, hormonal contraception.

Objectives

This review examined randomized controlled trials (RCTs) of immediate‐start hormonal contraception for differences in effectiveness, continuation, and acceptability.

Search methods

In August 2012, we searched MEDLINE, Fundamental, POPLINE, LILACS, ClinicalTrials.gov, and ICTRP for trials of immediate‐start hormonal contraceptives. We contacted researchers to detect other studies. Earlier searches too included EMBASE.

Option criteria

We included RCTs that compared immediate beginning to conventional first of hormonal contraception. Also included were trials that compared immediate outset of dissimilar hormonal contraceptive methods with each other.

Data collection and analysis

Data were bathetic by two authors and entered into RevMan. The Peto odds ratio (OR) with 95% confidence interval (CI) was calculated.

Main results

Five studies were included. No new eligible studies accept been found since the review was initially conducted. Method discontinuation was like betwixt groups in all trials. Bleeding patterns and side effects were similar in trials that compared immediate with conventional showtime. In a written report of depot medroxyprogesterone acetate (DMPA), immediate start of DMPA showed fewer pregnancies than a 'span' method before DMPA (OR 0.36; 95% CI 0.sixteen to 0.84). Further, more women in the immediate‐DMPA group were very satisfied versus those with a 'bridge' method (OR i.99; 95% CI 1.05 to 3.77). A trial of two firsthand‐start methods showed the vaginal ring group had less prolonged haemorrhage (OR 0.42; 95% CI 0.xx to 0.89) and less frequent bleeding (OR 0.23; 95% CI 0.05 to ane.03) than COC users. The band group besides reported fewer side effects. Also, more immediate band users were very satisfied than firsthand COC users (OR 2.88; 95% CI 1.59 to 5.22).

Authors' conclusions

We found limited evidence that immediate kickoff of hormonal contraception reduces unintended pregnancies or increases method continuation. All the same, the pregnancy rate was lower with firsthand offset of DMPA versus another method. Some differences were associated with contraceptive blazon rather than initiation method, i.east., immediate ring versus immediate COC. More studies are needed of immediate versus conventional start of the same hormonal contraceptive.

Evidently language summary

Firsthand start of hormonal birth control

Health care providers oft tell women to look until their next menstrual cycle to begin nascency control pills. The main reason is to avoid using birth command during an undetected pregnancy. Another method involves starting the pills right away ('firsthand showtime' or 'quick start'). Another birth control method should be used as back‐upwardly for the commencement seven days. Unclear issues were whether quick start of hormonal birth control works too equally the usual start and whether women similar it. The quick start method might improve women's use of hormonal birth command.

In Baronial 2012, did figurer searches for randomized controlled trials of the quick‐start method for pills and other hormonal birth control. Nosotros contacted researchers to detect other studies. We included trials that compared quick start to the usual start of birth control. Too included were studies that compared quick start of different types of hormonal birth control with each other. Birth command methods could have the hormones estrogen and progestin (combined hormonal birth command) or only the progestin.

Five studies were included. In a study of 'depo,' which is given equally a shot, fewer women with quick outset of depo became pregnant than those who used another method for 21 days before depo. In this review, the numbers of women who stopped using their birth control method early were similar between groups in all trials. In the depo trial, more women with quick start of depo were very satisfied.

A trial of two quick‐start methods showed women with the vaginal ring had less long‐term bleeding and less frequent bleeding than those with pills. For six side effects, including changes in breasts, mood, and nausea, quick starting time of the ring showed fewer problems than quick offset of pills. For satisfaction in that trial, more women in the ring group were very satisfied with their method of nascency control.

We institute petty evidence that quick commencement leads to fewer pregnancies or fewer women stopping early. Notwithstanding, fewer women on quick showtime of depo became pregnant than the women who started with some other method. Other differences were between types of birth command rather than start times. Women using the vaginal ring had fewer bug than women using birth control pills. More than studies are needed comparing quick start versus usual start of the aforementioned hormonal nascence control method.

Background

The optimal time to starting time hormonal contraception remains unknown. Worldwide, about 104 million women use contraceptive pills and nearly 45 meg use injectable contraceptives or implants (UNDP 2011). Traditionally, women have been instructed to starting time combined oral contraceptives (COCs) in relation to their menstrual wheel: either on day one or within the first five to seven days of their menses (Kubba 1993) or on the Lord's day afterwards their menses began (Williams‐Deane 1992). Many health care providers and pharmaceutical companies suggest multiple options for starting oral contraceptives (OCs), which are timed in relation to menses (Williams‐Deane 1992). These multiple options can create confusion regarding when to start the pill. Furthermore, menstruation requirements for initiation of contraception impede access to contraception for non‐menstruating women, i.eastward., those who nowadays for family planning services between two bleeding periods or during postpartum amenorrhea. Prospective studies in four developing countries showed service denial rates ranging from v% to 47% among new family planning clients if they were not menstruating at the time of their visit (Stanback 2005; Stanback 2007). But 16% of providers in Kenya felt safe in giving women OCs to starting time taking later (Stanback 2003). In Ghana and Senegal, less than five% of providers reported they gave pills to non‐menstruating women for later employ at the onset of menses (Stanback 2003).

The recommendation for women to await until the next menses to begin hormonal contraception is intended to avoid contraceptive utilize during an undetected pregnancy. During this filibuster in contraceptive initiation, unintended pregnancies can occur, women may choose a less effective method or forget instruction (FSRH 2010), and fears of side effects increment (Westhoff 2002). This medically‐imposed delay in starting contraception may increment the cost of family planning due to more repeat or return dispensary visits. Worldwide, unintended pregnancies are associated with preventable morbidity and mortality. In contrast, reviews of epidemiological data and prospective studies have indicated that exogenous hormones during pregnancy did not increase risk of developing abnormalities in non‐genital organs (Wilson 1981); oral contraceptives were non associated with congenital malformations (Bracken 1990).

An alternative is to first hormonal contraceptives immediately with back‐upwards birth control for the first 7 days (Lara‐Torre 2004). This 'firsthand‐start' or 'quick‐start' method may improve initiation and continuation of hormonal contraceptives, amongst both adolescents and adults, compared to conventional start methods (Lara‐Torre 2002; Westhoff 2002). Immediate start of birth control was introduced with combined oral contraceptives, which have both progestin and estrogen, and has been expanded to other hormonal contraceptives (WHO 2004; Murthy 2005; Westhoff 2005). When nosotros conducted this initial review, how immediate beginning of hormonal contraception compared to conventional menses‐dependent get-go was unclear regarding effectiveness, continuation, and acceptability. The practice of 'quick get-go' for hormonal contraceptives has since become accepted past professional organizations (FSRH 2010; ARHP 2011).

Objectives

This review examined randomized controlled trials (RCTs) of firsthand‐starting time hormonal contraception for differences in effectiveness, continuation, and acceptability.

