Melissa J. Chen

Mifepristone With Buccal Misoprostol for Medical Abortion A Systematic Review

OBJECTIVE: To summarize clinical outcomes and adverse effects of medical abortion regimens consisting of mifepristone followed by buccal misoprostol in pregnancies through 70 days of gestation. DATA SOURCES: We used PubMed, ClinicalTrials.gov, and reference lists from published reports to identify relevant studies published between November 2005 and January 2015 using the search terms “mifepristone and medical abortion” and “buccal and misoprostol.” METHODS OF STUDY SELECTION: Studies were included if they presented clinical outcomes of medical abortion using mifepristone and buccal misoprostol through 70 days of gestation. Studies with duplicate data were excluded. TABULATION, INTEGRATION, AND RESULTS: We included 20 studies with a total of 33,846 women through 70 days of gestation. We abstracted efficacy and ongoing pregnancy rates as an overall rate and by gestational age in days in reference to completed weeks (eg, 49 days or less, 50–56 days, 57–63 days, 64–70 days) and adverse effects when reported. The overall efficacy of mifepristone followed by buccal misoprostol is 96.7% (95% confidence interval [CI] 96.5–96.8%) and the continuing pregnancy rate is 0.8% (95% CI 0.7–0.9%) in approximately 33,000 pregnancies through 63 days of gestation. Only 332 women with pregnancies between 64 and 70 days of gestation are reported in the literature with an overall efficacy of 93.1% (95% CI 89.6–95.5%) and a continuing pregnancy rate of 2.9% (95% CI 1.4–5.7%). Currently available data suggest that regimens with a 24-hour time interval between mifepristone and buccal misoprostol administration are slightly less effective than those with a 24- to 48-hour interval. Rates of surgical evacuation for reasons other than ongoing pregnancy range from 1.8% to 4.2%. Severe adverse events like blood transfusion (0.03–0.6%) and hospitalization (0.04–0.9%) are uncommon. CONCLUSION: Outpatient medical abortion regimens with mifepristone followed in 24–48 hours by buccal misoprostol are highly effective for pregnancy termination through 63 days of gestation. More data are needed to evaluate clinical outcomes with regimens containing mifepristone followed in 24 hours by buccal misoprostol and in pregnancies beyond 63 days of gestation.

The use of psychosocial stress scales in preterm birth research

Psychosocial stress has been identified as a potential risk factor for preterm birth. However, an association has not been found consistently, and a consensus on the extent to which stress and preterm birth are linked is still lacking. A literature search was performed with a combination of keywords and MeSH terms to detect studies of psychosocial stress and preterm birth. Studies were included in the review if psychosocial stress was measured with a standardized, validated instrument and if the outcomes included either preterm birth or low birthweight. Within the 138 studies that met inclusion criteria, 85 different instruments were used. Measures that had been designed specifically for pregnancy were used infrequently, although scales were sometimes modified for the pregnant population. The many different measures that have been used may be a factor that accounts for the inconsistent associations that have been observed.

Using a Patient Navigator to Improve Postpartum Care in an Urban Women's Health Clinic.

OBJECTIVE To estimate whether postpartum visit attendance was improved in women exposed to a postpartum patient navigation program compared with those who received care immediately before the programs initiation and to assess whether other postpartum health behaviors improved during the intervention period. METHODS This is a prospective observational study of women enrolled in a patient navigation program compared with women receiving care before the program. Navigating New Motherhood was a postpartum patient navigation program for adult, English-speaking women receiving prenatal care at a Medicaid-based university clinic. In 2015, Navigating New Motherhood introduced a clinic-level change in which a navigator was hired and assumed supportive and logistic responsibilities for enrolled patients between delivery and postpartum visit completion. We compared medical record data from women who enrolled in Navigating New Motherhood with those of women receiving care in the same clinic for 1 year immediately before Navigating New Motherhood. The primary outcome was postpartum visit attendance. Secondary outcomes included World Health Organization (WHO) Tier 1 or 2 contraception uptake and other health services measures. We conducted bivariable and multivariable analyses. RESULTS Of the 225 women approached for Navigating New Motherhood participation after program initiation, 96.9% (n=218) enrolled; these women were compared with 256 women in the historical cohort. Most women in both groups were racial or ethnic minorities and all had Medicaid insurance. There were no important differences in demographic, clinical, or health service characteristics between groups, although women in Navigating New Motherhood were more likely to transfer into the clinic for prenatal care and to deliver neonates admitted to the neonatal intensive care unit. The primary outcome, return for postpartum care, was more common among women in Navigating New Motherhood (88.1% compared with 70.3%, P<.001), a difference that persisted after adjustment for potential confounding factors (adjusted odds ratio [OR] 3.57, 95% confidence interval [CI] 2.11-6.04). Women in Navigating New Motherhood also were more likely to receive a WHO Tier 1 or 2 contraceptive method (adjusted OR 1.56, 95% CI 1.02-2.38), postpartum depression screening (adjusted OR 2.82, 95% CI 1.79-4.43), and influenza (adjusted OR 2.10, 95% CI 1.38-3.19) and human papillomavirus vaccination (adjusted OR 2.33, 95% CI 1.25-4.33). CONCLUSION Implementation of a postpartum navigation program was associated with improved retention in routine postpartum care and frequency of contraception uptake, depression screening, and vaccination.

