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ObjectiveTo assess the relationship of adherence and pregnancy in participants using an estetrol and drospirenone combined oral contraceptive.MethodsWe performed a secondary analysis for which we pooled data from two parallel, multicenter, phase 3 trials (United States and Canada, Europe and Russia) that enrolled participants 16-50 years of age to receive estetrol 15 mg and drospirenone 3 mg in a 24 hormone and four placebo pills regimen for up to 13 cycles. Participants reported pill intake, sexual intercourse, and other contraceptive use on paper diaries. We limited this efficacy analysis to at-risk cycles (one or more reported acts of intercourse and no other contraceptive use) in participants 16-35 years of age at screening. We excluded cycles with other contraceptive use unless pregnancy occurred in that cycle. We assessed primarily the relationship between number of pills not taken per cycle and pregnancies and, secondarily, when pregnancies occurred during product use with a test for trend and χ 2 analyses as appropriate.ResultsAmong 2,837 participants in this analysis, 31 on-treatment pregnancies occurred during 26,455 at-risk cycles. Pregnancies occurred in 0.09%, 0.25%, 0.83%, and 1.6% of cycles in which participants reported they took all hormone pills (n=25,613 cycles) or did not take one (n=405 cycles), two (n=121 cycles), and more than two (n=314 cycles) hormone-containing pills, respectively ( P

ObjectiveTo describe experiences with abortion counseling and access in patients with lethal or life-limiting fetal diagnoses in Texas after enactment of Senate Bill 8 (SB8).MethodsIn this qualitative study, we interviewed patients who obtained abortions after enactment of SB8, using semi-structured interviews to explore how restrictions affected abortion care. Two researchers coded all transcripts using an inductive technique and analyzed themes in an iterative approach.ResultsWe interviewed 16 participants who reported gestational durations from 13 to 29 weeks at the time of abortion. Participants described loss of the therapeutic patient-physician relationship and feelings of isolation while pursuing abortion due to the limitations imposed by SB8. For example, participants felt there was a physician "gag rule" regarding abortion ("the unspoken word of termination"), resulting in the need to find information about pregnancy options outside of the medical community and further highlighting the privilege of financial resources necessary to obtain an abortion on their own. Participants also expressed fears regarding confidentiality with their support systems and clinicians ("I would joke around and say, well don't sue me, but halfway mean it") and personal safety when self-referring for abortion ("…am I making the right choice on where I need to go? Is it safe?").ConclusionAbortion restrictions and bans such as SB8 erode the patient-physician relationship, evoking fear and safety concerns during a vulnerable time for those undergoing abortion for lethal or life-limiting fetal diagnoses. They force patients to shoulder the significant burden of understanding pregnancy options and navigating the process of abortion alone, which is likely to have greater effects on those with fewer resources.

ObjectiveTo evaluate the bleeding patterns of a new combined oral contraceptive containing estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg in a 24/4-day regimen.Study designWe pooled bleeding data from two parallel, open-label, 13-cycle phase 3 trials that enrolled participants 16 to 50 years old with body mass index (BMI) ≤35 kg/m2. Participants reported vaginal bleeding/spotting in daily diaries. For this bleeding analysis, we included participants with at least one evaluable cycle. We calculated mean frequencies of scheduled and unscheduled bleeding/spotting episodes and median duration of bleeding/spotting episodes, and assessed associations between treatment compliance, BMI and recent hormonal contraceptive use on bleeding/spotting outcomes.ResultsWe included 3409 participants with 33,815 cycles. Scheduled bleeding/spotting occurred in 87.2% to 90.4% of participants/cycle, with a median duration of 4 to 5 days. Unscheduled bleeding/spotting decreased from 27.1% in Cycle 1 to 20.6% in Cycle 2 to ≤17.5% from Cycle 5 onwards. Most (66.5%) unscheduled bleeding/spotting episodes were spotting-only. Between 5.8% and 7.8% of users/cycle experienced absence of any scheduled or unscheduled bleeding/spotting. Missing one or more active pills resulted in a higher occurrence of unscheduled bleeding/spotting (adjusted odds ratio [aOR] 2.13 [95% confidence interval 1.68-2.70]) and absence of scheduled bleeding/spotting (aOR 2.36 [1.82-3.07]). Participants with a BMI ≥30 kg/m2 reported more absence of scheduled bleeding/spotting (aOR 1.68 [1.37-2.05]). Switchers and starters reported similar frequencies of unscheduled bleeding/spotting (aOR 0.94 [0.83-1.07]) and absence of scheduled bleeding/spotting (aOR 1.00 [0.85-1.19]). Three percent of participants discontinued for a bleeding-related adverse event.ConclusionE4/DRSP use results in a predictable bleeding pattern with limited unscheduled bleeding/spotting. Noncompliance and BMI affect bleeding patterns.Implications statementMost estetrol/drospirenone users experience a predictable and regular bleeding pattern. Providers can educate patients about the expected bleeding patterns and should advise users that they may infrequently experience no scheduled bleeding/spotting. This information may improve user acceptability and continuation of this new oral contraceptive.