Methods

Criteria for considering studies for this review

Types of studies

We included randomized controlled trials (RCTs) in any language that compared immediate start of hormonal contraceptives to conventional first. We also included RCTs that compared firsthand commencement of dissimilar hormonal contraceptive methods with each other. Handling duration had to be at to the lowest degree iii cycles or 84 days.

Types of participants

All women with information in the eligible trials were included in this review.

Types of interventions

We included any contraception initiation method: firsthand beginning and start in relation to timing of menses. Nosotros also included any type of hormonal contraception: oral, intramuscular, transdermal, and transvaginal.

Types of result measures

Contraceptive effectiveness, continuation rates, bleeding patterns, acceptability, and side furnishings.

Search methods for identification of studies

Electronic searches

In August 2012, nosotros searched the computerized databases MEDLINE, Cochrane Central Register of Controlled Trials (Cardinal), POPLINE, and LILACS for studies of immediate‐start hormonal contraceptives. We too searched for trials via ClinicalTrials.gov and the search portal of the International Clinical Trials Registry Platform (ICTRP). The search strategy is shown in Appendix ane. The before strategy, which also included EMBASE, can be found in Appendix 2.

Searching other resources

We examined reference lists of relevant articles. We also wrote to known investigators for information about other published or unpublished trials not discovered in our search.

Data collection and analysis

Pick of studies

Nosotros assessed for inclusion the titles and abstracts identified during the literature searches.

Data extraction and management

One author reviewed the search results and identified reports for inclusion or exclusion. Some other author also examined the reports identified for appropriate categorization. Similarly, one author bathetic the data and entered the information into RevMan. Another writer conducted a second information abstraction and verified correct data entry. Whatsoever discrepancies were resolved by discussion.

Assessment of risk of bias in included studies

Studies were examined for methodological quality, according to the principles recommended in Higgins 2005. Factors considered were study design, randomization method, allocation concealment, blinding, and losses to follow‐up and early discontinuation. Adequate methods for allocation darkening include a centralized telephone system and the use of sequentially‐numbered, opaque, sealed envelopes (Schulz 2002a). Pharmacy distribution of pill bottles is another good method. Excluding randomized persons is non consistent with an intent‐to‐treat analysis and can bias the results (Schulz 2002b). High losses to follow‐up threaten validity (Strauss 2005). Limitations in blueprint are presented in Risk of bias in included studies and were considered when interpreting the results.

Data synthesis

For dichotomous outcomes, the Peto odds ratio (OR) with 95% Confidence Interval (CI) was calculated. Examples are the proportion of women who became meaning or who discontinued contraception early. The Peto OR is useful when handling effects are small and when events are non very common (Higgins 2005). This approach performs well under many circumstances, except when the study arm sizes are severely unbalanced, which rarely occurs in RCTs (Deeks 2001). A fixed‐upshot model does non crave the assumption of normal distribution for the effects (Deeks 2001; Higgins 2005). Stock-still upshot and random effects will give the same result if no heterogeneity exists, which is also the case if a comparison includes a single study. In that location is no consensus regarding the apply of either model. We had planned to test for statistical heterogeneity. Even so, nosotros did non combine data from any studies in meta‐analysis due to differences in interventions.

For assay, nosotros used intent to treat or per protocol as information were bachelor in the reports. Outcome information are described in Characteristics of included studies, forth with any exceptions due to reporting. Exclusions past the trial authors are described in the Risk of bias tables.

Results

Description of studies

Results of the search

In 2012, the searches produced 170 unduplicated references. This included 147 citations from the electronic databases and 23 from other sources (ClinicialTrials.gov, ICTRP, and communication from a researcher). We did non identify any new eligible trials. When the review was updated in 2010, nosotros did not discover whatever new trials to include either.

Included studies

Five randomized controlled trials met the eligibility criteria. All trials were conducted in the USA and published from 2003 to 2007. Four trials were related, having been conducted by members of the same enquiry grouping (Westhoff 2003; Westhoff 2005; Rickert 2007; Westhoff 2007).

The trials included a full of 2427 women. Sample sizes ranged from 60 to 1720 with an average of 485. Sample sizes were 113 in Westhoff 2003, 60 in the pilot report of Murthy 2005, 201 in Westhoff 2005, 333 for Rickert 2007, and 1720 in Westhoff 2007. All studies reported an a priori sample size determination: three focused on discontinuation rates (Murthy 2005; Rickert 2007; Westhoff 2007) and ii were based on bleeding and spotting days (Westhoff 2003; Westhoff 2005).

Treatment elapsing was three cycles or 84 to xc days in Westhoff 2003, Murthy 2005, and Westhoff 2005 and six months in Rickert 2007 and Westhoff 2007.

The comparisons differed across trials. Immediate beginning refers to initiating contraception during the first visit. Conventional showtime of contraception included instruction to start during the adjacent menstruum. Only Rickert 2007 excluded women who were currently menstruating. Ii studies compared immediate versus conventional start of OCs; Westhoff 2003 used a COC (norethindrone 1 mg plus ethinyl estradiol (EE) 35 µg), while in Westhoff 2007 the type of OC depended on the clinician'south preference. Murthy 2005 examined firsthand versus conventional kickoff of the contraceptive patch (containing norelgestromin half dozen mg plus EE 75 µg (Ortho‐McNeil 2007)). Rickert 2007 examined immediate injection of depot medroxyprogesterone acetate (DMPA) versus a contraceptive 'bridge' to DMPA. 'Bridge' participants could choose pills, patch, or band earlier DMPA and were given a 21‐day supply; their first DMPA injection was administered 21 to 28 days later. The trial of Westhoff 2005 differed in that immediate employ of the vaginal contraceptive ring (daily release: etonogestrel 120 µg plus EE fifteen µg) was compared with firsthand COC (norgestimate (NGM) 180/215/250 µg plus EE thirty µg).

In four trials, participants in both groups were instructed to apply condoms as a backup (or abstain) for the first vii days or until they started their contraceptive method (Westhoff 2003; Westhoff 2005; Rickert 2007; Westhoff 2007). Women in Westhoff 2005 were also given emergency contraception. In Murthy 2005, reportedly just the firsthand‐start group was instructed to use a dorsum‐upwardly method like condoms for seven days; however, all participants were given a prescription for emergency contraception.

The outcomes included pregnancy information for all just Murthy 2005, discontinuation of method for four trials, bleeding or wheel control data for all but Rickert 2007, and satisfaction with method in three trials (Westhoff 2003; Westhoff 2005; Rickert 2007). Data on side effects or adverse events were varied. For examples, Murthy 2005 but reported on nausea, and Westhoff 2007 reported just the serious adverse events. The Schafer 2006 report from the Westhoff 2005 trial assessed the women for ten potential side effects; participants could report no change, adept change, or bad change.

Excluded studies

Two older trials were brought to our attending by a colleague. Earlier, we determined that Bednarek 2008 was not relevant based on the abstract. We have now added it to 'excluded studies' with the reason that the outcome measure out of bleeding was not relevant. Martin 1998 was also identified; it was not found in before searches because the championship and abstract did not bespeak quick or immediate start. We added it to 'excluded studies' because it was not a contraception trial.

