Emily M. Godfrey

Copper T380 intrauterine device for emergency contraception: highly effective at any time in the menstrual cycle

STUDY QUESTION Does the efficacy of placing a copper intrauterine device (IUD) for emergency contraception (EC) to prevent pregnancy depend on menstrual cycle timing and timing of unprotected intercourse (UPI)? SUMMARY ANSWER If the urine pregnancy test is negative prior to IUD placement, the copper IUD is highly effective for EC at any point in the menstrual cycle. WHAT IS KNOWN ALREADY The use of the Copper T380A for EC has been encouraged by the failure of oral EC methods to decrease rates of unintended pregnancy and the documented success of the IUD in reducing unintended pregnancies. However scant data exist regarding the efficacy and safety of IUD insertion for EC when accounting for menstrual cycle timing and time since UPI. STUDY DESIGN, SIZE, DURATION This is a secondary analysis of data obtained from a previously published prospective cohort study of women who received the Copper T380A IUD for EC between July 1997 and January 2000. We included 1840 participants according to the study inclusion criteria of a known last menstrual period (LMP) and cycle lengths of 25-35 days. PARTICIPANTS/MATERIALS, SETTING, METHODS The original study included women aged between 18 and 44 years who presented for EC at 18 sites throughout China and who had regular menstrual cycles between 24 and 42 days, a known LMP, UPI within 120 h (5 days) and a negative urine pregnancy test (cutoff <25 IU/ml). Women with uncertain LMP dates were excluded. This study included only participants with cycle lengths of 25-35 days. MAIN RESULTS AND THE ROLE OF CHANCE Among the 1840 participants with usual cycle lengths of 25-35 days, 850 (46.2%) had their IUD inserted following UPI in the expected fertile window and 84 (4.6%) had the insertion >5 days after the predicted ovulation day and 52 (2.8%) had the insertion >5 days after UPI. There were no pregnancies in the first month among the 1771 women who had information available regarding their 1-month follow-up pregnancy test. LIMITATIONS, REASONS FOR CAUTION This was a secondary analysis of an observational study, and thus participants were not randomized to an alternative postcoital method. There were a small number of women who had UPI >5 days after their predicted ovulation day thus limiting the confidence of assuring a low risk of pregnancy in this situation. The ovulation day was calculated based on the LMP prior to IUD insertion and not on the subsequent first day of menses following IUD insertion. WIDER IMPLICATIONS OF THE FINDINGS If the urine pregnancy test is negative prior to IUD placement, the copper IUD is likely to be effective for EC at almost any point in the menstrual cycle. STUDY FUNDING/COMPETING INTEREST(S) The original study was funded by the UNDP/UNPFA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. The donors and sponsors of the study had no role in the study design, data collection, data analysis, data interpretation, writing of the report or the decision to submit the paper for publication.

Treatment of bleeding irregularities in women with copper-containing IUDs: a systematic review

BACKGROUND Bleeding irregularities, such as intermenstrual spotting or heavy or prolonged menstrual bleeding, are common among copper-containing intrauterine device (Cu-IUD) users and are one of the leading reasons for method discontinuation. This review evaluates the evidence for effective therapeutic and preventive treatments for bleeding irregularities during Cu-IUD use. STUDY DESIGN We searched the PubMed database for peer-reviewed articles that were published in any language from inception of the database through March 2012 and were relevant to treatments for irregular bleeding during Cu-IUD use. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence. RESULTS From 1470 articles, we identified 17 articles that met our inclusion criteria. Evidence from two studies of poor quality demonstrated that antifibrinolytic agents or nonsteroidal anti-inflammatory drugs (NSAIDs) have been used for intermenstrual bleeding or spotting among a small number of Cu-IUD users with mixed results. Evidence from 10 studies of fair to poor quality suggested that some NSAIDs may significantly reduce menstrual blood loss or bleeding duration among Cu-IUD users with heavy or prolonged menstrual bleeding. Antifibrinolytic drugs or antidiuretics may also help reduce blood loss. High-dose aspirin was shown to increase blood loss among those with baseline menorrhagia. Evidence from five studies of fair to poor quality suggested that bleeding irregularities among new Cu-IUD users may be prevented with NSAIDs, although one large study of good quality suggested that prophylactic treatment with ibuprofen does not affect continuation of Cu-IUD use. Evidence from two studies of fair to poor quality suggested that antifibrinolytic agents might be helpful in preventing heavy or prolonged menstrual bleeding among new Cu-IUD users. CONCLUSIONS Limited evidence suggests that NSAIDs may be effective treatments for bleeding irregularities associated with Cu-IUD use; antifibrinolytic agents and antidiuretics have also been studied as possible treatments in a small number of subjects, but their safety has not been well documented. NSAIDs and antifibrinolytics may also prevent bleeding irregularities among new CU-IUD users. Preventive NSAID use, however, does not impact Cu-IUD continuation.

