Awareness of the Maternal Health Benefits of Lactation Among U.S. Pregnant Individuals.

INTRODUCTION: We assessed awareness of the maternal health benefits of lactation among a sample of nulliparous pregnant individuals in the United States, identified variables associated with awareness of these benefits, and examined whether awareness of these benefits impacts breastfeeding attitudes or intentions. METHODS: We administered a web-based survey to nulliparous U.S.-born individuals carrying a singleton gestation of at least 28 weeks. We assessed awareness of the maternal health benefits of lactation using 10 items to create a summative score. We examined variation in awareness of these benefits by demographic characteristics, health insurance, and personal or family health history and used multivariable models to estimate associations between awareness of the maternal health benefits of lactation and breastfeeding intentions. RESULTS: Of the 675 individuals invited to complete surveys, 451 (67%) responded. Only 50% were aware that breastfeeding lowers maternal risk of breast cancer; fewer were aware that breastfeeding lowers the risk of ovarian cancer (35%), diabetes (27%), and hypertension and heart disease (26%). Awareness of the maternal benefits of lactation did not vary by age or race/ethnicity. However, significant regional variation was noted. In multivariable models, scores of awareness of the maternal health benefits of breastfeeding were significantly associated with intentions to breastfeed for at least 12 months (adjusted odds ratio, 1.23; 95% confidence interval, 1.11, 1.37). CONCLUSIONS: Efforts to increase awareness of the maternal health benefits of lactation are still needed. Increasing awareness of the maternal health benefits of lactation may strengthen intentions to breastfeed as recommended.

Prenatal Counseling on the Maternal Health Benefits of Lactation: A Randomized Trial.

Objective: To assess the effects of prenatal counseling about the maternal health benefits of lactation on postpartum knowledge, breastfeeding intentions, and infant feeding behaviors. Materials and Methods: We conducted a randomized trial with 411 nulliparous U.S.-born women carrying a singleton gestation. Participants were recruited online; after completing a baseline survey that assessed breastfeeding knowledge and intentions, participants were randomized to receive a 10-minute virtual counseling session about the benefits of breastfeeding or attention-control counseling about smoke-free homes. We collected data on breastfeeding knowledge, intentions, and infant feeding behaviors through 12 months postpartum and conducted an intention-to-treat analysis. Results: On enrollment, awareness of the maternal health benefits of lactation was similarly low in both study groups. Postpartum, participants who received this prenatal counseling intervention had significantly greater awareness that breastfeeding decreases maternal risk of breast cancer, ovarian cancer, diabetes, heart disease, and rheumatoid arthritis (p < 0.001 for all). On enrollment, intended duration of breastfeeding was similar between groups (10.1 months versus 9.7 months, p = 0.41). At 1-month postpartum, intended duration of breastfeeding had increased from baseline among those who received this counseling (+0.7 months versus -0.7 months among controls, p = 0.004); among intervention participants intended duration of breastfeeding decreased less at 3 (-0.8 versus -1.6, p = 0.18), 6 (-2.0 versus -3.0, p = 0.06), 9 (-2.8 versus -4.2, p = 0.03), and 12 months postpartum (-4.8 versus -6.2, p = 0.09). Rates of exclusive breastfeeding and any breastfeeding were similar between groups. Conclusion: Prenatal counseling on the maternal health benefits of lactation increases awareness of these maternal health benefits and extends intended duration of breastfeeding. ClinicalTrials.gov Identifier: NCT04601987.

Understanding of Lactational Amenorrhea As a Contraceptive Method Among U.S. Pregnant Women.

