Tara C. Jatlaoui

U.S. Medical Eligibility Criteria for Contraceptive Use, 2016

The 2016 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by women and men who have certain characteristics or medical conditions. These recommendations for health care providers were updated by CDC after review of the scientific evidence and consultation with national experts who met in Atlanta, Georgia, during August 26-28, 2015. The information in this report updates the 2010 U.S. MEC (CDC. U.S. medical eligibility criteria for contraceptive use, 2010. MMWR 2010:59 [No. RR-4]). Notable updates include the addition of recommendations for women with cystic fibrosis, women with multiple sclerosis, and women receiving certain psychotropic drugs or St. Johns wort; revisions to the recommendations for emergency contraception, including the addition of ulipristal acetate; and revisions to the recommendations for postpartum women; women who are breastfeeding; women with known dyslipidemias, migraine headaches, superficial venous disease, gestational trophoblastic disease, sexually transmitted diseases, and human immunodeficiency virus; and women who are receiving antiretroviral therapy. The recommendations in this report are intended to assist health care providers when they counsel women, men, and couples about contraceptive method choice. Although these recommendations are meant to serve as a source of clinical guidance, health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients. Persons should seek advice from their health care providers when considering family planning options.

U.S. Selected Practice Recommendations for Contraceptive Use, 2016

The 2016 U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR) addresses a select group of common, yet sometimes controversial or complex, issues regarding initiation and use of specific contraceptive methods. These recommendations for health care providers were updated by CDC after review of the scientific evidence and consultation with national experts who met in Atlanta, Georgia, during August 26-28, 2015. The information in this report updates the 2013 U.S. SPR (CDC. U.S. selected practice recommendations for contraceptive use, 2013. MMWR 2013;62[No. RR-5]). Major updates include 1) revised recommendations for starting regular contraception after the use of emergency contraceptive pills and 2) new recommendations for the use of medications to ease insertion of intrauterine devices. The recommendations in this report are intended to serve as a source of clinical guidance for health care providers and provide evidence-based guidance to reduce medical barriers to contraception access and use. Health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients. Persons should seek advice from their health care providers when considering family planning options.

Postplacental intrauterine device insertion at a teaching hospital.

OBJECTIVE To determine whether postplacental intrauterine device (IUD) insertion can be safely and effectively performed within a teaching program. STUDY DESIGN This was a prospective cohort of 177 subjects planning vaginal delivery enrolled antenatally who desired postplacental IUD insertion of either the copper T380A IUD or levonorgestrel IUS. Insertions were performed primarily by resident physicians following a training session. Follow-up included a 4- to 8-week visit and telephone calls at 3 and 6 months. RESULTS Ninety-nine subjects underwent successful postplacental IUD insertion of 100 attempts. Seventeen expulsions (17%) were noted: 10 complete and 7 partial. The study identified no differences in outcome by training level; however, the study lacked statistical power to evaluate anything other than large differences. CONCLUSION Postplacental IUD insertions can be safely and effectively performed within a training program. IMPLICATIONS A training protocol may safely and feasibly be initiated among physicians, advanced practice clinicians or trainees with no prior experience with postplacental IUD insertion. By initiating this practice, access to highly effective contraception may increase for patients who have difficulty returning for a visit or otherwise receiving effective methods.

Safety and effectiveness data for emergency contraceptive pills among women with obesity: a systematic review