Also excluded was a trial listed before equally ongoing (Karjane 2011). Information technology has since been terminated due to recruitment problems. Lastly, nosotros examined the total text of Madden 2011 and institute that it was non an RCT.

Risk of bias in included studies

Resource allotment

The quality of reporting was uneven for some design bug. Randomization in four trials was described equally generated with random numbers tabular array or random numbers generator. Ane trial did not provide data on how the randomization sequence was generated and did not specify if the resource allotment was concealed before assignment (Murthy 2005). Two studies had adequate resource allotment darkening with sequentially‐numbered, opaque, sealed envelopes (Westhoff 2003; Westhoff 2005). 2 trials had some concealment, as they reported using sequential sealed envelopes (Rickert 2007) or numbered opaque envelopes (Westhoff 2007).

Blinding

All appeared to be open‐characterization, about likely due to the differences in the interventions. However, Westhoff 2003 noted that the person who abstracted the diary information was blinded to group consignment.

Incomplete effect data

Three studies appeared to use intent‐to‐treat assay, in which all the women who were randomized and had follow‐up data were included in the analysis (Murthy 2005; Westhoff 2005; Rickert 2007). Two studies excluded women from the study who had been randomized simply then were found to have been ineligible due to pregnancy (Westhoff 2003; Westhoff 2007).

Losses to follow‐up also varied. Westhoff 2003 and Murthy 2005 had losses around two%, while Westhoff 2005 lost thirteen% and Westhoff 2007 lost about 16%. The DMPA written report of Rickert 2007 had high losses of 32% for each group. High losses to follow‐upward threaten validity (Strauss 2005), and many methodologists would question whether Rickert 2007 should still be considered 'randomized' given the losses.

Furnishings of interventions

The trials examined here included several different types of comparisons. 3 trials compared immediate versus conventional kickoff of the same contraceptive method: a specific COC (Westhoff 2003), various types of OCs (Westhoff 2007), and the contraceptive patch (Murthy 2005). Rickert 2007 compared immediate start of DMPA to a 'bridge' to DMPA (using pills, transdermal patch, or vaginal band for 21 days before the first DMPA injection). Westhoff 2005 compared two immediate‐start methods (vaginal ring versus COC). Most differences were establish between types of contraceptives rather than between immediate and conventional initiation. No trials were combined in meta‐analysis due to the differences in interventions.

Effectiveness

Four studies reported the proportions of women who became significant during the written report. In Rickert 2007, the immediate DMPA grouping was less probable to become pregnant than the span group (OR 0.36; 95% CI 0.sixteen to 0.84). The groups were like in contraceptive effectiveness in Westhoff 2003 and Westhoff 2007, which compared immediate to conventional start of OCs. When the pregnancies estimated to have occurred prior to enrollment were included in the analysis, the groups were still similar in Westhoff 2003 and Westhoff 2007. A secondary publication of Westhoff 2007 included analysis of the subset younger than eighteen years. The firsthand start and conventional kickoff groups in that subset were too similar for pregnancy.

Westhoff 2005 compared ii immediate‐offset methods (band and COC); no divergence in pregnancy rates was evident in that study, either.

Contraceptive method discontinuation

Method discontinuation was similar across groups in the studies with such data. Murthy 2005 compared immediate to conventional start of the patch, Rickert 2007 examined firsthand DMPA and a bridge to DMPA, and Westhoff 2003 studied immediate versus conventional start of the aforementioned COC. For method discontinuation, Westhoff 2007 provided percentages for the groups combined; the immediate and conventional outset groups were reportedly similar. Westhoff 2007 included various OCs, co-ordinate to the clinician'southward preference.

No difference in discontinuation was noted in the Schafer 2006 report from Westhoff 2005, which compared two immediate‐start methods (band versus COC).

Wheel control

Four trials reported bleeding information. The study groups had like bleeding profiles in three trials that compared immediate with conventional start: Murthy 2005 (patch); Westhoff 2003 (same COC); and Westhoff 2007 (various OCs).

In Westhoff 2005, which compared two immediate start methods, prolonged bleeding (bleeding or spotting episode lasting at least 10 days) was lower for the grouping with the band compared to those with COCs (OR 0.42; 95% CI 0.20 to 0.89). Frequent haemorrhage, divers as more than than four episodes of bleeding or spotting, also differed in favor of the vaginal ring group (OR 0.23; 95% CI 0.05 to 1.03) (Westhoff 2005).

Agin events

Information on side effects varied.

  • Murthy 2005 reported on nausea, for which the firsthand and conventional start of the patch groups were similar.

  • Rickert 2007 reported no adverse events with either the immediate starting time of DMPA or the group with a bridge to DMPA.

  • Westhoff 2007 merely reported serious adverse events (SAEs), for which the firsthand and conventional start groups were similar; diverse OCs were included. Examples of SAEs were cholecystectomy, pyelonephritis, and pelvic inflammatory disease (Westhoff 2007); the authors did non specify whether any SAEs were considered related to the intervention.

For the Westhoff 2005 trial, the after written report of Schafer 2006 showed that 6 of 10 side furnishings were less common for the immediate use of the vaginal ring versus immediate start of COCs. The vaginal ring group less frequently reported a "bad change" for weight (OR 0.42; 95% CI 0.21 to 0.87), haemorrhage (OR 0.28; 95% CI 0.14 to 0.55), breasts (OR 0.36; 95% CI 0.eighteen to 0.73), mood (OR 0.36; 95% CI 0.19 to 0.69), appetite (OR 0.44; 95% CI 0.21 to 0.95), or nausea (OR 0.xxx; 95% CI 0.14 to 0.62) (Westhoff 2005).

Satisfaction and futurity use

3 trials provided information on method satisfaction (Westhoff 2003; Westhoff 2005; Rickert 2007). In Rickert 2007, women in the immediate starting time of DMPA group were more than probable to be very satisfied with their method at six months compared to those with use of a bridge method (OR one.99; 95% CI 1.05 to 3.77). Westhoff 2003 showed no differences between the immediate and conventional start of the COC.

In Westhoff 2005, which studied two immediate‐start methods, more women with the vaginal ring reported being very satisfied with their method compared to the grouping with COCs (OR ii.88; 95% CI 1.59 to 5.22). Similarly, more than women with firsthand start of the vaginal ring planned to use the method after the study (OR 2.51; 95% CI ane.32 to 4.77).

Discussion

Ane of the purposes of immediate start of contraception is to meliorate initiation and continuation rates and thus decrease unintended pregnancies. In this review, pregnancy differed in ane written report that compared immediate offset of DMPA to using a bridge to DMPA. Compared to many other contraceptive methods, DMPA is long‐acting and less user‐dependent. While the 'immediate‐DMPA' group had proportionately fewer pregnancies, losses were high in that trial. Some of the studies were underpowered to detect differences in pregnancies. Yet, method discontinuation was similar between study groups in this review.