Evidence-Based Selection of Candidates for the Levonorgestrel Intrauterine Device (IUD)

Background: Recent evidence-based guidelines expanded the definition of appropriate candidates for the levonorgestrel-releasing intrauterine system (LNG-IUS). We investigated correlates of evidence-based selection of candidates for the LNG-IUS by physicians who offer insertion. Methods: We conducted a mixed-mode (online and mail) survey of practicing family physicians and obstetrician-gynecologists in Seattle. Results: A total of 269 physicians responded to the survey (44% response rate). Of the 217 respondents who inserted intrauterine devices, half or fewer routinely recommended the LNG-IUS to women who are nulliparous, younger than 20 years old, or have a history of sexually transmitted infections (STIs). In multivariable analyses, training/resident status was positively associated with recommending the LNG-IUS to women <20 years old (adjusted odds ratio [aOR], 3.6; 95% confidence interval [CI], 1.6–8.0) and women with history of STI (aOR, 3.7; 95% CI, 1.6–8.4). Perceived risk of infection or infertility was negatively associated with recommending the LNG-IUS to nulliparous women (aOR, 0.2; 95% CI, 0.1–0.5) and women with a history of STI (aOR, 0.3; 95% CI, 0.1–0.8). Conclusions: Many family physicians and obstetrician-gynecologists who insert the LNG-IUS are overly restrictive in selecting candidates, although those who train residents are more likely to follow evidence-based guidelines. Interventions that address negative bias and perceptions of risks, in addition to improving knowledge, are needed to promote wider use of the LNG-IUS.

Evidence-based guidance on selected practice recommendations for contraceptive use: identification of research gaps

This paper seeks to address the gaps in research regarding recommendations for contraceptive use. There are three primary questions to be answered question the patient and provider understanding of adherence instructions to contraceptives prevention of bleeding irregularities among women using hormonal and intrauterine contraception and the long term effectiveness of hysteroscopic sterilization. Although this paper does discuss findings that answer these questions the purpose of the paper is to facilitate more research in these areas. Lastly the paper calls for more research in this field focusing on sensitive subgroups in the population that are likely to react differently to contraceptives. Copyright

Treatment of unscheduled bleeding in women using extended- or continuous-use combined hormonal contraception: a systematic review

BACKGROUND Unscheduled uterine bleeding is common among women who choose extended or continuous combined hormonal contraception and may subsequently lead to method discontinuation. This systematic review evaluates the evidence on treatments for unscheduled bleeding for women using continuous or extended combined hormonal contraception. STUDY DESIGN We searched the PubMed database for peer-reviewed articles that were published in any language from inception of the database through January 2012 and were relevant to therapeutic or prophylactic treatments for unscheduled uterine bleeding during extended or continuous combined hormonal contraception use. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence. RESULTS Four articles met the inclusion criteria. Evidence from two randomized controlled trials, both of fair quality, suggested that a short hormone-free interval of 3 or 4 days improved a current unscheduled bleeding episode. Evidence from one randomized controlled trial of fair quality suggested that oral doxycycline (100 mg twice daily) did not improve a current unscheduled bleeding episode. One good quality randomized controlled trial suggested that prophylactic treatment with a daily low dose of oral doxycycline (40 mg) caused earlier onset of amenorrhea in new extended combined oral contraceptive users. CONCLUSIONS Limited evidence suggests that introducing a short hormone-free interval when unscheduled bleeding occurs during continuous or extended hormonal contraceptive use may reduce unscheduled bleeding days; one study suggests that twice-daily oral doxycycline initiated at the time of unscheduled bleeding is an ineffective treatment. Limited data suggest that prophylactic low-dose daily oral doxycycline may induce earlier amenorrhea among new extended combined hormonal contraceptive users.

Helping Clinicians Prevent Pregnancy among Sexually Active Adolescents: U.S. Medical Eligibility Criteria for Contraceptive Use and U.S. Selected Practice Recommendations for Contraceptive Use

The United States has made substantial progress in reducing teenage birth rates in recent decades, but rates remain high. Teen pregnancy can increase the risk of poor health outcomes and lead to decreased educational attainment, increased poverty, and welfare use, as well as increased cost to taxpayers. One of the most effective ways to prevent teenage pregnancy is through the use of effective birth control methods. The Centers for Disease Control (CDC) and Prevention has made the prevention of teenage pregnancy 1 of its 10 winnable battles. The CDC has released 2 evidence-based clinical guideline documents regarding contraceptive use for adolescents and adults. The first guideline, US Medical Eligibility Criteria for Contraceptive Use, 2010, helps clinicians recognize when a contraceptive method may not be safe to use for a particular adolescent but also when not to withhold a contraceptive method that is safe to use. The second document, US Selected Practice Recommendations for Contraceptive Use, 2013, provides guidance for how to use contraceptive methods safely and effectively once they are deemed safe. Health care providers are encouraged to use these documents to provide safe and effective contraceptive care to patients seeking family planning, including adolescents.

