Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study.

OBJECTIVE: To compare real-world effectiveness of hysteroscopic to laparoscopic sterilization. DESIGN: Retrospective cohort of Medicaid claims for hysteroscopic or laparoscopic sterilization procedures performed in California, 2008-2014. After excluding postpartum procedures, we applied log-linear (Poisson) event-history regression models for clustered person-period data, weighted for propensity to receive either sterilization procedures, and adjusted for sociodemographic and clinical variables to examine the poststerilization pregnancy rates. SETTING: Clinics, hospitals. PATIENT(S): Women aged 18-50 years with Medicaid claims between January 1, 2008, and August 31, 2014. INTERVENTION(S): Hysteroscopic or laparoscopic sterilization procedure. MAIN OUTCOME MEASURE(S): Poststerilization pregnancy measured by pregnancy-related claims. RESULT(S): Among women with hysteroscopic (n = 5,906) or laparoscopic (n = 23,965) sterilization, poststerilization pregnancy claims were identified for 4.74% of women after hysteroscopic sterilization and 5.57% after laparoscopic sterilization. The pregnancy rates decreased over time after either procedure. Twelve months after the procedure, the crude incidence of pregnancy claims was higher for hysteroscopic sterilization than for laparoscopic sterilization (3.26 vs. 2.61 per 100 woman-years), but the propensity-weighted adjusted incidence rate ratio was 1.06 (95% confidence interval [CI], 0.85-1.26). Between 13 and 24 months after the procedure, there were fewer pregnancies for women after hysteroscopic sterilizations than for those after laparoscopic sterilizations (adjusted incidence rate ratio, 0.63 [95% CI, 0.45-0.88]), with no statistically significant differences in later years. The cumulative pregnancy rates 5 years after sterilization were lower with hysteroscopic sterilization than with laparoscopic sterilization (6.26 vs. 7.22 per 100 woman-years; propensity-weighted, adjusted risk ratio, 0.76 [95% CI, 0.62-0.90]). The poststerilization pregnancy rates varied by age and race/ethnicity. CONCLUSION(S): The pregnancy rates after female sterilization are higher than expected, whether performed hysteroscopically or laparoscopically. These findings are reassuring that the effectiveness of hysteroscopic sterilization was not inferior to laparoscopic sterilization. CLINICAL TRIAL REGISTRATION NUMBER: NCT03438682.

Patient-Centered Safety Outcomes After Hysteroscopic Compared With Laparoscopic Sterilization.

OBJECTIVE: To evaluate the real-world safety of hysteroscopic compared with laparoscopic surgical sterilization. METHODS: We conducted a retrospective cohort study of Medicaid claims for hysteroscopic or laparoscopic sterilization procedures performed in California, 2008-2014, among women aged 18-50 years. After excluding postpartum procedures, we applied log-linear (Poisson) event-history regression models for clustered person-period data, weighted for propensity to receive either sterilization procedures, and adjusted for sociodemographic and clinical characteristics that may affect outcomes of interest to patients and physicians. We assessed the following outcomes: procedural complications, additional surgical procedures (eg, hysterectomy), repeat sterilization procedures, pelvic pain, pelvic inflammatory disease (PID), abdominal pain, nonabdominal pain, and abnormal uterine bleeding. RESULTS: We identified 5,906 women who had undergone hysteroscopic and 23,965 who had undergone laparoscopic sterilization. After adjusting for sociodemographic and health history, women who had hysteroscopic sterilization were less likely to have claims for procedural complications (eg, transfusion, P<.001) on the day of surgical sterilization and additional surgical procedures (eg, hysterectomy, P=.002 at day 2-3 months postprocedure) than laparoscopic sterilization. Claims for a repeat attempt at sterilization were more common after hysteroscopic sterilization within 1 year (adjusted incident rate ratio 3.48, 95% CI 2.69-4.27) and within 5 years (adjusted incident rate ratio 2.32, 95% CI 1.84-2.79) than laparoscopic sterilization. Claims for pelvic pain (adjusted incident rate ratio 0.77, 95% CI 0.65-0.92 at 2 years), abdominal pain (adjusted incident rate ratio 0.80, 95% CI 0.68-0.93 at 7-12 months), and PID (adjusted incident rate ratio 0.55, 95% CI 0.33-0.93 at 2 years) were less common after hysteroscopic than laparoscopic sterilization. Although abnormal uterine bleeding claims were more common after hysteroscopic than laparoscopic sterilization up to 12 months postprocedure (adjusted incident rate ratio 1.37, 95% CI 1.06-1.77 at 7-12 months), there were no significant differences between methods 1 year after the procedure. CONCLUSION: Compared with laparoscopic sterilization, hysteroscopic sterilization was followed by more claims for repeat sterilization procedures and abnormal uterine bleeding, but fewer procedural complications and fewer claims for pelvic or abdominal pain. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03438682.