Cycle control, from bleeding diaries, only differed in a report of two immediate methods. The vaginal ring group had fewer bleeding problems than the COC group (Westhoff 2005). The same trial solicited side effect information and showed differences between the vaginal ring and COC groups. Westhoff 2005 did non provide criteria or details for reporting side effects. Other trials showed the comparison groups to be similar for adverse events. The trials did not have consistent recording or reporting of side furnishings, which complicates interpretation. Furthermore, side furnishings may dissipate over time and these trials were relatively short‐term.

For satisfaction, two trials showed some differences. In the DMPA trial, the group with immediate use of DMPA was more than satisfied than those with a bridge method first. In the trial of 2 immediate methods, the vaginal ring group was more satisfied than the COC group. However, these studies were only three or half dozen months in duration and satisfaction may vary over time.

All of the trials were relatively contempo, yet they did not follow Consort guidelines for reporting (Moher 2001; Consort 2010). Design details were sometimes lacking. In addition, Espoused recommends the reporting of outcome data in accented numbers, rather than percentages. For outcomes reported as means, a measure of variation is needed to translate the results. Two trials did not follow those guidelines, which prevented the inclusion of some data in the review.

This review was limited due to having only five trials and to dandy variation in the comparisons. 1 study compared two immediate‐start methods. Of the four trials comparing immediate starting time with conventional start, one focused on the skin patch and another on DMPA (with or without a span method). The remaining two trials studied OCs, only ane examined the same COC with unlike initiation methods, while the other left the OC selection to clinicians. In addition, no study was adequately powered for contraceptive effectiveness (pregnancy), a primary upshot for this review. Trials were generally powered to detect differences in continuation or bleeding patterns.

Authors' conclusions

Implications for practice

We institute lilliputian evidence that immediate beginning of hormonal contraceptives reduces unintended pregnancies or increases continuation. Bleeding patterns and side furnishings were like in trials that compared immediate start with conventional start. Immediate start is one of several acceptable options for starting COCs although more data are needed. One trial showed a lower risk of pregnancy with immediate kickoff of DMPA versus bridging to DMPA with another method. High losses in that trial could have biased the results.

Implications for research

More trials are needed of immediate versus conventional get-go of the same (rather than a different) hormonal contraceptive method. The primary assay should exist washed by intent‐to‐treat; that is, all enrolled participants should exist included. Consequent recording and reporting of bleeding and other side effects would aid interpretation beyond trials. Improved follow‐up is critical to estimation of trial results, as loftier losses threaten validity. Sackett suggested that trials with greater than 20% loss to follow‐upward after randomization should non be considered valid (Strauss 2005); Schulz suggested that the frequency of loss to follow‐up should not exceed the frequency of the outcome event, due east.g., pregnancy (Schulz 2002b).

In full general, we endorse planning for adequate power (Schulz 2005). However, if the scientific world insisted exclusively on big trials, many questions in medicine would languish unanswered. 'Underpowered' trials can be acceptable because they could be combined in a meta‐analysis. Our proposition has 3 caveats. First, the trial should be methodologically strong, thus eliminating bias. If designed and implemented properly, the trial would yield an unbiased estimate of effect even if it has low ability (and precision). The results could then be combined with similar unbiased trials in a meta‐analysis. Second, to avert misinterpretation, authors should written report their methods and results properly. If trial results were reported using interval interpretation, the broad confidence intervals effectually the estimated treatment consequence would depict the depression power. Third, low‐powered trials should exist published regardless of their results so they can be used in meta‐analysis.

Finally, authors should adhere to the internationally accepted guidelines for reporting randomized controlled trials (Espoused 2010).

What's new

Date Issue Description
29 October 2012 New commendation required just conclusions accept not inverse No new trials included. Excluded 3 published trials (Bednarek 2008; Madden 2011; Martin 1998) and one that was discontinued (Karjane 2011).
26 Oct 2012 Amended Added to Types of studies: Treatment duration had to be at least 3 cycles or 84 days.
12 September 2012 New search has been performed Searches updated

History

Protocol first published: Issue 4, 2006
Review outset published: Outcome 2, 2008

Date Event Description
17 September 2010 New search has been performed We updated the searches and added searches of ClinicalTrials.gov and ICTRP. A secondary report of Westhoff 2007 was located, simply no new trials were establish.
15 April 2008 Amended Converted to new review format.
fifteen January 2008 New citation required and conclusions have changed Substantive amendment

Acknowledgements

From FHI 360: Carol Manion assisted with literature searches (2007 and 2010); Laurie Stockton reviewed studies for eligibility and searched for additional study information (2012); John Stanback helped update the Groundwork section (2012).

Appendices

Appendix 1. Search strategy, 2012

MEDLINE via PubMed (01 January 2010 to 12 Sep 2012)

contraceptive agents, female OR (steroid* AND contracept*) OR orthoevra OR "ortho evra" OR "norelgestromin" OR (contraceptive devices, female and ring) OR NuvaRing OR cyclofem OR lunelle OR mesigyna OR cycloprovera OR (medroxyprogesterone 17‐acetate AND (contracept* OR inject* OR depo OR depot)) OR depot medroxyprogesterone OR depo medroxyprogesterone OR depotmedroxyprogesterone OR depomedroxyprogesterone OR dmpa OR "cyberspace en" OR norethisterone enantate OR norplant OR uniplant OR jadelle OR implanon OR ((levonorgestrel OR etonogestrel) AND implant) OR (levonorgestrel AND intrauterine devices) OR mirena OR ((progestational hormones OR progestin) AND (contracept* AND (oral OR pill* OR tablet*))) AND (((time factors OR firsthand OR timing) AND (start* OR brainstorm* OR initiat*)) OR "quick start" OR starting day OR drug administration schedule OR (observed AND start) OR "Sunday start") AND Clinical Trial[ptyp]

Primal (2010 to 28 Aug 2012)

contracept* in Title, Abstract or Keywords
AND initiat* OR first* OR brainstorm* OR quick start OR drug assistants schedule in Title, Abstract or Keywords
NOT IVF OR cancer OR PCOS OR HIV OR emergency OR migraine in Tape Title

POPLINE (2010 to 29 Aug 2012)

Global: (contraceptive agents, female person) OR (contraceptive methods) OR (contraceptive implants)
AND (start AND (quick OR firsthand OR time OR timing)) OR "quick start"
Filter by keywords: Research report

LILACS (2010 to 12 Sep 2012)

contraceptive agents, female or agentes anticonceptivos femeninos or anticoncepcionais femeninos or contraceptives, oral or anticonceptivos orales or anticoncepcionais orais [Words]
AND start or initiator or inciador or begin or beginning or comienzo or incio or initiation or quick commencement or starting day or drug administration schedule [Words]

ClinicalTrials.gov (01 Jan 2010 to 28 Aug 2012)