Introduction: The lactational amenorrhea method (LAM) of postpartum contraception is more effective than typical use of condoms or birth control pills. However, LAM may be underutilized due to incomplete perinatal counseling. Methods: We compared perceptions of the effectiveness of postpartum contraceptives including LAM among U.S.-born nulliparous pregnant women recruited using social media for a trial (NCT04601987). We used descriptive statistics to summarize data. Results: Of 760 individuals screened, 627 were invited to participate, and 451 (72%) were enrolled. Most (81%) had a college degree; 79% intended to breastfeed for at least 1 month. Only 8% believed exclusive breastfeeding reduces the chance of pregnancy "a lot" within 6 months of delivery and 2% indicated that exclusive breastfeeding is typically more effective than birth control pills or condoms. Compared with those planning to use other postpartum contraceptives, the 17% of respondents who planned to use LAM were more likely to know that breastfeeding delays return of menses (84% versus 44%, p ≤ 0.0001) and provides protection from pregnancy until menses return (54% versus 22%, p ≤ 0.0001). Although 25% of those planning to use LAM believed exclusive breastfeeding reduces pregnancy risk by "a lot," only 5% thought LAM is more effective than birth control pills and only 9% thought that it is more effective than condoms. Conclusions/Implications: First-time U.S. mothers are often unaware of breastfeeding's effects on menses and fertility. Clinicians providing counseling about postpartum contraceptive options should include more information on LAM.

Combined Oral Contraceptive Adherence and Pregnancy Rates.

OBJECTIVE: To assess the relationship of adherence and pregnancy in participants using an estetrol and drospirenone combined oral contraceptive. METHODS: We 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. RESULTS: Among 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 <.001). No pregnancies occurred in 2,216 cycles when one or more pills were missed and missed-pill instructions were followed. All pregnancies related to not taking pills occurred in the first three cycles. Pregnancy rates ranged from 0% to 0.21% per cycle with no significant trend by cycle ( P =.45). CONCLUSION: Pregnancy occurs more frequently when combined oral contraceptive users report not taking all hormone-containing pills per 28-day cycle and exceeds 1% only when more than two pills are not taken. Pregnancies in participants who reported missed pills occurred only when missed-pill instructions were not followed. A 0.09% pregnancy risk per cycle among users of a 24 hormone and four placebo pills formulation who report taking all pills likely approximates a true method-failure rate. FUNDING SOURCE: Estetra SRL, an affiliate company of Mithra Pharmaceuticals. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02817828 and NCT02817841.

Texas Senate Bill 8 and Abortion Experiences in Patients With Fetal Diagnoses: A Qualitative Analysis.

OBJECTIVE: To 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). METHODS: In 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. RESULTS: We 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?"). CONCLUSION: Abortion 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.

Vaccination and treatment options for SARS-CoV2 infection affecting lactation and breastfeeding.

The COVID-19 pandemic has posed considerable challenges to the health of lactating individuals. Vaccination remains one of the most important strategies for prevention of moderate to severe COVID-19 infection and is associated with protective benefits for lactating individuals and their breastfed infants with overall mild side effects. The current recommendations for COVID-19 treatment in lactating individuals includes remdesivir and dexamethasone for hospitalized patients and Paxlovid® (nirmatrelavir + ritonavir) as outpatient treatment in those with mild disease. As the pandemic continues to evolve with new COVID-19 variants, alternative therapeutic options are potentially needed, and it is critical to include lactating individuals in research to evaluate the safety and efficacy of COVID-19 treatment options in this population.

The effect of deliberate non-adherence to a norgestrel progestin-only pill: A randomized, crossover study.

OBJECTIVES: To 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 DESIGN: In a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.0 kg/m² and regular ovulatory cycles completed a baseline 28-day cycle with correct daily pill use followed by two intervention cycles in which, around mid-cycle, one pill was taken 6 hours late or missed completely. We undertook ovarian ultrasonography, estradiol and progesterone measurement, and cervical mucus assessments every 3 to 4 days (daily around the time of the incorrect use) and based the theoretical contraceptive protection score on ovarian activity status, cervical mucus and their temporal relationship. RESULTS: Of 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility. CONCLUSIONS: Delayed or missed intake of a single norgestrel 0.075 mg progestogen-only pill appears to have little effect on theoretical contraceptive efficacy. IMPLICATIONS: This biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.