Surveillance for gestational trophoblastic neoplasia following molar pregnancy: a cost-effectiveness analysis.

BACKGROUND: Historically, published guidelines for care after molar pregnancy recommended monitoring human chorionic gonadotropin levels for the development of gestational trophoblastic neoplasia until normal and then for 6 months after the first normal human chorionic gonadotropin. However, there are little data underlying such recommendations, and recent evidence has demonstrated that gestational trophoblastic neoplasia diagnosis after human chorionic gonadotropin normalization is rare. OBJECTIVE: We sought to estimate the cost-effectiveness of alternative strategies for surveillance for gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after complete and partial molar pregnancy. STUDY DESIGN: A Markov-based cost-effectiveness model, using monthly cycles and terminating after 36 months/cycles, was constructed to compare alternative strategies for asymptomatic human chorionic gonadotropin surveillance after the first normal (none; monthly testing for 1, 3, 6, and 12 months; or every 3-month testing for 3, 6, and 12 months) for both complete and partial molar pregnancy. The risk of reduced surveillance was modeled by increasing the probability of high-risk disease at diagnosis. Probabilities, costs, and utilities were estimated from peer-reviewed literature, with all cost data applicable to the United States and adjusted to 2020 US dollars. The primary outcome was cost per quality-adjusted life year ($/quality-adjusted life year) with a $100,000/quality-adjusted life year willingness-to-pay threshold. RESULTS: Under base-case assumptions, we found no further surveillance after the first normal human chorionic gonadotropin to be the dominant strategy from both the healthcare system and societal perspectives, for both complete and partial molar pregnancy. After complete mole, this strategy had the lowest average cost (healthcare system, $144 vs maximum $283; societal, $152 vs maximum $443) and highest effectiveness (2.711 vs minimum 2.682 quality-adjusted life years). This strategy led to a slightly higher rate of death from gestational trophoblastic neoplasia (0.013% vs minimum 0.009%), although with high costs per gestational trophoblastic neoplasia death avoided (range, $214,000 to >$4 million). Societal perspective costs of lost wages had a greater impact on frequent surveillance costs than rare gestational trophoblastic neoplasia treatment costs, and no further surveillance was more favorable from this perspective in otherwise identical analyses. No further surveillance remained dominant or preferred with incremental cost-effectiveness ratio of <$100,000 in all analyses for partial mole, and most sensitivity analyses for complete mole. Under the assumption of no disutility from surveillance, surveillance strategies were more effective (by quality-adjusted life year) than no further surveillance, and a single human chorionic gonadotropin test at 3 months was found to be cost-effective after complete mole with incremental cost-effectiveness ratio of $53,261 from the healthcare perspective, but not from the societal perspective (incremental cost-effectiveness ratio, $288,783). CONCLUSION: Largely owing to the rare incidence of gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after molar pregnancy, prolonged surveillance is not cost-effective under most assumptions. It would be reasonable to reduce, and potentially eliminate, current recommendations for surveillance after human chorionic gonadotropin normalization after molar pregnancy, particularly among partial moles. With any reduction in surveillance, patients should be counseled on symptoms of gestational trophoblastic neoplasia and established in routine gynecologic care.

Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial.