Medical abortion reporting of efficacy: the MARE guidelines

Contraception 94 (2016) 97 – 103 Commentary Medical abortion reporting of efficacy: the MARE guidelines ☆,☆☆ Mitchell D. Creinin ⁎ , Melissa J. Chen Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA Received 20 April 2016; accepted 22 April 2016 1. Introduction This commentary introduces the Medical Abortion Reporting of Efficacy (MARE) guidelines as a supplement to CONSORT [1] and STROBE [2]. The goal of the recommendations is to standardize early medical abortion efficacy reporting to facilitate comparison of outcomes between studies and to enrich the ability for data synthesis from different studies to create evidence-based guidelines. Although the term medical abortion had most commonly referred to the use of abortion-inducing medication for early pregnancy termination without primary surgical intervention, more recently, the phrase has been used to refer to labor induction abortions as well [3,4]. Accordingly, we consider early medical abortion to refer to procedures in the first trimester. Reports of using medical agents to cause early abortion first appeared in the 1950s [5], but the modern era of medical abortion research started in the early 1980s with the discovery of test agents that were ultimately developed into mifepristone. Over the past 30 years, research has evolved, with the use of various drugs including mifepristone, methotrexate, tamoxifen, letrozole and various prostaglandin analogs to induce early abortion [6]. The first drug with a labeled indication for medical abortion, mifepristone, was initially approved in China and France more than two decades ago. The United States Food and Drug Administration approved mifepristone in 2000 for use in combination with the prostaglandin analog misoprostol for abortion through 49 days gestation. Funding: none. Conflicts of Interest: Dr. Chen has no conflicts of interest. Dr. Creinin is a consultant to Danco. ⁎ Corresponding author. Tel.: +1-916-734-6670. E-mail address: mdcreinin@ucdavis.edu (M.D. Creinin). http://dx.doi.org/10.1016/j.contraception.2016.04.013 0010-7824/© 2016 Elsevier Inc. All rights reserved. Over the more than 25 years since mifepristone first became available for women to obtain a medical abortion, researchers have continued to evaluate alternative regimens to improve efficacy and the patient experience. Professional and national organizations now lead the way in promoting the best science by providing evidence-based recommendations for the preferred medical abortion treatment options [6–8]. Although many individual studies are methodologically strong, the heterogeneity of design, conduct and reporting hinders synthesis of data from multiple studies. Importantly, many studies do not stratify outcomes by week of gestation. These issues became evident during data collation for creation of the 2014 Medical Management of First Trimester Abortion Practice Bulletin written collaboratively by the American College of Obstetricians and Gynecologists and the Society of Family Planning [6,7]. More recently, a systematic review including approximately 30,000 patients who received mifepristone and buccal misoprostol found that only 57% had data identifying week of gestation for a stratified evaluation of overall efficacy; only 51% had such information for evaluation of continuing pregnancy [9]. Well-performed and reported research trials provide the basis for evidence-based guidelines and do more than simply inform providers and patients about more cost-effective or therapeutically effective options — they also affect access to care. Methodologically strong research can counter ideologi- cally motivated arguments for legal restrictions on medical abortion regimens and gestational age limits. The medical community can use this evidence to oppose such legislation. Future synthesis of the large body of available data to inform patient care and regulatory policy can be facilitated with the use of guidelines to ensure that publications of original data are presented in a standardized way. We herein present reporting recommendations for early medical abortion as a supplement to the CONSORT guidelines (for

Long-Acting Reversible Contraception Initiation With a 2- to 3-Week Compared With a 6-Week Postpartum Visit.