Objective To assess efficacy, cycle control, and safety of an oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. Study design Women aged 16 to 50 years with a body mass index ≤35 kg/m2 enrolled in this multicenter, open-label, 13-cycle, phase 3 trial evaluating E4/DRSP in a 24-active/4-placebo regimen. Follow-up was scheduled at Cycles 2, 4, 7, and 10 and within 3 weeks of completing Cycle 13. Participants used daily diaries to record pill use and vaginal bleeding. We evaluated efficacy outcomes in women 16 to 35 years and bleeding patterns and safety (adverse events [AEs]) in all participants. We assessed overall and method-failure pregnancy rates using the Pearl index (PI) and life-table analysis. Scheduled bleeding included spotting or bleeding starting during the 4-day placebo period or first 3 days of the next cycle. Results We enrolled 1864 women of whom 1674 were 16 to 35 years. Women 16 to 35 years had a PI of 2.65 (95% CI 1.73–3.88), method-failure PI of 1.43 (95% CI 0.7–2.39) and 13-cycle life-table pregnancy rate of 2.1%. Scheduled bleeding occurred in 82.9% to 87.0% of women per cycle; median duration was 4.5 days. Unscheduled bleeding decreased from 30.3% in Cycle 1 to 21.3% to 22.1% during Cycles 2 to 4 and remained stable (15.5% to 19.2%) thereafter. The most frequently reported AEs were headache (5.0%) and metrorrhagia (4.6%). One-hundred thirty-two (7.1%) women discontinued the study early for an AE, most commonly for metrorrhagia (0.9%) and menorrhagia (0.8%). No thromboembolic events occurred. Conclusion E4/DRSP is an effective oral contraceptive with a predictable bleeding pattern for most women and low AE rates. Implications statement A new oral contraceptive with a novel estrogen, estetrol, combined with drospirenone has efficacy and safety within the range of other available oral contraceptives. Large phase 4 studies will be needed to confirm if this combination is associated with an improved adverse event profile or lower thrombosis risk.

BackgroundPostpartum contraception counseling and method use vary widely among patients who had a preterm birth. We performed this study to explore what issues and concerns individuals with preterm infants requiring intensive care describe as influencing their postpartum contraceptive choices.MethodsWe conducted a qualitative study using semi-structured interviews with participants who gave birth to a singleton preterm infant admitted to the neonatal intensive care unit (NICU). We explored pregnancy, childbirth, postpartum care, and NICU experiences, as well as future reproductive plans and postpartum contraceptive choices. Two coders used a constant-comparative approach to code transcripts and identify themes.ResultsWe interviewed 26 participants: 4 (15%) gave birth at less than 26, 6 (23%) at 26 to 27 6/7, 8 (31%) at 28 to 31 6/7, and 8 (31%) at 32 to 36 6/7weeks of gestation. We identified three main themes related to future pregnancy plans and contraception choice. First, participants frequently described their preterm birth and their infants' NICU hospitalization as traumatic experiences that affected plans for future pregnancies. The loss of control in predicting or preventing a future preterm birth and uncertainty about their premature child's future medical needs resulted in participants wanting to avoid going through the same experience with another child. Second, participants chose contraception based on previous personal experiences, desired method features, and advice from others. Last, having a preterm birth did not result in any ambivalence among those who desired permanent contraception.ConclusionsPreterm birth influences future pregnancy plans. When discussing reproductive goals with patients, clinicians should be aware of potential trauma associated with a premature birth, assess for whether patients want to discuss contraception, and center the conversation around individual needs if patients do desire contraceptive counseling.