OBJECTIVE This study aims to determine whether emergency contraceptive pills (ECPs) are less safe and effective for women with obesity compared with those without obesity. STUDY DESIGN We searched PubMed for articles through November 2015 regarding the safety and effectiveness of ECPs [ulipristal acetate (UPA), levonorgestrel (LNG) and combined estrogen and progestin] among obese users. We assessed study quality using the United States Preventive Services Task Force evidence grading system. RESULTS We identified four pooled secondary analyses (quality: poor to fair), two of which examined UPA and three examined LNG formulations. Three analyses pooled overlapping data from a total of three primary studies and demonstrated significant associations between obesity and risk of pregnancy after ECP use. One analysis reported a 4-fold increased risk of pregnancy among women with obesity (BMI≥30kg/m2) compared with women within normal/underweight categories (BMI<25kg/m2) after use of LNG ECPs [odds ratio (OR) 4.4; 95% confidence interval (CI) 2.0-9.4]. Further analysis of the same LNG data found that, at an approximate weight of 80 kg, the rate of pregnancy rose above 6%, which is the estimated pregnancy probability without contraception; at weights less than 75 kg, the rate of pregnancy was less than 2%. Two analyses examining UPA suggested an approximate 2-fold increased risk of pregnancy among women with obesity compared with either normal/underweight women or nonobese (BMI<30kg/m2) women (OR 2.6; 95% CI 0.9-7.0 and OR 2.1; 95% CI 1.0-4.3, respectively), but CIs were wide. Finally, the fourth secondary analysis pooled data from three separate randomized controlled trials on LNG ECPs and found no increase in pregnancy risk with increasing weight or BMI and found no consistent association between pregnancy and both factors when adjusted for other covariates. CONCLUSION While data are limited and poor to fair quality, findings suggest that women with obesity experience an increased risk of pregnancy after use of LNG ECP compared with those normal/underweight. Women with obesity may also experience an increased risk of pregnancy compared with women without obesity after use of UPA ECP, though differences did not reach statistical significance. Providers should counsel all women at risk for unintended pregnancy, including those with obesity, about the effectiveness of the full range of emergency contraception options in order for them to understand their options, to receive advanced supplies of emergency contraception as needed and to understand how to access an emergency copper intrauterine device if desired.

The safety of intrauterine devices among young women: a systematic review

OBJECTIVE The objective was to determine the association between use of intrauterine devices (IUDs) by young women and risk of adverse outcomes. METHODS We searched Pubmed, CINAHL, Embase, Popline and the Cochrane Library for articles from inception of database through December 2015. For outcomes specific to IUD use (IUD expulsion and perforation), we examined effect measures for IUD users generally aged 25 years or younger compared with older IUD users. For outcomes of pregnancy, infection, pelvic inflammatory disease (PID), and heavy bleeding or anemia, we examined young IUD users compared with young users of other contraceptive methods or no method. RESULTS We identified 3169 articles of which 16 articles from 14 studies met our inclusion criteria. Six studies (Level II-2, good to poor) reported increased risk of expulsion among younger age groups compared with older age groups using copper-bearing (Cu-) IUDs. Two studies (Level II-2, fair) examined risks of expulsion among younger compared with older women using levonorgestrel-releasing (LNG-) IUDs; one reported no difference in expulsion, while the other reported increased odds for younger women. Four studies (Level II-2, good to poor) examined risk of expulsion among Cu- and LNG-IUD users combined and reported no significant differences between younger and older women. For perforation, four studies (Level II-2, fair to poor) found very low perforation rates (range, 0%-0.1%), with no significant differences between younger and older women. Pregnancies were generally rare among young IUD users in nine studies (Level I to II-2, fair to poor), and no differences were reported for young IUD users compared with young combined oral contraceptive (COC) or etonogestrel (ENG) implant users. PID was rare among young IUD users; one study reported no cases among COC or IUD users, and one reported no difference in PID among LNG-IUD users compared with ENG implant users from nationwide insurance claims data (Level I to II-2, fair). One study reported decreased odds of bleeding with LNG-IUD compared with COC use among young women, while one study of young women reported decreased odds of removal for bleeding with LNG-IUD compared with ENG implant (Level I to II-2, fair). CONCLUSION Overall evidence suggests that the risk of adverse outcomes related to pregnancy, perforation, infection, heavy bleeding or removals for bleeding among young IUD users is low and may not be clinically meaningful. However, the risk of expulsion, especially for Cu-IUDs, is higher for younger women compared with older women. If IUD expulsion occurs, a young woman is exposed to an increased risk of unintended pregnancy if replacement contraception is not initiated. IUDs are safe for young women and provide highly effective reversible contraception.

Safety data for levonorgestrel ulipristal acetate and Yuzpe regimens for emergency contraception.