BACKGROUND: Early pregnancy loss is a common event in the first trimester, occurring in 15%-20% of confirmed pregnancies. A common evidence-based medical regimen for early pregnancy loss uses misoprostol, a prostaglandin E1 analog, with a dosage of 800 µg, self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in patients with a closed cervical os, with 29% of patients experiencing early pregnancy loss requiring a second dose after 3 days and 16% of patients eventually requiring a uterine aspiration procedure. OBJECTIVE: This study aimed to evaluate clinical predictors associated with treatment success in patients receiving medical management with mifepristone-misoprostol or misoprostol alone for early pregnancy loss. STUDY DESIGN: We performed a planned secondary analysis of a randomized trial comparing mifepristone-misoprostol with misoprostol alone for management of early pregnancy loss. The published prediction model for treatment success of single-dose misoprostol administered vaginally included the following variables: active bleeding, type of early pregnancy loss (anembryonic pregnancy or embryonic and/or fetal demise), parity, gestational age, and treatment site; previous significant predictors were vaginal bleeding within the past 24 hours and parity of 0 or 1 vs >1. To determine if these characteristics predicted differential proportions of patients with treatment success or failure, we performed bivariate analyses; given the small proportion of treatment failures in the combined treatment arm, both arms were combined for analysis. Thereafter, we performed a logistic regression analysis to assess the effect of these predictors collectively in each of the 2 treatment groups separately as well as in the full cohort as a proxy for the combined treatment arm. Finally, by using receiver operating characteristic curves, we tested the ability of these predictors in association with misoprostol treatment success to discriminate between treatment success and treatment failure. To quantify the ability of the score to discriminate between treatment success and treatment failure in each treatment arm as well as in the entire cohort, we calculated the area under the curve. Using multivariable logistic regression, we then assessed our study population for other predictors of treatment success in both treatment groups, with and without mifepristone pretreatment. RESULTS: Overall, 297 evaluable participants were included in the primary study, with 148 in the mifepristone-misoprostol combined treatment group and 149 in the misoprostol-alone treatment group. Among patients who had vaginal bleeding at the time of treatment, 15 of 17 (88%) in the mifepristone-misoprostol combined treatment group and 12 of 17 (71%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. Among patients with a parity of 0 or 1, 94 of 108 (87%) in the mifepristone-misoprostol treatment group and 66 of 95 (69%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. These clinical characteristics did not predict treatment success in the combined cohort alone (area under the curve=0.56; 95% confidence interval, 0.48-0.64). No other baseline clinical factors predicted treatment success in the misoprostol-alone treatment arm or mifepristone pretreatment arm. In the full cohort, the significant predictors of treatment success were pretreatment with mifepristone (adjusted odds ratio=2.51; 95% confidence interval, 1.43-4.43) and smoking (adjusted odds ratio=2.15; 95% confidence interval, 1.03-4.49). CONCLUSION: No baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors.

Telehealth Interventions to Improve Obstetric and Gynecologic Health Outcomes: A Systematic Review.

OBJECTIVE: To systematically review the effectiveness of telehealth interventions for improving obstetric and gynecologic health outcomes. DATA SOURCES: We conducted a comprehensive search for primary literature in ClinicalTrials.gov, Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, and MEDLINE. METHODS OF STUDY SELECTION: Qualifying primary studies had a comparison group, were conducted in countries ranked very high on the United Nations Human Development Index, published in English, and evaluated obstetric and gynecologic health outcomes. Cochrane Collaboration's tool and ROBINS-I tool were used for assessing risk of bias. Summary of evidence tables were created using the United States Preventive Services Task Force Summary of Evidence Table for Evidence Reviews. TABULATION, INTEGRATION, RESULTS: Of the 3,926 published abstracts identified, 47 met criteria for inclusion and included 31,967 participants. Telehealth interventions overall improved obstetric outcomes related to smoking cessation and breastfeeding. Telehealth interventions decreased the need for high-risk obstetric monitoring office visits while maintaining maternal and fetal outcomes. One study found reductions in diagnosed preeclampsia among women with gestational hypertension. Telehealth interventions were effective for continuation of oral and injectable contraception; one text-based study found increased oral contraception rates at 6 months. Telehealth provision of medication abortion services had similar clinical outcomes compared with in-person care and improved access to early abortion. Few studies suggested utility for telehealth to improve notification of sexually transmitted infection test results and app-based intervention to improve urinary incontinence symptoms. CONCLUSION: Telehealth interventions were associated with improvements in obstetric outcomes, perinatal smoking cessation, breastfeeding, early access to medical abortion services, and schedule optimization for high-risk obstetrics. Further well-designed studies are needed to examine these interventions and others to generate evidence that can inform decisions about implementation of newer telehealth technologies into obstetrics and gynecology practice.

Gestational Trophoblastic Neoplasia After Human Chorionic Gonadotropin Normalization Following Molar Pregnancy: A Systematic Review and Meta-analysis.