ObjectiveTo evaluate the cervical mucus effects of a norgestrel 0.075 mg progestin-only contraceptive pill over a 28-day cycle.Study designWe recruited persons ages 18 to 35 with normal cycles at 2 US academic medical centers. Participants took norgestrel 0.075 mg daily for 28 days at the same time (within a 3 hour window) daily, recorded through a text-message based e-diary. We extracted cervical mucus using a standardized aspiration technique on the day of pill initiation and then at least every 3 to 4 days over the cycle. We monitored subjects for follicular activity with transvaginal ultrasound examination and blood sampling for ovarian hormones and gonadotropins at each visit. We assessed cervical mucus scoring using a 4-category/12-point modified Insler scale (score ≥9 [favoring fertility], 5-8 [intermediate], and ≤4 [unfavorable to fertility]). We stratified cervical mucus scores by serum estradiol levels and ovulatory status based on a modified Hoogland score.ResultsExcluding enrollment, we collected and evaluated 413 mucus samples from 51 participants. Participants had a median mucus score of 0 (Interquartile Range 0, 2); most had scores ≤4 (samples=385, 93%) and none had a score ≥9 favoring fertility. Seventeen (33%) participants ovulated, of which 14 (82%) had unfavorable mucus scores (≤4) at the time of ovulation and 3 (18%) had intermediate scores (5-8).ConclusionsNorgestrel 0.075 mg daily prevents mucus changes that favor fertility, even during ovulatory cycles.ImplicationsDaily administration of norgestrel 0.075 mg over an initial 28-day cycle did not result in fertile cervical mucus. Although approximately one-third of users ovulated in this first cycle of pill use, contraceptive efficacy may be maintained by mucus effects.

ObjectivesTo estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill.Study designIn a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI

Purpose of Review In this review, we discuss the efficacy, safety, and benefits of four new contraceptive products available in the USA, specifically Annovera, Phexxi, Slynd, and Twirla. Recent Findings Annovera is a vaginal ring releasing ethinyl estradiol and segesterone acetate that can be used for up to one year (13 cycles), offering patients an effective, user-controlled option that may improve contraceptive access for those in low-resource settings or those with barriers to retrieving monthly prescriptions; however, given limited efficacy and safety data in people with body mass index (BMI) > 29 kg/m2, clinicians may consider whether Annovera is an appropriate contraceptive method for obese patients if there are other acceptable alternatives. Phexxi prescription-only vaginal gel is a user-controlled, non-hormonal, on-demand contraceptive method that represents a novel addition to the market with its additional uses as a personal lubricant and as a potential microbicide for urogenital infection prevention. Slynd, a drospirenone-only pill, provides more flexibility for delayed or missed pills while maintaining efficacy and a more favorable bleeding profile compared with previously available progestin-only pills. Lastly, Twirla is a transdermal patch releasing ethinyl estradiol and levonorgestrel that offers users an additional option for a user-controlled, combined hormonal contraceptive method without daily dosing; however, prescription is limited to patients with BMI 2 due to decreased efficacy and VTE events in people with obesity. Summary The addition of these products expands the available options for pregnancy prevention to address unmet contraceptive needs.

Optimal birth spacing is essential to the health of mothers and children. Return of menses and fecundity are affected by lactation (exclusivity and duration) and maternal energy balance. Lactation Amenorrhea Method (LAM) is a highly effective, temporary method of contraception. The Centers for Disease Control and Prevention and World Health Organization offer guidance regarding the relative efficacy of the variety of available methods of family planning.