Search terms: (((time factors OR immediate OR timing) AND (commencement* OR begin* OR initiat*)) OR "quick get-go" OR starting day OR drug assistants schedule)
Status: Not (in vitro OR IVF OR cataract)
Intervention: contraceptive OR contraception
Written report blazon: interventional studies
Gender: studies with female participants

ICTRP (01 Jan 2010 to 29 Aug 2012)

Title: firsthand OR timing OR offset OR starting OR begin OR initiate OR initiation OR quick
Condition: contraceptive OR contraception

Appendix 2. Search strategy, 2008 and 2010

MEDLINE via PubMed (through 28 Aug 2010)

(contraceptive agents, female person OR (steroid* AND contracept*) OR orthoevra OR "ortho evra" OR "norelgestromin" OR (contraceptive devices, female and ring) OR NuvaRing OR cyclofem OR lunelle OR mesigyna OR cycloprovera OR (medroxyprogesterone 17‐acetate AND (contracept* OR inject* OR depo OR depot)) OR depot medroxyprogesterone OR depo medroxyprogesterone OR depotmedroxyprogesterone OR depomedroxyprogesterone OR dmpa OR "cyberspace en" OR norethisterone enantate OR norplant OR uniplant OR jadelle OR implanon OR ((levonorgestrel OR etonogestrel) AND implant) OR (levonorgestrel AND intrauterine devices) OR mirena OR ((progestational hormones OR progestin) AND contracept* AND (oral OR pill* OR tablet*))) AND (((time factors OR immediate OR timing) AND (start* OR begin* OR initiat*)) OR "quick start" OR starting twenty-four hour period OR drug administration schedule)

CENTRAL (through 28 Aug 2010)

contracept* and (initiat* or start* or brainstorm* or quick start or drug administration schedule) in Title, Abstract, or Keywords

POPLINE (through 30 Aug 2010)

(Contraceptive Agents Female/depo provera/dmpa/medroxyprogesterone/(steroid* & contracept*) /orthoevra/ortho evra /norelgestromin/(contraceptive devices, female and band)/ NuvaRing /cyclofem /lunelle/ mesigyna/ cycloprovera/ (medroxyprogesterone 17‐acetate & (contracept* /inject*/depo/depot))/ depot medroxyprogesterone/ depo medroxyprogesterone/ depot medroxyprogesterone/depo medroxyprogesterone/dmpa/ net en/ norethisterone‐enantate/norplant/uniplant/jadelle/implanon/((levonorgestrel/ etonogestrel) & implant)/(levonorgestrel & intrauterine devices)/mirena /((progestational hormones/progestin) & contracept* & (oral/pill*/tablet*))) & (start & (quick/immediate/time/timing))/"quick offset"

LILACS (01 Sep 2010)

contraceptive agents, female or agentes anticonceptivos femeninos or anticoncepcionais femeninos or contraceptives, oral or anticonceptivos orales or anticoncepcionais orais [Words] and start or initiator or inciador or begin or beginning or comienzo or incio or initiation or quick start or starting day or drug administation schedule [Words]

EMBASE (through 03 Sep 2010)

CONTRACEPTIVE AGENT? OR STEROID?(Westward)CONTRACEPT?
AND DRUG ADMINISTRATION AND (QUICK(W)START OR First? OR INITIAT?OR Brainstorm?).

ClinicalTrials.gov (through 30 Aug 2010)

Search terms: (((time factors OR immediate OR timing) AND (showtime* OR begin* OR initiat*)) OR "quick start" OR starting day OR drug administration schedule)
Intervention: contraceptive OR contraception
Study type: interventional studies
Gender: studies with female participants

ICTRP (through 31 Aug 2010)

Championship: firsthand OR timing OR starting time OR starting OR begin OR initiate OR initiation OR quick
Condition: contraceptive OR contraception

Notes

New search for studies and content updated (no change to conclusions)

Data and analyses

i

Immediate versus conventional commencement of COC (norethindrone 1 mg + EE 35 µg)

Outcome or subgroup title No. of studies No. of participants Statistical method Outcome size
ane Pregnancy per woman 1 111 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.67 [0.04, 11.47]
2 Discontinued OCs during 90‐day period 1 111 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.48 [0.10, 2.28]
three Frequent haemorrhage (> 4 episodes of bleeding or spotting) 1 104 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.71 [0.28, one.79]
iv Irregular bleeding (bleeding‐free interval > 17 days) 1 104 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.82 [0.34, ane.99]
5 Prolonged bleeding (bleeding or spotting episode lasting >= ten days) ane 104 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.89 [0.35, 2.24]
6 Amenorrhea (no bleeding) one 104 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]
7 Overall satisfaction with OCs 1 104 Peto Odds Ratio (Peto, Stock-still, 95% CI) 0.76 [0.14, four.10]
8 Would make the aforementioned decision to start OCs one 104 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.62 [0.13, 2.94]

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Comparison 1 Immediate versus conventional kickoff of COC (norethindrone ane mg + EE 35 µg), Outcome ane Pregnancy per adult female.

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Comparison i Firsthand versus conventional start of COC (norethindrone 1 mg + EE 35 µg), Outcome two Discontinued OCs during ninety‐twenty-four hours menstruation.

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Comparison i Immediate versus conventional start of COC (norethindrone one mg + EE 35 µg), Outcome 3 Frequent bleeding (> 4 episodes of bleeding or spotting).

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Comparison one Firsthand versus conventional beginning of COC (norethindrone 1 mg + EE 35 µg), Outcome four Irregular haemorrhage (bleeding‐free interval > 17 days).

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Comparison i Immediate versus conventional outset of COC (norethindrone 1 mg + EE 35 µg), Outcome 5 Prolonged bleeding (haemorrhage or spotting episode lasting >= 10 days).

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Comparison i Immediate versus conventional kickoff of COC (norethindrone 1 mg + EE 35 µg), Outcome 6 Amenorrhea (no bleeding).

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Comparison 1 Immediate versus conventional start of COC (norethindrone one mg + EE 35 µg), Result 7 Overall satisfaction with OCs.

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Comparing 1 Immediate versus conventional start of COC (norethindrone 1 mg + EE 35 µg), Outcome 8 Would make the same decision to commencement OCs.

2

Firsthand versus conventional start of OCs

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Comparison 2 Firsthand versus conventional start of OCs, Outcome ane Pregnancy per woman.

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Comparison ii Immediate versus conventional start of OCs, Upshot two Pregnancy per young woman (<18 years erstwhile).

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Comparison 2 Immediate versus conventional start of OCs, Effect 3 Serious agin events.

3

Firsthand versus conventional kickoff of contraceptive patch (norelgestromin 150 µg + EE 20 µg)

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Comparison 3 Immediate versus conventional outset of contraceptive patch (norelgestromin 150 µg + EE 20 µg), Event ane Discontinuation of patch by cycle 3.