OBJECTIVE: To estimate the incidence of gestational trophoblastic neoplasia following complete and partial molar pregnancy after reaching normal human chorionic gonadotropin (hCG) levels to guide evidence-based follow-up recommendations. DATA SOURCES: MEDLINE, EMBASE, Web of Science, POPLINE, Cochrane, and ClinicalTrials.gov were searched from inception to November 2018, using the intersection of "gestational trophoblastic disease," "molar pregnancy," and "human chorionic gonadotropin" themes. METHODS OF STUDY SELECTION: Search results were screened to identify cohort studies of molar pregnancy reporting gestational trophoblastic neoplasia development, with at least 6 months of intended normal hCG follow-up. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently identified articles for inclusion. Data were extracted using a standardized form. For meta-analysis, cumulative incidence of gestational trophoblastic neoplasia, with CIs by the Agresti-Coull method, and pooled risk ratios (RRs) comparing complete and partial mole were calculated. Among the 19 eligible studies that reported adequate data for inclusion in the primary meta-analysis, we found low incidence of gestational trophoblastic neoplasia after normal hCG level following both complete mole (64/18,357, 0.35%, 95% CI 0.27-0.45%), and partial mole (5/14,864, 0.03%, 95% CI 0.01-0.08%). There was a significantly higher risk of gestational trophoblastic neoplasia after complete compared with partial molar pregnancy (RR 4.72, 95% CI 1.81-12.3, P=.002). Among gestational trophoblastic neoplasia cases after normal hCG level following complete mole, 89.6% occurred when the time from evacuation to normalization was 56 days or longer, and 60.7% were diagnosed beyond the commonly recommended 6-month surveillance interval. Sensitivity analyses, including those limiting to studies at low risk of bias, did not significantly affect results. We found an overall incidence of gestational trophoblastic neoplasia of 15.7% for complete mole (1,354/8,611, 95% CI 15.0-16.5%) and 3.95% for partial mole (221/5,593, 95% CI 3.47-4.50%). CONCLUSION: Gestational trophoblastic neoplasia development after normal hCG level following molar pregnancy is rare. Recommendations for frequency and duration of hCG follow-up can be minimized to lessen burden on patients and informed by the type of molar pregnancy and time interval from uterine evacuation to hCG normalization. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42019116414.

Gynecologic Care for Women With Physical Disabilities: A Qualitative Study of Patients and Providers.

BACKGROUND: Women with physical disabilities have unmet gynecologic care needs, including disparities in cancer screening and contraceptive care, when compared with women without physical disabilities. Our objective was to qualitatively assess provider and patient perspectives regarding barriers to gynecologic health care for women with physical disabilities. METHODS: We used purposive sampling to recruit women with physical disabilities and gynecology providers who had experience caring for this population at two university hospitals. Patient and provider participants completed in-depth, semistructured interviews investigating their experiences with and barriers to receiving or providing gynecologic care. Transcripts were systematically analyzed by reviewing assigned codes and performing thematic analysis. We planned a sample size of at least 20 patient and provider participants to allow for saturation of thematic content. RESULTS: We interviewed 29 women with physical disabilities and 20 providers. Important themes for providers and patients centered around adequate time spent during appointments, challenges with the gynecologic examination, inadequate facilities, clinical space limitations, and lack of formal provider and staff training in caring for this population. CONCLUSIONS: Providers were motivated to provide quality care for women with disabilities, but encountered systems and training barriers. Patients and providers had concordant impressions of barriers that influenced equitable and patient-centered care, with structural barriers, including a lack of accessible space, closely related to perceptions of health care inequity between women with and without physical disabilities.

Relationship between body mass index and operative time in women receiving immediate postpartum tubal ligation.