UNLABELLED The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) provide recommendations for use of emergency contraceptive pills (ECPs), including levonorgestrel (LNG) and combined oral contraceptives (COCs). A new ECP formulation, ulipristal acetate (UPA), is now available worldwide. To determine whether LNG, UPA or COC (Yuzpe) ECPs are safe for women with certain characteristics or medical conditions, we searched the PubMed and Cochrane databases for articles published from date of inception until May 2015 pertaining to the safety of LNG, UPA or Yuzpe ECP use. For direct evidence, we considered studies that looked at safety outcomes among women with certain medical conditions or characteristics taking ECPs compared with women not taking ECPs. For indirect evidence, we considered studies that reported pharmacokinetic (PK) data for ECP use among women with certain medical conditions or characteristics and studies that reported safety outcomes among healthy women taking ECPs. Five studies provided direct evidence; of these five studies, four examined LNG or Yuzpe use among pregnant or breastfeeding women, and one reported risk of ectopic pregnancy among women repeatedly using LNG ECPs. Poor pregnancy outcomes were rare among pregnant women who used LNG or Yuzpe ECPs during the conception cycle or early pregnancy. Breastfeeding outcomes did not differ between women exposed to LNG ECP and those unexposed, and there was no increased risk of ectopic pregnancy versus intrauterine pregnancy after repeated use of LNG ECPs compared with nonuse. Forty-five studies provided indirect evidence. One PK study demonstrated that LNG passes into breastmilk but in minimal quantities. In addition, nine studies examined pregnancy outcomes following ECP failure among healthy women, and 35 articles reported adverse events. Studies suggest that serious adverse events are rare among women taking any of these ECP formulations. IMPLICATIONS Evidence on safety of ECPs among women with characteristics or medical conditions listed within WHO and CDC family planning guidance is limited. However, both direct and indirect evidence for our study question did not suggest any special safety concerns for the use of ECPs among women with particular medical conditions or personal characteristics, such as pregnancy, lactation or frequent ECP use.

Medications to ease intrauterine device insertion: a systematic review

BACKGROUND Potential barriers to intrauterine device (IUD) use include provider concern about difficult insertion, particularly for nulliparous women. OBJECTIVE This study aims to evaluate the evidence on the effectiveness of medications to ease IUD insertion on provider outcomes (i.e., ease of insertion, need for adjunctive insertion measures, insertion success). SEARCH STRATEGY We searched the PubMed database for peer-reviewed articles published in any language from database inception through February 2016. SELECTION CRITERIA We included randomized controlled trials (RCTs) that examined medications to ease interval insertion of levonorgestrel-releasing IUDs and copper T IUDs. RESULTS From 1855 articles, we identified 15 RCTs that met our inclusion criteria. Most evidence suggested that misoprostol did not improve provider ease of insertion, reduce the need for adjunctive insertion measures or improve insertion success among general samples of women seeking an IUD (evidence Level I, good to fair). However, one RCT found significantly higher insertion success among women receiving misoprostol prior to a second IUD insertion attempt after failed attempt versus placebo (evidence Level I, good). Two RCTs on 2% intracervical lidocaine as a topical gel or injection suggested no positive effect on provider ease of insertion (evidence Level I, good to poor), and one RCT on diclofenac plus 2% intracervical lidocaine as a topical gel suggested no positive effect on provider ease of insertion (evidence Level I, good). Limited evidence from two RCTs on nitric oxide donors, specifically nitroprusside or nitroglycerin gel, suggested no positive effect on provider ease of insertion or need for adjunctive insertion measures (evidence Level I, fair). CONCLUSIONS Overall, most studies found no significant differences between women receiving interventions to ease IUD insertion versus controls. Among women with a recent failed insertion who underwent a second insertion attempt, one RCT found improved insertion success among women using misoprostol versus placebo.

The safety of intrauterine devices in breastfeeding women: a systematic review

OBJECTIVES To investigate levonorgestrel (LNG)-releasing and copper-bearing (Cu) intrauterine device (IUD) safety among breastfeeding women and, for Cu-IUD use, breastfeeding performance and infant health. STUDY DESIGN Systematic review. METHODS We searched PubMed, Embase, Cochrane Library and clinicaltrials.gov for articles through January 2016. We included studies of Cu-IUD or LNG-IUD users comparing IUD-specific (perforation, expulsion) and other contraceptive-related (infection, removal/cessation due to bleeding/pain and other adverse events) outcomes for breastfeeding vs. non-breastfeeding women. We also included studies of breastfeeding women comparing contraceptive-related outcome for IUD-users vs. other contraceptive-method users. Finally, we included studies comparing breastfeeding outcomes among Cu-IUD users to users of other nonhormonal contraceptives or no contraception. RESULTS Of 548 articles identified, 23 (16 studies) met the inclusion criteria. Two studies suggested that the risk of IUD perforation was 6-10 times higher among breastfeeding vs. non-breastfeeding women. Seven studies suggested that risks for other adverse events were similar or lower among breastfeeding vs. non-breastfeeding women. Three studies among breastfeeding women found no increased risk of adverse events in IUD users vs. nonusers. Breastfeeding performance and infant growth were similar for Cu-IUD users and users of other nonhormonal methods or no contraception. CONCLUSION Overall, risks for adverse events among IUD users, including expulsion, pain and removals, were similar or lower for breastfeeding women vs. non-breastfeeding women. Uterine perforation with IUDs, while rare, appeared more frequent among breastfeeding women. No evidence indicated that Cu-IUD use in breastfeeding women influences breastfeeding performance or infant growth.