ObjectiveDescribe the implementation of a preoperative telemedicine program at a Northern California hospital-based center for abortion procedures requiring cervical preparation.Study designWe implemented a pilot program using telemedicine for preoperative visits for patients needing cervical preparation prior to an abortion procedure from 12 to 18 weeks. We required ultrasonography for gestational age documentation in addition to placental localization in patients with a prior cesarean delivery. We prescribed misoprostol for cervical preparation for patients undergoing the telemedicine preoperative visit; in-person preoperative visits typically involve placement of osmotic dilators. Secondarily, we surveyed patients who had telemedicine and in-person preoperative visits to compare their preoperative experiences.ResultsImplementation required 8 months of multidisciplinary meetings. From March 2018 through March 2019, we received 200 abortion referrals at 12 to 18 weeks gestation. Of these 200 patients, 119 did not meet telemedicine eligibility criteria, most commonly due to inability to obtain required ultrasonography (n=89 [75%]). Of the remaining 81 patients, 43 scheduled telemedicine visits of which 41 initiated and 38 (88%) completed the visits. Twenty-one (55%) telemedicine encounters had no or minor technical difficulties. Thirty-one of 34 (91%) telemedicine and 91 of 108 (84%) in-person visit patients expressed high satisfaction with their preoperative appointment (p=0.4); none reported dissatisfaction. Patients chose the telemedicine visit primarily for convenience and transportation concerns.ConclusionA multidisciplinary team is essential for the successful implementation of a preoperative telemedicine program for procedural abortion care. Patients reported high satisfaction and reduced logistical burdens with the telemedicine option.ImplicationsTelemedicine preoperative visits for abortion procedures at 12 to 18 weeks gestation may improve access to abortion care, reduce patient burdens, and provide an alternative encounter option which may improve the patient experience.

ObjectivesTo describe practice patterns of an integrated complex family planning-pediatric hematology oncology clinic for patients with blood disorders STUDY DESIGN: We retrospectively evaluated the outcomes of patients who had an initial consultation for blood disorders impacting menstrual bleeding in an integrated complex family planning-pediatric hematology oncology clinic from October 2015 to September 2020. We reviewed all charts to extract medical and gynecologic history, blood disorder diagnosis, hormonal treatment prior to and following initial consultation, subsequent visits to the integrated clinic, and hormonal treatment up to 24 months after initial consultation.ResultsWe saw 47 patients; their most common blood disorder diagnosis was protein defect (14 of 47, 30%). Most patients (30 of 47, 64%) were not using any hormonal treatment prior to their initial consultation. After the initial consultation, 26 (55%) elected to start, change, or discontinue hormonal treatment for abnormal menstrual bleeding, the most common treatment being combined hormonal contraception (CHC, 22 of 47, 47%), alone or as dual therapy. Over the study duration, 36 patients (77%) initiated, changed, or discontinued their hormone treatment, 22 (61%) of whom changed their treatment plan more than once. CHC usage decreased from 19 of 47 (40%) to 8 of 37 (22%) and hormonal device usage, particularly the implant, increased from 9 of 47 (19%) to 11 of 37 (30%) over the 24 months from initial consultation.ConclusionMost patients in an integrated complex family planning-pediatric hematology oncology clinic will change their menstrual bleeding hormone treatment with initial consultation, although management may require multiple changes. The most common treatment 24 months following the initial consultation was hormonal devices.ImplicationsPatients with blood disorders affecting menstrual bleeding have complex needs that could be addressed by an integrated complex family planning-pediatric hematology oncology clinic. Most patients require multiple changes in treatment to achieve adequate control of their bleeding, and patients were more likely to choose hormonal devices for management over time.