OBJECTIVES: The aim of the study was to (1) assess the relationship between body mass index (BMI) and operative time during immediate postpartum tubal ligation procedures and to (2) determine whether operative time is non-inferior in women with BMI ≥30 versus women with BMI <30 and in women with BMI ≥40 versus women with BMI <40. STUDY DESIGN: We conducted a retrospective cohort study of women who received immediate postpartum tubal ligations following vaginal delivery from 2013 to 2017 at a university hospital. We abstracted demographic information, patient and procedural characteristics, and clinical outcomes. We assessed the relationship between BMI and operative time via linear regression. We also conducted non-inferiority analysis to determine whether the mean operative time in women with BMI ≥30 was non-inferior to the mean operative time in women with BMI <30, within a non-inferiority margin of 10 min. We compared intraoperative and postoperative complications in the two groups. RESULTS: A total of 279 women were included for analysis, among whom N=79 (28%) had a BMI of 25-29.9 and N=171 (61%) had a BMI ≥30. Demographic characteristics were similar in both groups. We found that operative time increased by 35 s for each one-point increase in BMI (p<.01). Although mean operative time was 46.1 min (n=171; 95% CI 43.7, 48.6 min) for women with BMI ≥30 and 40.6 min (n=108; 95% CI 37.9 min, 43.4 min) for women with BMI <30, (p<.01), it was non-inferior within a 10-min margin. There was no difference in rates of intraoperative or postoperative complications, incision length, total anesthesia time, and median length of stay between women with BMI ≥30 and BMI <30. CONCLUSION: There is a small increase in postpartum tubal ligation operative time with increasing BMI. However, among women who received immediate postpartum tubal ligations at our institution, women with BMI ≥30 versus BMI <30 had operative times that were non-inferior within a 10-min margin. IMPLICATIONS: While increasing body mass index slightly increases the operative time for immediate postpartum tubal ligations, this increase in time does not appear to be clinically significant.

Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months. METHODS: In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months. RESULTS: From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment. CONCLUSION: Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.

Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of insertion of etonogestrel implants with mifepristone compared with after the abortion on the risks of medical abortion failure and repeat pregnancy over the subsequent 6 months. METHODS: In a randomized trial, we assigned patients undergoing medical abortion to receive etonogestrel implants either with the mifepristone (Quickstart group) or after the abortion (Afterstart group). We followed them for 7 months to ascertain abortion outcome, pregnancies, and contraception use. RESULTS: Between September 2013 and August 2014, we enrolled 236 participants in the Quickstart group and 240 in the Afterstart group. To examine abortion failure, we conducted a noninferiority analysis from which we excluded nine participants who had missing outcome data and four with specified protocol violations. Of the rest, 9 of 229 (3.9%) and 9 of 234 (3.8%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the difference of 0.08% (90% confidence interval -3.1% to 3.3%) excluded our prestipulated noninferiority margin of 5 percentage points. Among participants with pregnancy follow-up through 6 months, 1 of 213 (0.5%) and 3 of 208 (1.4%) in the Quickstart and Afterstart groups, respectively, became pregnant within that time; 6-month pregnancy rates did not differ significantly by group (exact log-rank test, P=.28). At enrollment, significantly more participants in the Quickstart group than in the Afterstart group were satisfied with their group assignments (187/236 [79%] compared with 129/240 [54%], respectively; P<.001). CONCLUSION: Insertion of etonogestrel implants with mifepristone did not appreciably increase medical abortion failure risk and it enhanced patient satisfaction, but we found no evidence that it decreased repeat pregnancy rates. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01902485.

Inflammation or infection at the time of second trimester induced abortion.

BACKGROUND: Induced abortion via dilation and evacuation (D&E) typically involves cervical preparation. Some clinicians also induce fetal death in the second trimester. We designed this study to determine if the combination of intra-amniotic digoxin and osmotic dilators induced intrauterine inflammatory changes. STUDY DESIGN: Twenty-two women requesting abortion at 19-23 weeks gestation had amniotic fluid sent for measurement of interleukin-6 (IL-6), interleukin-8 (IL-8), tumor necrosis factor-α (TNF-α), white blood cell (WBC) count and anaerobic and aerobic cultures on day 1, before dilators and digoxin amnioinjection. Sampling was repeated on Day 2, prior to D&E. RESULTS: All subjects had significantly elevated IL-6, IL-8 and TNF-α in the amniotic fluid on Day 2. The median difference for IL-6 was 19,893.4 pg/mL (p<.0001), 7040.7 pg/mL (p<.0001) for IL-8 and 181.0 pg/mL (p<.0001) for TNF-α. There was no significant difference in WBC count. There were no clinically significant positive cultures and no clinical infections. CONCLUSION: The administration of intra-amniotic digoxin and the placement of osmotic dilators prior to D&E create an intrauterine inflammatory response.