Racial Inequities in Breastfeeding Counseling Among Pregnant People Who Use Cannabis.

We examined how breastfeeding advice in the context of cannabis use differed by race and ethnicity. Data from the 2017-2018 PRAMS (Pregnancy Risk Assessment Monitoring System) survey were used to assess differences in breastfeeding guidance related to cannabis use among 1,213 individuals who self-reported cannabis use 3 months before or during pregnancy. A multivariable logistic regression model was specified to examine the extent to which the odds of receiving prenatal advice against breastfeeding if using cannabis differed by self-reported race and ethnicity. We found that non-Hispanic Black people were four times more likely than non-Hispanic White people to be advised against breastfeeding if using cannabis (adjusted odds ratio 4.1, 95% CI 2.1-8.2). Pregnant non-Hispanic Black people were disproportionately advised not to breastfeed if using cannabis.

Tolerability and safety of the estetrol/drospirenone combined oral contraceptive: Pooled analysis of two multicenter, open-label phase 3 trials.

OBJECTIVES: To evaluate tolerability and safety of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg oral contraceptive using pooled data from two, multicenter, phase 3 trials. STUDY DESIGN: The two trials enrolled participants aged 16-50 years with a body mass index ≤35.0 kg/m2 to use E4/DRSP in a 24/4-day regimen for up to 13 cycles. We pooled data from participants who used at least one E4/DRSP dose and had a follow-up assessment to analyze adverse events (AEs), vital signs, and laboratory parameters, including serum lipids, glucose, glycated hemoglobin, and potassium. We consolidated similar Medical Dictionary for Regulatory Activities preferred terms into groupings. RESULTS: Of 3725 participants enrolled, we included 3417 in the analyses of whom 1786 (52.3%) reported ≥1 AE. Most participants with reported AEs had AEs that investigators rated as mild or moderate (n = 1665, 93.2%); of participants reporting AEs, 1105 (61.9%) did so during cycles 1 to 3. In total, 981 (28.7%) participants experienced ≥1 treatment-related AE, most frequently related to bleeding complaints (n = 323, 9.5%), breast pain or tenderness (n = 136, 4.0%), acne (n = 113, 3.3%), and mood disturbance (n = 111, 3.2%). Discontinuation due to treatment-related AEs occurred in 272 participants (8.0%), with only bleeding complaints (n = 97, 2.8%) and mood disturbance (n = 38, 1.1%) at rates exceeding 1%. Three participants experienced serious AEs, which the site investigators considered treatment-related: one venous thromboembolism, one worsening of depression, and one ectopic pregnancy. We found no clinically relevant changes in weight, blood pressure, heart rate, or laboratory parameters during treatment. CONCLUSIONS: E4/DRSP is associated with a favorable tolerability and safety profile. IMPLICATIONS STATEMENT: Pooling data allowed for a robust assessment of tolerability and safety, including relatively infrequent events. Other than bleeding complaints and mood disturbance, no adverse event resulted in E4/DRSP discontinuation at rates >1%. Post-marketing surveillance studies are needed to evaluate long-term safety of the E4/DRSP COC and population-based venous thromboembolism risks.

Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials.

