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.

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.

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.

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.

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.

Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.

OBJECTIVE: To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism. STUDY DESIGN: We 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 ≥40 pg/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. RESULTS: Sixty-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 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/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. CONCLUSIONS: Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use. IMPLICATIONS: A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.

Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.

OBJECTIVE: To estimate the efficacy and safety of mifepristone antagonization with high-dose oral progesterone. METHODS: We 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. RESULTS: We 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. CONCLUSION: We 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 REGISTRATION: ClinicalTrials.gov, NCT03774745.

Persistent free-floating pelvic trophoblastic cysts following an interstitial ectopic pregnancy.

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.

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

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

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

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

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

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