Pregnancy among cystic fibrosis women in the era of CFTR modulators

BACKGROUND Little is known about how new therapies that partially correct the basic cystic fibrosis (CF) defect (ivacaftor and lumacaftor) might alter hormonal contraceptive effectiveness, impact pregnancy outcomes, or affect pregnancy timing. Examination of pregnancy rates among CF women during periods of CFTR modulator therapy initiation will provide foundation for further research in this area. METHODS The Cystic Fibrosis Foundation Patient Registry was used to examine pregnancy rates and outcomes by genotype class before, during, and after the introduction of CFTR modulator therapies between 2005 and 2014. RESULTS Among women with CF, ages 15-44years, there was a slight downward trend in annual pregnancy rates from 2005 to 2014 (2% reduction per year, p=0.041). Among women with G551D, pregnancy rates during phase 3 ivacaftor trial years was 14.4/1000 women-years compared to 34.0/1000 prior to the trial period (relative risk [RR]=0.65; 95% CI=0.43-0.96; p=0.011) and 38.4/1000 after drug approval in June 2012 (RR=1.52 post-approval compared to trial period; 95% CI=1.26, 1.83; p<0.001). Pregnancy outcomes did not significantly change between 2005 and 2014 for any genotype class. CONCLUSION Evidence of significantly increased numbers of pregnancies among women taking approved CFTR modulators is important because of the unknown risk to pregnancy and fetal outcomes. Increases may be temporary following pregnancy prevention during controlled clinical trials, or from altered perceptions about maternal survival with new approved treatments. As more women with CF become eligible to receive modulators, the CF community must study their effect on contraceptive efficacy and safety during pregnancy. With increased health and survival due to modulation, family planning topics will become more common in CF.

Prevention and management of nausea and vomiting with emergency contraception: a systematic review☆

BACKGROUND Nausea and vomiting are side effects of emergency contraception pill (ECP) use. Different ECP regimens and the use of antinausea drugs may prevent these side effects. METHODS We conducted two searches to identify data pertaining to the prevention of nausea and vomiting with ECP use and management of emesis with ECP use. Both searches queried the PubMed and Cochrane databases for peer-reviewed articles, in any language, published on January 1966-February 2012. Types of ECP included in our searches were levonorgestrel (LNG), Yuzpe regimens or ulipristal acetate (UA). Our search strategy for data on management of emesis with ECP use also included the gray literature. The gray literature includes materials such as reports, patent claims, prescribing information and package labels that are not published commercially. RESULTS Eleven articles met the inclusion criteria. Split dose or two doses of LNG caused less nausea than UA and standard two-dose Yuzpe regimen in one study. Four studies demonstrated no difference between split-dose versus single-dose LNG. In two trials, meclizine and metoclopramide, given before Yuzpe ECPs, reduced nausea, but only meclizine reduced vomiting. CONCLUSION The evidence does not support routine use of antiemetics with ECP use. Data to guide management of emesis with ECP are limited to expert opinion and package labeling.

2016 Updates to US Medical Eligibility Criteria for Contraceptive Use and Selected Practice Recommendations for Contraceptive Use: Highlights for Adolescent Patients

The US Medical Eligibility Criteria for Contraceptive Use (MEC) and US Selected Practice Recommendations for Contraceptive Use (SPR) provide evidence-based guidance to safely provide contraception counseling and services. Both documents were updated in 2016 and are endorsed by the North American Society for Pediatric and Adolescent Gynecology. The purpose of this mini-review is to highlight updates to the US MEC and US SPR that are most relevant to health care providers of adolescents to support dissemination and implementation of these evidence-based best practices. This document is intended to highlight these changes and to complement, not replace, the detailed practice guidance within the US MEC and US SPR.

Use of an electronic health record data sharing system for identifying current contraceptive use within the WWAMI region Practice and Research Network

OBJECTIVE To evaluate the ability of electronic health record (EHR) data extracted into a data-sharing system to accurately identify contraceptive use. STUDY DESIGN We compared rates of contraceptive use from electronic extraction of EHR data via a data-sharing system and manual abstraction of the EHR among 142 female patients ages 15-49 years from a family medicine clinic within a primary care practice-based research network (PBRN). Cohens kappa coefficient measured agreement between electronic extraction and manual abstraction. RESULTS Manual abstraction identified 62% of women as contraceptive users, whereas electronic extraction identified only 27%. Long acting reversible (LARC) methods had 96% agreement (Cohens kappa 0.78; confidence interval, 0.57-0.99) between electronic extraction and manual abstraction. EHR data extracted via a data-sharing system was unable to identify barrier or over-the-counter contraceptives. CONCLUSIONS Electronic extraction found substantially lower overall rates of contraceptive method use, but produced more comparable LARC method use rates when compared to manual abstraction among women in this studys primary care clinic. IMPLICATIONS Quality metrics related to contraceptive use that rely on EHR data in this studys data-sharing system likely under-estimated true contraceptive use.