Family planning knowledge, attitudes and practices among bariatric healthcare providers.

OBJECTIVE This survey aimed to identify the family planning knowledge, attitudes and practices of bariatric providers in the perioperative period. STUDY DESIGN We developed a quantitative survey based on semistructured interviews with six bariatric providers. We mailed the survey to the American Society of Metabolic and Bariatric Surgery members with plans to use data from the first 275 responders to assess knowledge, attitudes and practices regarding family planning. RESULTS Over 70% of 272 respondents recommended that women avoid pregnancy for 12-24months after bariatric procedures. Most (73.0%) considered female reproductive health discussions very important, and most feel comfortable (70.4%) with these discussions. The majority considered the most effective contraceptive methods to be safe for women after gastric bypass; only a minority (35.3%) provided contraceptive services or referrals, and few (4.9%) have accurate knowledge of contraceptive effectiveness. Respondents most frequently preferred the patients own gynecologist (80.9%) or bariatric surgeon (71.0%) discuss contraception. Discussing contraception was associated with provider age 40-49years, training region in southeast or midwest and degrees of physician assistant or nurse practitioner with adjusted odds ratios exceeding 2.0. CONCLUSION Bariatric providers consider reproductive health very important, and while most are comfortable having these conversations, few have accurate knowledge of contraceptive safety and effectiveness. Most would prefer patients see their gynecologists to discuss contraception. These findings suggest an opportunity for gynecologists to educate themselves and bariatric colleagues about contraception recommendations after bariatric surgery and collaborate with bariatric centers in their area to meet the needs of these patients. IMPLICATIONS Gynecologists must become educated and involved in the care of female bariatric patients to discuss reproductive health concerns and to counsel effectively regarding contraception after bariatric surgery.

Research gaps identified during the 2014 update of the WHO medical eligibility criteria for contraceptive use and selected practice recommendations for contraceptive use

Universal access to safe and effective contraception is an important public health goal. Family planning and prevention of unintended pregnancy are essential to securing the well-being and autonomy of individuals while supporting the health and development of communities. The World Health Organization (WHO) recently undertook a process to update its global guidance on “who” can use contraception safely and “how” to use contraception safely and effectively to generate the fifth edition of the WHO Medical Eligibility Criteria for Contraceptive Use (MEC) and the third edition of the WHO Selected Practice Recommendations for Contraceptive Use (SPR). Overall the MEC demonstrates that contraception is remarkably safe for most people; at least one highly effective contraceptive method is assigned a category “1” or “2” across the majority of conditions in the guidance indicating no restrictions on use or that the advantages of using a particular method generally outweigh the theoretical or proven risks of use. Once a medically appropriate method is identified the SPR offers critical guidance on safe and effective use important for contraceptive management and service delivery. The major goal for producing these evidence-based recommendations is to help improve access to and strengthen the quality of family planning services worldwide. While these recommendations reflect a rigorous synthesis and interpretation of the best evidence to date and contribute significantly to medical and public health knowledge around the world a number of recommendations in both the MEC and SPR are grounded in limited to no direct evidence. In the absence of direct evidence indirect evidence and expert opinion inform assessments. Each revision of the MEC and SPR offers an opportunity to identify current knowledge gaps and promote research necessary to continually strengthen the guidelines. As part of the most recent revision of these guidelines a Guideline Development Group convened in March and September 2014 to generate updated recommendations. During these meetings we identified a number of key research questions for a variety of topics discussed during the technical consultations. The full list of research gaps is included in Table 1 not further prioritized. However we present three important topics of global relevance to national programs and policies in greater detail: (a) intrauterine device (IUD) initiation among women at high risk for sexually transmitted infections (STIs); (b) bidirectional drug-drug interactions with use of hormonal contraception (HC) and antiretroviral therapy (ART); and (c) initiation of progestogen-containing contraception following use of ulipristal acetate (UPA) emergency contraception. Each section presents some background on the public health importance of the topic and discusses the limitations of existing data and considerations for future rigorous research. [Excerpts].