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Comparison 3 Immediate versus conventional start of contraceptive patch (norelgestromin 150 µg + EE 20 µg), Outcome two Breakthrough bleeding.

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Comparing 3 Immediate versus conventional start of contraceptive patch (norelgestromin 150 µg + EE 20 µg), Outcome three Nausea.

iv

Immediate band (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg)

Issue or subgroup title No. of studies No. of participants Statistical method Effect size
1 Pregnancy per adult female ane 201 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]
two Discontinued method in 84‐day catamenia 1 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.84 [0.33, 2.18]
3 Frequent haemorrhage (> iv episodes of haemorrhage or spotting) 1 156 Peto Odds Ratio (Peto, Stock-still, 95% CI) 0.23 [0.05, 1.03]
4 Irregular haemorrhage (bleeding‐free interval > 17 days) i 156 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.77 [0.33, i.75]
5 Prolonged haemorrhage (bleeding or spotting episode lasting >= x days) 1 156 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.42 [0.20, 0.89]
six Amenorrhea ane 156 Odds Ratio (G‐H, Stock-still, 95% CI) 0.0 [0.0, 0.0]
7 Very satisfied with method 1 174 Peto Odds Ratio (Peto, Stock-still, 95% CI) 2.88 [1.59, 5.22]
viii Planned to utilise method 1 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 2.51 [one.32, four.77]
9 Reported bad change in weight ane 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.42 [0.21, 0.87]
x Reported bad alter in bleeding one 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.28 [0.14, 0.55]
11 Reported bad change in headache i 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.53 [0.24, i.18]
12 Reported bad change in breasts 1 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.36 [0.18, 0.73]
13 Reported bad modify in mood 1 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.36 [0.19, 0.69]
14 Reported bad alter in acne ane 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.39 [0.59, iii.29]
15 Reported bad change in appetite one 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.44 [0.21, 0.95]
16 Reported bad change in nausea 1 174 Peto Odds Ratio (Peto, Stock-still, 95% CI) 0.30 [0.fourteen, 0.62]
17 Reported bad change in cramps i 145 Peto Odds Ratio (Peto, Stock-still, 95% CI) 0.79 [0.37, ane.67]
xviii Reported bad change in hair one 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.28 [0.05, 1.65]
19 Serious adverse events (total) one 174 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]

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Comparing 4 Immediate ring (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Outcome 1 Pregnancy per woman.

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Comparing four Immediate band (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE xxx µg), Consequence ii Discontinued method in 84‐day catamenia.

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Comparison four Immediate ring (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE xxx µg), Upshot 3 Frequent haemorrhage (> 4 episodes of bleeding or spotting).

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Comparison 4 Immediate band (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Outcome 4 Irregular bleeding (bleeding‐complimentary interval > 17 days).

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Comparison 4 Firsthand ring (etonogestrel 120 µg + EE 15 µg) versus firsthand COC (NGM 180/215/250 µg + EE xxx µg), Result five Prolonged bleeding (haemorrhage or spotting episode lasting >= x days).

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Comparison iv Immediate ring (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE xxx µg), Outcome 6 Amenorrhea.

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Comparison iv Immediate ring (etonogestrel 120 µg + EE xv µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Event 7 Very satisfied with method.

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Comparing 4 Immediate ring (etonogestrel 120 µg + EE 15 µg) versus firsthand COC (NGM 180/215/250 µg + EE 30 µg), Outcome 8 Planned to apply method.

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Comparison four Immediate ring (etonogestrel 120 µg + EE fifteen µg) versus firsthand COC (NGM 180/215/250 µg + EE 30 µg), Event 9 Reported bad change in weight.

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Comparison 4 Immediate ring (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Issue x Reported bad change in haemorrhage.

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Comparison iv Firsthand ring (etonogestrel 120 µg + EE 15 µg) versus firsthand COC (NGM 180/215/250 µg + EE 30 µg), Outcome 11 Reported bad change in headache.

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Comparison four Immediate ring (etonogestrel 120 µg + EE 15 µg) versus firsthand COC (NGM 180/215/250 µg + EE 30 µg), Outcome 12 Reported bad modify in breasts.

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Comparison 4 Immediate band (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Outcome 13 Reported bad modify in mood.

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Comparison four Firsthand ring (etonogestrel 120 µg + EE fifteen µg) versus immediate COC (NGM 180/215/250 µg + EE thirty µg), Outcome xiv Reported bad change in acne.

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Comparing 4 Immediate ring (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Outcome 15 Reported bad change in ambition.

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Comparison 4 Immediate band (etonogestrel 120 µg + EE xv µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Outcome sixteen Reported bad change in nausea.

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Comparing 4 Immediate ring (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Upshot 17 Reported bad modify in cramps.

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Comparison 4 Immediate band (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE 30 µg), Outcome eighteen Reported bad change in pilus.

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Comparing 4 Firsthand band (etonogestrel 120 µg + EE 15 µg) versus immediate COC (NGM 180/215/250 µg + EE thirty µg), Outcome 19 Serious adverse events (total).

5

Immediate DMPA versus contraceptive bridge to DMPA

Outcome or subgroup title No. of studies No. of participants Statistical method Upshot size
1 Pregnancy per woman 1 333 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.36 [0.xvi, 0.84]
two Discontinued method before half-dozen months 1 333 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.64 [0.37, ane.eleven]
3 Very satisfied with method at half dozen months one 227 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.99 [1.05, 3.77]
iv Adverse events 1 333 Peto Odds Ratio (Peto, Stock-still, 95% CI) 0.0 [0.0, 0.0]

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Comparison 5 Immediate DMPA versus contraceptive bridge to DMPA, Outcome i Pregnancy per woman.

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Comparison 5 Firsthand DMPA versus contraceptive span to DMPA, Outcome 2 Discontinued method before vi months.

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Comparing v Immediate DMPA versus contraceptive bridge to DMPA, Outcome 3 Very satisfied with method at half-dozen months.

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Comparison 5 Immediate DMPA versus contraceptive bridge to DMPA, Outcome 4 Adverse events.