OBJECTIVE: To evaluate overall and subgroup efficacy of an estetrol (E4) 15 mg drospirenone (DRSP) 3 mg oral contraceptive in a 24/4-day regimen. STUDY DESIGN: We pooled efficacy outcomes from 2 pivotal phase 3 contraceptive trials with E4/DRSP conducted in the United States/Canada and Europe/Russia. We assessed Pearl Index (PI; pregnancies per 100 participant-years) and 13-cycle life-table pregnancy rates in at-risk cycles (confirmed intercourse and no other contraceptive use) among participants 16 to 35 years. We calculated PI by age and further subcategorization (contraceptive history and body mass index [BMI]). We performed multivariable analysis using Cox regression to assess impact of potential confounding factors. RESULTS: Analyses included 3027 participants, of whom 451 (14.9%) had a BMI ≥30 kg/m2. The pooled PI was 1.52 (95% confidence interval 1.04-2.16) and the 13-cycle life-table pregnancy rate was 1.28% (0.83%-1.73%). We calculated unadjusted pooled PI in participants 16 to 25 years and 26 to 35 years of 1.61 (0.94-2.57) and 1.43 (0.78-2.40), respectively; in new starters and switchers of 1.88 (1.09-3.00) and 1.24 (0.68-2.08), respectively; and by BMI <25 kg/m2, 25 to 29.9 kg/m2, and ≥30 kg/m2 of 1.14 (0.64-1.88), 2.19 (1.05-4.03), and 2.27 (0.83-4.94), respectively. In multivariable analysis, we found associations of prior pregnancy (hazard ratio [HR] 3.61[1.56-8.38]), Black race (HR 4.61[1.97-10.80]), age 16 to 25 years (HR 2.37[1.09-5.15]) and compliance <99% of expected pills (HR 4.21[2.04-8.66]) with conception. CONCLUSION: E4/DRSP is an effective oral contraceptive overall and across subgroups stratified by age, contraceptive history, and BMI. Other than compliance, predictors of contraceptive failure are nonmodifiable. IMPLICATIONS STATEMENT: Pooled results from two phase 3 trials demonstrate high contraceptive efficacy of the novel estetrol-drospirenone oral contraceptive. Several non-modifiable risk factors, including prior pregnancy, race, and age, are associated with higher pregnancy risk. Additional research is needed to better understand predictors of combined oral contraceptive failure.

Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women.

OBJECTIVE: To 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 DESIGN: We 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. RESULTS: We 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. CONCLUSION: E4/DRSP use results in a predictable bleeding pattern with limited unscheduled bleeding/spotting. Noncompliance and BMI affect bleeding patterns. IMPLICATIONS STATEMENT: Most 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.

New Contraception Update - Annovera, Phexxi, Slynd, and Twirla.

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 < 30 kg/m2 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.

Implementation of telemedicine preoperative visits for abortion procedures through 18 weeks gestation at a Northern California hospital-based center.

OBJECTIVE: Describe the implementation of a preoperative telemedicine program at a Northern California hospital-based center for abortion procedures requiring cervical preparation. STUDY DESIGN: We 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. RESULTS: Implementation 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. CONCLUSION: A 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. IMPLICATIONS: Telemedicine 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.

Future Pregnancy Considerations after Premature Birth of an Infant Requiring Intensive Care: A Qualitative Study.

BACKGROUND: Postpartum 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. METHODS: We 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. RESULTS: We 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 6/7 weeks 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. CONCLUSIONS: Preterm 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.

Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception.

OBJECTIVE: To evaluate the cervical mucus effects of a norgestrel 0.075 mg progestin-only contraceptive pill over a 28-day cycle. STUDY DESIGN: We 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. RESULTS: Excluding 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). CONCLUSIONS: Norgestrel 0.075 mg daily prevents mucus changes that favor fertility, even during ovulatory cycles. IMPLICATIONS: Daily 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.

Complex family planning and pediatric hematology oncology integrated clinic for young people with blood disorders and heavy or abnormal menstrual bleeding.

OBJECTIVES: To 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. RESULTS: We 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. CONCLUSION: Most 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. IMPLICATIONS: Patients 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.

Mifepristone prior to osmotic dilators for dilation and evacuation cervical preparation: A randomized, double-blind, placebo-controlled pilot study.

OBJECTIVES: To 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 DESIGN: We 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). RESULTS: Of 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. CONCLUSION: Our 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. IMPLICATIONS: Mifepristone 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.

Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results.

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.