Objectives To assess referral center outcomes with removal of difficult or nonpalpable contraceptive implants using high-frequency point-of-care ultrasonography. Study Design We present a case series examining patients referred to our specialty center from January 2019 through September 2020 for difficult or nonpalpable implant removal. Results Of the 54 referrals, 6 had palpable implants and 48 required ultrasonography. We localized 46 (96%) implants in-office, including 13 located subfascially; 2 Implanon implants could not be localized. We successfully completed 50 (96%) of 52 attempted in-office removals, including 12 (92%) subfascial implants. Conclusion High-frequency point-of-care ultrasonography can effectively localize nonpalpable contraceptive implants leading to successful in-office removal. Implications Specialists can use high-frequency point-of-care ultrasonography to localize nonpalpable implants without formal radiology scans and skilled technologists, optimizing patient time and convenience. However, the probe is expensive, and providers may need to consider this cost in the context of reimbursement for these highly specialized procedures.

ObjectivesTo evaluate mifepristone impact on osmotic dilator placement and procedural outcomes when given 18 to 24 hours before dilator placement for dilation and evacuation (D&E) at 18 weeks 0 days to 23 weeks 6 days gestation.Study designWe performed a randomized, double-blind, placebo-controlled trial from April 2019 through February 2021, enrolling participants undergoing osmotic dilator (Dilapan) placement for a planned, next-day D&E. Participants took mifepristone 200 mg or placebo orally 18 to 24 hours before dilator placement. We used a gestational age-based protocol for minimum number of dilators. Our primary outcome was the proportion of participants for whom 2 or more additional dilators could be placed compared to the minimum gestational age-based standard. We secondarily evaluated cervical dilation after dilator removal in the operating room, subjective procedure ease, and complication rates (cervical laceration, uterine perforation, blood transfusion, infection, hospitalization, or extramural delivery).ResultsOf the planned 66 participants, we enrolled 44 (stopped due to coronavirus disease 2019-related obstacles), and 41 (19 mifepristone; 22 placebo) completed the study. We placed 2 or more additional dilators compared to standard in 7 (36.8%) and 3 (13.6%) participants after mifepristone and placebo, respectively (p=0.14). We measured greater median initial cervical dilation in the mifepristone (3.2 cm[2.6-3.6]) compared to placebo (2.6 cm[2.2-3.0]) group, p=0.03. Surgeon's perception of procedure being "easy" (8/19[42.1] vs 9/22[40.9], respectively, p=1.00) and complication rate (3/19[15.8%] vs 3/22[13.6], respectively, p=1.00) did not differ.ConclusionOur underpowered study did not demonstrate a difference in cervical dilator placement, but mifepristone 18 to 24 hours prior to dilators increases cervical dilation without increasing complications.ImplicationsMifepristone 18 to 24 hours prior to cervical dilator placement may be a useful adjunct to cervical dilators based on increased cervical dilation at time of procedure; however, logistical barriers, such as an additional visit, may preclude routine adoption without definite clinical benefit.

ObjectiveTo evaluate the proportion of 12-month contraceptive pill, patch, and ring prescriptions before and after an institution-wide change of default electronic medical record facility orders to dispensing 12-month supply.Study designThis retrospective pre-post study compares outpatient contraception prescriptions from August 10, 2019 through April 9, 2020 obtained from our institutional electronic medical record prescription database. On December 10, 2019, we facilitated a change in the default orders for dispensing self-administered hormonal contraceptives from one-month to 12-months. We evaluated the primary outcome of 12-month supply prescriptions during the four months before and after the change. We also compared 12-month supply prescriptions for pills, patch, and ring by prescriber specialty and location.ResultsThe dataset included 4897 distinct evaluable prescriptions for the pill, patch, or ring, with an overall increase in 12-month prescriptions from 260/2437 (10.7%) to 669/2460 (27.2%) after the order change (p&nbsp

ObjectiveTo evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200mcg/day and segesterone acetate (SA) 200mcg/day to identify a dose that avoids hypoestrogenism.Study designWe conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.ResultsSixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22)mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100mcg/day groups were 40pg/mL throughout 30days; E2 concentrations were 37pg/mL (range 28-62pg/mL) on days 88-90 (n=11). Among the E2 200mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days.ConclusionsEstradiol concentrations with rings releasing E2 200mcg/day and SA 200mcg/day avoid hypoestrogenism over 30-day use.ImplicationsA 90-day contraceptive vaginal ring releasing estradiol 200mcg/day and segesterone acetate 200mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.