Characteristics of studies

Characteristics of included studies [ordered past study ID]

Methods Randomized controlled trial ("pilot investigation") conducted at a university hospital in Pittsburgh (USA).
Sample size adding based on ability to observe difference in continuation rates for immediate start (87%) versus traditional offset (60%).
Participants 60 women recruited via newspaper advertisements and flyers. Inclusion criteria: eighteen to 45 years one-time, asking transdermal commitment for contraception, willing to comply with protocol and visit schedule, willing to answer questionnaires.
Exclusion criteria: contraindication to combined contraceptive hormones, unprotected sex since last menstrual period > 120 hours earlier enrollment, contempo ballgame without a subsequent period, and weight > 90 kg.
Interventions Immediate initiation (Due north=30) versus traditional start (North=30) of contraceptive patch (norelgestromin 150 µg + EE twenty µg); treatment elapsing 3 cycles. For traditional start, participants were to beginning on the first 24-hour interval on their next menses.
Outcomes Continuation rates, side effects, breakthrough haemorrhage.
Analysis was washed past intent‐to‐treat.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (choice bias) Unclear risk No mention of method for generating randomization sequence.
Resource allotment darkening (selection bias) Unclear run a risk No information
Blinding (functioning bias and detection bias)
All outcomes
High risk Open‐label
Incomplete outcome data (compunction bias)
All outcomes
Low gamble Lost to follow‐up: 2%; by group, quick commencement zero and traditional start ane/30 = 3%.
Methods Randomized controlled trial at a family planning clinic in New York City (Usa). Sample size adding based on ability to discover deviation in continuation rates of 17%.
Participants 333 women (age fourteen to 26 years) who sought care at a family planning clinic and were interested in using DMPA. Exclusion criteria: currently menstruating, pregnant, or breastfeeding; contraindication to hormonal contraception; using DMPA (inside past 14 weeks); consistently used nascence control pills, patch, ring, or other prescription contraception method in past xxx days; history of serious mental illness.
Interventions Firsthand DMPA (depot medroxyprogesterone acetate) (Due north=101) versus 'bridge' method (option of pills, patch, or ring with a 21‐day supply prior to start DMPA injection) (North=232); treatment duration 6 months.
Outcomes Pregnancy, continuation, satisfaction, adverse events.
Assay was by intent‐to‐treat, except for satisfaction, which only included those who completed the visit interview.
Notes Women who discontinued their method were followed for discontinuation interview by phone or face up‐to‐face up. Interview addressed sexual behaviors, current contraception, and reasons for discontinuing method. Women who completed the interview are not included in the losses to follow‐upwardly.
Risk of bias
Bias Authors' sentence Back up for judgement
Random sequence generation (selection bias) Low run a risk Randomization sequence developed from a random number table.
Resource allotment darkening (pick bias) Low gamble Sequential sealed envelopes
Blinding (performance bias and detection bias)
All outcomes
Loftier risk Not blinded
Incomplete event data (attrition bias)
All outcomes
High risk Lost to follow: 32% overall; by grouping, Depo Now 32/101 = 32%; bridge method 74/232 = 32%.
Methods Randomized controlled trial at a university medical eye in New York City (Usa).
Sample size calculation was based on detecting difference of iii or more bleeding or spotting days during ninety‐day reference flow.
Participants 113 women recruited by local advertisements. Inclusion criteria: 18 to 35 years sometime, English‐ or Spanish‐speaking, regular menstrual cycles of 21 to 35 days in past 12 months, no contraindication to OC employ, no hormonal contraception for > 2 menses (or > 6 menstruation for injectables), > two menses since last pregnancy, no emergency contraception in current bicycle.
Exclusion criteria: positive pregnancy test or unprotected sex 10 days before screening.
Interventions Firsthand (North=67) versus conventional get-go (Northward=46) of oral contraceptives (norethindrone ane mg + EE 35 µg). Immediate: took commencement pill with direct observation. Conventional: instructed to accept commencement pill on first Sunday later on menses onset. Reference menstruation of ninety days from handling start.
Outcomes Bleeding patterns, discontinuation, satisfaction.
Analysis was by intent‐to‐treat for pregnancy and discontinuation. For other outcomes, the authors reported those who had data collected (were not lost to follow‐up and did not discontinue method).
Notes
Chance of bias
Bias Authors' judgement Back up for judgement
Random sequence generation (pick bias) Depression risk Randomization sequence was generated with random numbers table prior to report recruitment. Participants had threescore% chance of allocation to quick start and xl% chance of allotment to conventional start.
Allotment concealment (choice bias) Low take chances Sequentially‐numbered opaque sealed envelopes
Blinding (performance bias and detection bias)
All outcomes
Unclear run a risk Abstractor of diary data was blinded to group assignment.
Incomplete event data (attrition bias)
All outcomes
Low risk Lost to follow‐upwardly: 1.five% overall; by group, immediate start zero; conventional start 1/46 = ii%
One woman was excluded (prior to receiving report product) due to not having met the inclusion criteria.
Methods Open‐label randomized trial in metropolitan university‐affiliated clinic in New York City (USA).
Report provided data on a priori power adding ‐ based on detecting difference of 4 or more haemorrhage or spotting days during 84‐day reference period.
Participants 201 women recruited through flyers and internet postings. Inclusion criteria: English‐speaking, eighteen to xl years old, regular menstrual cycles, no contraindication to hormonal contraception, no hormonal contraceptive utilize in by 2 menses (or 6 menstruum for injectables), > 2 menses since pregnancy, no recent utilise of emergency contraception, and no unprotected sexual practice in past ten days.
Interventions Firsthand get-go: vaginal ring releasing etonogestrel 120 µg + EE fifteen µg daily (North=101) versus triphasic COC containing norgestimate 180/215/250 µg + EE 25 µg (N=100); treatment duration 84 days.
Outcomes Pregnancy, continuation, cycle control, satisfaction, side effects.
Analysis was by intent‐to‐treat for pregnancy. For other outcomes, the authors reported those who completed follow‐up and had bleeding diaries, which they referred to as ITT.
Notes
Run a risk of bias
Bias Authors' judgement Support for sentence
Random sequence generation (selection bias) Low risk Researcher not involved in study generated assignments with random number table and simple randomization.
Allocation concealment (option bias) Low risk Sequentially‐numbered opaque sealed envelopes.
Blinding (performance bias and detection bias)
All outcomes
Unclear take chances No mention of blinding other than 'Study coordinator and interviewers were blinded to assignment before opening the envelope.'
Incomplete outcome data (compunction bias)
All outcomes
Low adventure Lost to follow‐upwards: overall 27/201 = xiii%; ring 12/101 = 12% and COC 15/100 = 15%.
Methods Randomized controlled trial in family planning clinics ‐ three university sites in the USA. Sample size calculation based on detecting continuation increment from 50% to lx% at 6 months. Power was 63% to detect pregnancy decrease from eleven% to 7%.
Participants 1720 young women requesting OCs. Inclusion criteria: < 25 years sometime, not pregnant, sexually active, no OC in past 7 days or DMPA in vi months, no want for pregnancy in next six months, no lactational amenorrhea. Exclusion criteria (IRB required): postpartum or postabortion if less than 18 years erstwhile.
Interventions Firsthand start (N=856) versus conventional initiation (Northward=864) of OC.
Immediate: start pill was taken under direct observation.
Conventional: instructed to accept get-go pill during next flow. Clinician preference determined OC brand and number of pill packs or prescriptions provided. Study duration 6 months.
Outcomes Pregnancy and serious agin events. Insufficient data were reported for computing method discontinuation.
Analysis for pregnancy included those who "had well‐dated pregnancies that began during the written report." The denominator for SAEs did not include the women that the researchers excluded due to pregnancy prior to baseline and those who had other violations of inclusion criteria.
Notes Medical records were used to place pregnancy in 96 women who missed both follow‐ups.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (option bias) Low risk Randomization via random number generator; coordinating eye generated allocation schedule.
Allocation darkening (selection bias) Low risk Numbered opaque envelopes
Blinding (performance bias and detection bias)
All outcomes
Unclear risk No information
Incomplete outcome data (compunction bias)
All outcomes
Low take chances Lost to follow‐up: 16% overall past group, immediate start 128/846 = 15%; conventional initiation 135/837 = xvi%.
Excluded 4 women due to not having met the inclusion criteria and 33 women who initially had a negative pregnancy test but whose estimated formulation engagement (based on ultrasound) preceded enrollment.