OBJECTIVE To evaluate whether a department policy changing the scheduling of the postpartum visit from 6 weeks to 2-3 weeks after delivery is associated with higher long-acting reversible contraception initiation at the postpartum visit. METHODS We conducted a quasiexperimental before-after study to evaluate long-acting reversible contraception initiation, specifically an intrauterine device or contraceptive implant, at the postpartum visit between women scheduled for follow-up at 6 weeks (before policy change) and 2-3 weeks after delivery (after policy change). Secondary outcomes included postpartum visit completion, overall contraception initiation at the postpartum visit, overall contraceptive use at 6 months after delivery, and repeat pregnancies by 6 months postpartum. We obtained delivery and postpartum information using the electronic medical record and contacted participants 3 and 6 months after delivery to assess contraception use and repeat pregnancies. RESULTS We enrolled 586 participants between December 2014 and November 2015, of whom 512 women (256 in each cohort) continued to meet eligibility criteria after delivery. Long-acting reversible contraception initiation rates at the postpartum visit were lower in the 2- to 3-week (16.5%, 95% CI 12.2-21.8) compared with the 6-week group (31.1%, 95% CI 25.2-37.7, P<.01), primarily as a result of patient and health care provider preferences for delaying intrauterine device insertion to a later visit. More women completed a scheduled 2- to 3-week postpartum visit (90.2%, 95% CI 86.0-93.3) compared with a 6-week visit (81.6%, 95% CI 76.4-85.9, P<.01). Deferral of any contraception initiation was higher in the 2- to 3-week group (27.3%, 95% CI 21.9-33.4) compared with the 6-week group (15.8%, 95% CI 11.5-21.4, P<.01), but there were no differences in overall contraceptive use patterns at 6 months postpartum. No intrauterine device perforations or expulsions were observed in women who underwent insertion at 2-3 weeks postpartum. Five pregnancies were reported in each cohort by 6 months after delivery. CONCLUSION Scheduling a visit at 2-3 weeks after delivery was not associated with increased long-acting reversible contraception initiation at this visit despite higher postpartum visit attendance.

Use of the world health organization's medical eligibility criteria for contraceptive use guidance in Sub-Saharan African countries: A cross-sectional study

The revised 2015 World Health Organization guidance expanded the recommended contraceptive options available to breastfeeding women during the early postpartum period to include progestogen-only pills and implants, but a substantial number of surveyed country representatives indicated that as yet their national policies did not allow such women to use these methods at that time. Countries may benefit from support to incorporate MEC guidance into national service delivery guidelines. The revised 2015 World Health Organization guidance expanded the recommended contraceptive options available to breastfeeding women during the early postpartum period to include progestogen-only pills and implants, but a substantial number of surveyed country representatives indicated that as yet their national policies did not allow such women to use these methods at that time. Countries may benefit from support to incorporate MEC guidance into national service delivery guidelines. ABSTRACT Given recent updates to the postpartum contraception recommendations in the fifth edition of the Medical Eligibility Criteria for Contraceptive Use (MEC), published by the World Health Organization (WHO), the purpose of this qualitative study was to assess the extent to which national family planning policies in sub-Saharan African countries are in agreement with the WHO MEC, particularly with regard to postpartum contraceptive use. WHO headquarters sent questionnaires to country-level focal points to complete with their Ministry of Health counterparts. Between February and May 2016, 23 of 32 (72%) surveys were completed. All respondents reported that their countries had used the MEC document in the past, with most reporting that they had used the guidance as a reference (n = 20, 87%), for training purposes (n = 19, 83%), to change clinical practices (n = 17, 74%), and to develop national policies (n = 16, 70%). While many respondents (16, 70%) indicated their countries already include immediate postpartum intrauterine device insertion among breastfeeding women in their family planning policies, few reported currently allowing use of progestogen-only pills (n = 8, 35%) or implants (n = 8, 35%) during the immediate postpartum period (i.e., less than 48 hours after delivery) for breastfeeding women. A higher percentage of respondents indicated their countries allowed breastfeeding women the option of progestogen-only pills (n = 16, 70%) and implants (n = 13, 57%) between 48 hours and 6 weeks postpartum. Findings from this baseline assessment suggest that many countries may benefit from training and policy formulation support to adapt both new WHO MEC updates as well as existing recommendations from previous MEC revisions into national family planning guidelines.

Comparing office and telephone follow-up after medical abortion ☆ ☆☆

OBJECTIVES Compare proportion lost to follow-up, successful abortion, and staff effort in women who choose office or telephone-based follow-up evaluation for medical abortion at a teaching institution. STUDY DESIGN We performed a chart review of all medical abortions provided in the first three years of service provision. Women receiving mifepristone and misoprostol could choose office follow-up with an ultrasound evaluation one to two weeks after mifepristone or telephone follow-up with a scheduled telephone interview at one week post abortion and a second telephone call at four weeks to review the results of a home urine pregnancy test. RESULTS Of the 176 medical abortion patients, 105 (59.7%) chose office follow-up and 71 (40.3%) chose telephone follow-up. Office evaluation patients had higher rates of completing all required follow-up compared to telephone follow-up patients (94.3% vs 84.5%, respectively, p=.04), but proportion lost to follow-up was similar in both groups (4.8% vs 5.6%, respectively, p=1.0). Medical abortion efficacy was 94.0% and 92.5% in women who chose office and telephone follow-up, respectively. We detected two (1.2%) ongoing pregnancies, both in the office group. Staff rescheduled 15.0% of appointments in the office group. For the telephone follow-up cohort, staff made more than one phone call to 43.9% and 69.4% of women at one week and four weeks, respectively. CONCLUSIONS Proportion lost to follow-up is low in women who have the option of office or telephone follow-up after medical abortion. Women who choose telephone-based evaluation compared to office follow-up may require more staff effort for rescheduling of contact, but overall outcomes are similar. IMPLICATIONS Although women who choose telephone evaluation may require more rescheduling of contact as compared to office follow-up, having alternative follow-up options may decrease the proportion of women who are lost to follow-up.