IMPORTANCE: Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen. OBJECTIVE: To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States. DESIGN, SETTING, AND PARTICIPANTS: This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019. INTERVENTIONS: Mifepristone pretreatment plus misoprostol administration vs misoprostol alone. MAIN OUTCOMES AND MEASURES: Costs in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated. RESULTS: Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815–0.0825] vs 0.0806 [95% CI, 0.0800–0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, −$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, −$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingnessto-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively. CONCLUSIONS AND RELEVANCE: This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02012491

Objectives To determine progestin-only pill (POP) use at 3 and 6 months postpartum among women who chose POPs at the postpartum visit. Study Design Secondary data analysis of a prospective observational study with telephone interviews at 3 and 6 months postpartum to assess contraceptive use. Results Of 440 women who attended the postpartum visit, 92 (20.9%) chose POPs. Current POP use was 44/84 (52.4%) at 3 months, 33/76 (43.4%) at 6 months, and 32/76 (42.1%) at both 3- and 6-month follow-up assessments. Conclusion About half of women who plan POP use at the postpartum visit are not using this method at 3 months after delivery. Implications About half of women with a prescription for progestin-only pills will be not using this method at 3 months postpartum; further understanding of continued sexual activity and breastfeeding may clarify pregnancy risk for those not reporting modern contraception use during the postpartum period.

Author(s): Creinin, Mitchell D; Hou, Melody Y; Dalton, Laura; Steward, Rachel; Chen, Melissa J | Abstract: ObjectiveTo estimate the efficacy and safety of mifepristone antagonization with high-dose oral progesterone.MethodsWe planned to enroll 40 patients in a double-blind, placebo-controlled, randomized trial. We enrolled patients at 44-63 days of gestation with ultrasound-confirmed gestational cardiac activity who were planning surgical abortion. Participants ingested mifepristone 200 mg and initiated oral progesterone 400 mg or placebo 24 hours later twice daily for 3 days, then once daily until their planned surgical abortion 14-16 days after enrollment. Follow-up visits were scheduled 3±1, 7±1, and 15±1 days after mifepristone intake with ultrasonography and blood testing for human chorionic gonadotropin and progesterone. Participants exited from the study when they had their surgical abortion or earlier for gestational cardiac activity absence, gestational sac expulsion, or medically indicated suction aspiration. We assessed the primary outcome of continued gestational cardiac activity at approximately 2 weeks (15±1 day), side effects after drug ingestion, and safety outcomes including hemorrhage and emergent treatment.ResultsWe enrolled participants from February to July 2019 and stopped enrollment after 12 patients for safety concerns. Mean gestational age was 52.5 days. Two (one per group) voluntarily discontinued 3 days after mifepristone ingestion for subjective symptoms (nausea and vomiting, bleeding). Among the remaining 10 patients (five per group), gestational cardiac activity continued for 2 weeks in four in the progesterone group and two in the placebo group. One patient in the placebo group had no gestational cardiac activity 3 days after mifepristone use. Severe hemorrhage requiring ambulance transport to hospital occurred in three patients; one received progesterone (complete expulsion, no aspiration) and two received placebo (aspiration for both, one required transfusion). We halted enrollment after the third hemorrhage. No other significant side effects were reported.ConclusionWe could not estimate the efficacy of progesterone for mifepristone antagonization due to safety concerns when mifepristone is administered without subsequent prostaglandin analogue treatment. Patients in early pregnancy who use only mifepristone may be at high risk of significant hemorrhage.Clinical trial registrationClinicalTrials.gov, NCT03774745.