Characteristics of excluded studies [ordered by written report ID]

Study Reason for exclusion
Bednarek 2008 Bleeding assessed from first dose of medication for abortion until all bleeding stopped (not related to cycle control). Contraception continuation assessed at 6 weeks after abortion. Results grouped for contraceptive pill, patch, or ring (women chose method).
Offered participation in sub‐written report (of medical abortion RCT) at first follow‐upwardly, half-dozen to 8 days after ballgame. Observed start during that visit. Comparison group to begin the first Dominicus following visit (not menses‐dependent).
Karjane 2011 Study was terminated due to recruitment problems (ClinicalTrials.gov last updated 20 Oct 2011)
Madden 2011 Women were non randomized to immediate and delayed get-go groups.
Martin 1998 This trial studied iv different approaches to decreasing bleeding after medical ballgame and was not a contraception trial.
Paseková 2003 Non‐comparative written report of oral contraceptive outset based on menses
Sitavarin 2003 Oral contraceptive start at two unlike times (both based on flow)
Were 1997 Oral contraceptive start based on length of time postpartum or return of menses
Yeshaya 1998 Oral contraceptive start based on menses

Characteristics of studies awaiting assessment [ordered by study ID]

Methods Randomized controlled trial conducted in Nicaragua; designed to have 85% power to detect 20% deviation in COC continuation and iii‐twenty-four hours difference in bleeding and spotting days per trimester.
Participants 232 women. Inclusion criteria: regular menses; not in start 7 days of bike
Interventions 30 µg COC: quick start (Northward=116) or accelerate provision (N=116)
Outcomes Chief: pill continuation at 6 months
Secondary: bleeding patterns and half dozen‐calendar month pregnancy rates
Notes thirty Aug 2012: Researcher communicated that report was drafted only not peer‐reviewed
Contact: K Nanda, FHI 360, Research Triangle Park, NC; knanda@fhi360.org
Methods RCT, open label
Participants 300 women.
Inclusion Criteria: woman aged thirteen to 45 who presents to Women's Options Clinic and desires to utilise patch for post‐abortion contraception
Exclusion Criteria: gestational age higher up 23 weeks and 1 day; contraindication for patch utilize (smoking > xx cigarettes a mean solar day over age 35, history of venous thromboembolic effect or pulmonary embolism, ischemic heart disease, stroke; vascular disease, complicated valvular middle affliction [pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis], claret force per unit area >160/100, migraines with focal neurologic symptoms, current breast cancer, active viral hepatitis, severe cirrhosis, or liver tumor); speak language other than English or Spanish; no phone or have phone where contact might compromise confidentiality of the abortion
Interventions All receive a month's worth of patch and one‐yr prescription
Immediate start: place get-go patch in the clinic, observed by clinic staff, before leaving.
Control: instructed to place first patch on start Sunday post-obit ballgame;
follow‐up by telephone interview at 2 and half dozen months after ballgame
Outcomes Primary: continuation of patch subsequently abortion
Secondary: compliance with patch after abortion, bleeding patterns on [patch] after ballgame, satisfaction with patch after abortion
Notes Start date: Aug 2005.
11 Oct 2012: JE Steinauer corresponded that they recently submitted a draft manuscript for publication consideration.
Methods RCT, open label
Participants 300 women.
Inclusion Criteria: woman aged thirteen to 45 who presents to Women's Options Clinic and desires to use OCs for mail service‐abortion contraception.
Exclusion Criteria: gestational age above 23 weeks + 1 mean solar day; contraindication for combination OC utilize (smoking > 20 cigarettes a twenty-four hours over age 35, history of venous thromboembolic event or pulmonary embolism, ischemic center disease, stroke; vascular affliction, complicated valvular heart illness [pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis], claret pressure >160/100, migraines with focal neurologic symptoms, current breast cancer, active viral hepatitis, severe cirrhosis, or liver tumor); speak language other than English or Spanish; no telephone or accept telephone where contact might compromise confidentiality of the ballgame
Interventions All receive single pack of combination OCs and one‐year prescription.
Immediate offset: take first OC in dispensary, observed by clinic staff, before leaving.
Command: instructed to begin OCs on get-go Sunday post-obit abortion;
follow‐up by telephone interview at 2 and half-dozen months subsequently ballgame
Outcomes Main: continuation of OCs after abortion
Secondary: compliance with OCs later on abortion, bleeding patterns on OCs afterward abortion, satisfaction with OCs after abortion
Notes Start date: Aug 2005.
xi October 2012: JE Steinauer corresponded that they will shortly submit a typhoon manuscript for publication consideration.

Differences betwixt protocol and review

In 2012, we added to Types of studies: Handling elapsing had to be at least three cycles or 84 days.

Contributions of authors

S Newmann and D Grimes developed the concept. S Newmann drafted the protocol, reviewed the initial searches, and began information abstraction. Fifty Lopez completed the searches for the review, did the chief data abstraction, and drafted the review; she besides updated the review in 2010 and 2012. D Grimes did the second information extraction and edited and advised on the review. K Nanda edited and advised on the review. Grand Schulz provided statistical expertise and edited the review.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • US Bureau for International Development, Usa.

  • National Institute of Child Wellness and Homo Development, The states.

Declarations of interest

DA Grimes has consulted with the pharmaceutical companies Bayer Healthcare Pharmaceuticals and Merck & Co, Inc.

Grand Nanda is the chief investigator of a trial on this discipline; the results may be included in an update.

References

References to studies included in this review

Murthy 2005 {published information simply}

  • Murthy A, Creinin One thousand, Harwood B, Schreiber C. Aforementioned‐day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods. Contraception 2005;72:333‐half dozen. [PubMed] [Google Scholar]

Rickert 2007 {published data only}

  • Rickert V, Tiezzi L, Lipshutz J, Leon J, Vaughan R, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. Journal of Adolescent Health 2007;40:22‐eight. [PubMed] [Google Scholar]

Westhoff 2003 {published information only}

  • Westhoff C, Morroni C, Kerns J, Murphy PA. Haemorrhage patterns after firsthand vs. conventional oral contraceptive initiation: a randomized, controlled trial. Fertility and Sterility 2003;79:322‐9. [PubMed] [Google Scholar]

Westhoff 2005 {published data only}

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Karjane 2011 {published data only (unpublished sought but not used)}

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Madden 2011 {published information only}

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6956679/