Development, updates, and future directions of the World Health Organization Selected Practice Recommendations for Contraceptive Use

Correct and consistent use of contraception decreases the risk of unintended pregnancy; yet outdated policies or practices can delay initiation or hinder continuation of contraceptive methods. To promote the quality of and access to family planning services WHO created a series of evidence-based guidance documents for family planning known as WHOs Four Cornerstones of Family Planning Guidance. The Medical eligibility criteria for contraceptive use (MEC) first published in 1996 provides guidance on the safety of various contraceptive methods in users with specific health conditions or characteristics (i.e. who can use a contraceptive method safely). The Selected practice recommendations for contraceptive use (SPR) is the second cornerstone outlining how to safely and effectively use contraceptive methods. These two documents can serve as a reference for policymakers and program managers as they develop their own national family planning policies in the context of local needs values and resources. The two other cornerstone documents -- the Decision making tool for family planning clients and providers and Family planning: a global handbook for providers -- provide guidance to healthcare providers for applying these recommendations in practice. Between 2013 and 2014 WHO convened a Guideline Development Group (GDG) to review and update the MEC and SPR in line with current evidence. As a result of these meetings the fifth edition of the MEC was published in 2015 and the third edition of the SPR will be released on December 14 2016. The purpose of the present report is to describe the methods used to develop the SPR recommendations research gaps identified during the guideline development process and future directions for the dissemination and implementation of the SPR among policymakers and family planning program managers worldwide. (excerpt)

Successful completion of total and partial salpingectomy at the time of cesarean delivery

OBJECTIVE Evaluate completion of partial or total salpingectomy during Cesarean delivery based on intended procedure. STUDY DESIGN We conducted a retrospective study of women who had a permanent contraception procedure during Cesarean delivery at an urban, academic hospital from November 2015 through April 2017. We reviewed all charts of women who had a Cesarean delivery to identify those who underwent concomitant tubal surgery, including both completed and attempted procedures. We compared demographic, medical, and obstetric characteristics of participants by planned and completed method using univariate analysis. RESULTS We identified 122 women who underwent Cesarean delivery with planned concurrent permanent contraception procedure. Thirty-two (26.2%) women preferred partial salpingectomy and 90 (73.8%) preferred total salpingectomy. All women who desired partial salpingectomy had the procedure performed. However, 17 (18.9%) women desiring total salpingectomy could not have the procedure performed bilaterally: nine underwent a mixed procedure and seven underwent bilateral partial salpingectomy because of adhesions, engorged vasculature, or unspecified reasons. One woman had significant adhesive disease preventing any procedure. Among women who planned a total salpingectomy, having ≥3 Cesarean deliveries was the only factor associated with needing an alternative procedure (P=.04). CONCLUSION As interest in total salpingectomy for permanent contraception increases, surgeons should counsel women who are interested in total salpingectomy at time of Cesarean delivery that adhesions and tubal proximity to adjacent vessels may preclude completion of bilateral tubal removal and discuss alternative options prior to surgery. IMPLICATIONS Interest in bilateral total salpingectomy for permanent contraception at the time of Cesarean delivery is increasing; accordingly, surgeons should counsel patients that adhesions and proximity to large vessels may preclude completion of bilateral total salpingectomy, especially in women who have had multiple prior Cesarean deliveries.

Controversies in family planning: persistently elevated serum human chorionic gonadotropin levels after aspiration abortion

Low but rising serum human chorionic gonadotropin (hCG) levels occur infrequently after an induced abortion. Because this scenario rarely occurs after suction aspiration, clinicians may have higher suspicion for an uncommon diagnosis. The differential diagnosis includes both common and uncommon diagnoses, such as incomplete abortion, heterotopic or ectopic pregnancy, a new intrauterine pregnancy and gestational trophoblastic neoplasia. The etiology of this presentation may be unclear, especially in the absence of abnormal bleeding or pain which would suggest incomplete abortion, or when significant time has passed since the procedure. We describe two cases of an uncommon presentation of retained products of conception after aspiration abortion in which hCG levels were low but rising.