ObjectiveTo evaluate if gabapentin 600 mg reduces pain after osmotic dilator placement the day before a dilation and evacuation (D&E) procedure.Study designWe conducted a double-blind, placebo-controlled, randomized (stratified by vaginal parity) trial among women undergoing osmotic dilator placement before D&E at 15-23 5/7 weeks gestation. Subjects received gabapentin 600 mg or placebo 30 min before dilator placement, with re-dosing 8 h later. We assessed pain after dilator placement using a numeric rating scale (NRS; scale 0-10) at 5 min, 2, 4, and 8 h, and at presentation for D&E. The primary outcome was median NRS pain score change from baseline to 8 h after dilator placement. Secondary outcomes included gabapentin-related side effects and analgesic use.ResultsOf 121 randomized women, we excluded three subjects (allergic reaction [placebo], randomization error, no NRS data), leaving 60 gabapentin and 58 placebo subjects. Of 110 (93%) women who provided 8-hour data, median pain score changes from baseline did not differ between gabapentin and placebo groups overall (2 vs. 2.5, p = 0.52), in vaginally nulliparous women (2 vs. 4, p = 0.10) or in parous women (2 vs. 1.5, p = 0.37). We found no statistically significant differences in median pain score change from baseline to any timepoint overall or when stratified by parity. Beginning at 2 h after dilator placement, more gabapentin than placebo users experienced dizziness (29/53[55%] vs. 11/53[21%], p = 0.001) and tiredness (34/54[63%] vs. 17/54[31%], p = 0.002). The proportion of women using narcotics did not differ between gabapentin (35/60[58%]) or placebo (40/58[69%]) users (p = 0.26).ConclusionsGabapentin does not reduce pain with overnight osmotic dilator placement prior to D&E and causes drug-related side effects.Implications statementWomen experience pain, mostly mild to moderate, with overnight cervical dilator placement at 15-23 5/7 weeks gestation. About 2/3 of women will use a limited quantity of narcotics if provided. Gabapentin does not decrease the pain with or following dilator placement and does not decrease narcotic use.

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.

© 2017 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved. 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

© 2018 Elsevier Inc. 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.

Persistent trophoblast after ectopic pregnancy has been demonstrated at the surgical site or as peritoneal implants. A 37-year-old woman (G5P2) experienced persistently low levels of beta-human chorionic gonadotropin (hCG) after surgical treatment for an interstitial pregnancy. Evaluation for persistent trophoblast, gestational trophoblastic neoplasm and heterophilic antibodies was negative. After 15 months without resolution, she elected for hysterectomy. We found four smooth, freely floating avascular cysts intraoperatively; pathological evaluation identified the cysts as trophoblastic tissue. Serum beta-hCG resolved postoperatively and remained negative at 1 year. Our case demonstrates the novel finding of trophoblastic tissue existing as free-floating cysts in the peritoneal cavity. With appropriate suspicion, these cysts can be identified on radiologic investigation and removed laparoscopically.

Objective To evaluate whether scheduling a 2- to 3-week versus 6-week postpartum visit results in higher visit attendance. Study Design We conducted a secondary analysis of a quasi-experimental before–after study to compare postpartum visit attendance after changing routine scheduling of visits from 6 weeks to 2 to 3 weeks after delivery. Secondary outcomes include patient satisfaction and breastfeeding continuation at 3 and 6 months postpartum. We collected postpartum visit information through a chart review and conducted telephonic interviews at 3 and 6 months postpartum to assess satisfaction with visit timing and breastfeeding status. We performed multivariable analyses to assess predictors of visit attendance. Results Women scheduled at 2 to 3 weeks postpartum demonstrated higher visit attendance (90.2%; 95% confidence interval [CI]: 86.6–93.9%) compared with 6 weeks (81.6%; 95% CI: 76.3–86.2%; p Conclusion Scheduling a 2- to 3-week postpartum visit is associated with higher attendance.

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)

© 2018 Objective: We evaluated a novel concept of initiating the etonogestrel implant as a “back-up” method in women who desire using combined oral contraceptives (COC) but want to decrease their risk of unintended pregnancy with a more effective method. Study Design: In this prospective cohort study, we planned to include 20 women as a proof-of-concept. We enrolled both new COC starters and continuing COC users and placed an etonogestrel implant. Participants completed daily bleeding diaries and attended follow-up visits at 1, 3, and 6 months. We assessed implant continuation through six months of study participation and side effects with dual hormonal contraceptive use. Results: Between September and December 2016, we enrolled 10 new starters and 10 current COC users. All participants completed 1-month follow-up, and 18 (90%) subjects completed the 3- and 6-month follow-up assessments. Two current COC users had the implant removed for mood changes before 6 months. At the 6-month follow-up visit, 10 women were using both pills and implant, seven relied on the implant only, and one was using a COC only. Three new starters chose implant removal at end of study participation; one for weight gain and acne, another for mood changes, and one for decreased libido. No subjects discontinued the implant for bleeding complaints. Conclusion: In this proof-of-concept study, women using COCs were willing to initiate the implant as a “back-up” method to improve pregnancy prevention. Most women continued the implant through 6 months and after completing study participation. Implications: Initiating the etonogestrel implant as a “back-up” method may be an option for women who desire more effective pregnancy prevention while using combined oral contraceptive pills for its bleeding profile or non-contraceptive benefits.

OBJECTIVE. The objective of our study was to determine if placental MRI examinations performed for the detection of abnormal placentation earlier than 24 weeks' gestational age (GA) are more or less reliable than examinations performed at a later GA. MATERIALS AND METHODS. Two radiologists blinded to clinical, surgical, and pathologic reports retrospectively and independently reviewed 69 placental MRI examinations for nine imaging signs associated with abnormal placentation. A consensus of the suspicion of abnormal placentation (including accreta, increta, or percreta) was determined using a 5-point (low to high suspicion) Likert scale and compared with pathologic or surgical findings or both. RESULTS. Seventeen placental MRI examinations were performed at GA 14–23 weeks, and 52 placental MRI examinations were performed at GA 24–41 weeks. Reviewer agreement (Cronbach alpha) among the nine imaging signs was 0.86 (95% CI, 0.72–0.92) and 0.92 (95% CI, 0.92–0.94) for MRI examinations at GA 14–23 weeks and GA ...

ObjectiveTo 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 sourcesWe 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 selectionStudies 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 resultsWe 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.ConclusionOutpatient 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.

ObjectiveTo 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 program's initiation and to assess whether other postpartum health behaviors improved during the intervention period.MethodsThis 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.ResultsOf 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

Author(s): Matulich, Melissa Carol; Chen, Melissa Joy; Schimmoeller, Natasha Rita; Hsia, Jennifer K; Uhm, Suji; Creinin, Mitchell D

A multiparous woman aged 34 years with a prior low transverse caesarean delivery presented at 12 weeks gestation for nuchal translucency screening. She had an unremarkable ultrasound study at 8 weeks gestation. Although asymptomatic at her screening, the patient had imaging findings suspicious for a caesarean scar ectopic, including loss of myometrial border between the placenta and uterine serosa on her ultrasound (figure 1A) and MRI examinations (figure 1B). The patient was counselled on her options, including continuing the pregnancy with further interventions at the …

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., 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.

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.

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

Author(s): Chen, Melissa J; Kennedy, Jeffrey; Melo, Juliana; Hou, Melody; Creinin, Mitchell D; Cansino, Catherine

Medical abortion with mifepristone and misoprostol is an effective and safe option for early pregnancy termination. Mifepristone is a progesterone-receptor modulator that binds competitively to progesterone receptors; therefore, mifepristone could be less effective when administered in the setting of progestin-based contraception use. The present study reports a successful medical abortion following recent use of depot medroxyprogesterone acetate (DMPA) (Depo-Provera Contraceptive Injection; Pfizer, New York, New York, USA), administered at a family planning clinic. The patient gave informed consent for the inclusion of their data in the present study and, as a case report, the present study did not require institutional review board approval. This article is protected by copyright. All rights reserved.