Relationship between plasma concentration of 17-hydroxyprogesterone caproate and gestational age at preterm delivery.

BACKGROUND: The effectiveness of 17-hydroxyprogesterone caproate is unclear as trials have provided conflicting results. With the absence of fundamental pharmacologic studies addressing dosing or the relationship between drug concentration and gestational age at delivery, the effectiveness of the medication cannot be evaluated. OBJECTIVE: This study aimed to evaluate the relationship between plasma concentrations of 17-hydroxyprogesterone caproate and preterm birth rates and gestational age at preterm delivery and to assess the safety of the 500-mg dose. STUDY DESIGN: This study recruited 2 cohorts with previous spontaneous preterm birth; 1 cohort (n=143) was randomly assigned to either 250-mg or 500-mg 17-hydroxyprogesterone caproate, and the other cohort (n=16) was receiving the 250-mg dose for routine care. Steady-state trough plasma concentrations of 17-hydroxyprogesterone caproate obtained at 26 to 30 weeks of gestation were correlated to dose, spontaneous preterm birth rates, and measures of gestational length. Furthermore, maternal and neonatal safety outcomes were evaluated according to dose. RESULTS: There was a dose proportional increase in trough plasma concentrations with the 250-mg (median, 8.6 ng/m; n=66) and 500-mg (median, 16.2 ng/mL; n=55) doses. In 116 compliant participants with blood samples, drug concentration was not related to the spontaneous preterm birth rate (odds ratio, 1.00; 95% confidence interval, 0.93-1.08). However, there was a significant relationship between drug concentration and both the interval from the first administration to delivery (interval A: coefficient, 1.11; 95% confidence interval, 0.00-2.23; P=.05) and the interval from the 26- to 30-week blood draw to delivery (interval B: coefficient, 1.56; 95% confidence interval, 0.25-2.87; P=.02). The spontaneous preterm birth rate or measures of gestational length were not related to dose. Postenrollment cerclage adversely affected all pharmacodynamic assessments because it was a powerful predictor of spontaneous preterm birth (odds ratio, 4.03; 95% confidence interval, 1.24-13.19; P=.021) and both measures of gestational length (interval A [coefficient, -14.9; 95% confidence interval, -26.3 to -3.4; P=.011] and interval B [coefficient, -15.9; 95% confidence interval, -25.8 to -5.9; P=.002]). Initial cervical length was significantly related to the risk of postenrollment cerclage (odds ratio, 0.80; 95% confidence interval, 0.70-0.92; P=.001). Maternal and neonatal safety outcomes were similar in both dosing groups. CONCLUSION: In this pharmacodynamic study, trough plasma 17-hydroxyprogesterone caproate concentrations were significantly associated with gestational age at preterm birth but not with the preterm birth rate. Postenrollment cerclage was a powerful predictor of spontaneous preterm birth rate and gestational length. Initial cervical length predicted the risk of postenrollment cerclage. Adverse events were similar with the 500-mg and 250-mg doses of 17-hydroxyprogesterone caproate.

Labour induction for termination of pregnancy with severe fetal anomalies after 24 weeks' gestation: a case series and systematic review of the literature.

PURPOSE: Under some circumstances, individuals choose to undergo pregnancy termination for foetal anomalies in the second half of pregnancy. This report provides objective information on the clinical management of such cases and a systematic review of the literature on labour induction outcomes for third-trimester abortion using mifepristone-misoprostol. MATERIALS AND METHODS: The study is a case series describing outcomes for labour induction abortion for foetal anomalies, at gestational age 24 weeks and beyond. A systematic review was performed, searching PubMed, Embase, and Cochrane databases. Two independent authors reviewed and quality assessed the data from the articles. RESULTS: During a two-year period, 15 patients met inclusion criteria. Fourteen patients received mifepristone and misoprostol, and one received oxytocin. All delivered vaginally. Thirteen patients delivered within 24 hours of the first misoprostol dose, and half delivered within 12 hours. The average interval from misoprostol initiation to foetal expulsion was 15.5 hours in our series. The systematic review identified nine articles for inclusion, all retrospective studies. Labour induction protocols for mifepristone-misoprostol, reporting of gestational age, and key comparisons varied greatly. CONCLUSIONS: The case series illustrates successful termination of pregnancy primarily using combined mifepristone-misoprostol. Certainty of current evidence is low, based on the GRADE framework. Future research is necessary on third-trimester outcomes with mifepristone-misoprostol.

Vasectomy interest and awareness among patients and their partners in prenatal clinics in the United States.

OBJECTIVE: Although vasectomy is safer, more effective and less expensive than tubal ligation, rates of permanent contraception are consistently higher in women than in men. We sought to explore vasectomy interest and awareness in patients and their partners during prenatal visits, a time when contraceptive counselling is typically performed. METHODS: Anonymous surveys were distributed between January and July 2019 to a cross-sectional, convenience sample of pregnant women and their partners, if available, presenting for outpatient prenatal care at two hospitals (one public, one private) serving different patient populations in Chicago, Illinois, USA. Survey questions gauged participant awareness and interest in vasectomies. RESULTS: Surveys were completed by 436 individuals (78% female, 24% male). Seventy percent of respondents indicated interest in vasectomy after achieving optimal family size, but most respondents had never discussed it with their healthcare provider. Factors associated with vasectomy interest included being partnered, having a lower household income, and knowing someone who has had a vasectomy. Almost 50% of respondents would be interested in obtaining information about vasectomies from their obstetrician or prenatal care provider. CONCLUSIONS: Many patients and their male partners in the prenatal clinic setting were interested in vasectomy as a method for permanent contraception, but most respondents had never received counselling. Since comprehensive prenatal care includes contraceptive planning, obstetric providers are uniquely positioned to educate individuals on vasectomy.

Contraception for Women With Psychiatric Disorders.

OBJECTIVE: Mental health care for women includes decision support to prepare for major life events, including preconception planning for treatment during pregnancy and the postpartum period. The authors discuss contraceptive choices and their effectiveness, side effects, and impact on psychiatric symptoms. The Centers for Disease Control and Prevention's recommendations, Medical Eligibility Criteria for Contraceptive Use, provided the structure for review of contraceptive choices. METHODS: A search of PsycINFO, PubMed, Embase, and Scopus was conducted for publications on the management of contraception for women with mental illness. Publications were selected if they included, based on the authors' consensus, data supporting evidence-based care important for psychiatrists who treat women desiring contraceptives. RESULTS: The majority of women choose combined oral contraceptives. Although long-acting reversible contraceptives (implants, intrauterine devices) are associated with low failure rates, favorable safety profiles, rapid return to fertility after removal, and few contraindications, they are chosen by only 14% of women. All methods are acceptable for women with depression, although medical comorbidities may dictate a specific type. The impact of hormonal contraceptives on the risk for depression is controversial; however, clinical studies and randomized placebo-controlled trials of women with psychiatric disorders have generally reported similar or lower rates of mood symptoms in hormonal contraceptive users compared with nonusers. Although interactions between psychotropic drugs and contraceptives are rare, clozapine, anticonvulsants, and St. John's Wort are exceptions. CONCLUSIONS: Proactive management of mental illness, contraception, and pregnancy improves a woman's capacity to function and optimizes her mental and reproductive health.

A prospective pilot study to assess the impact of the etonogestrel implant on postpartum depression.

OBJECTIVES: To assess the feasibility of comparing the rates of positive depression screens at 6 weeks and 3 months postpartum in women using immediate postpartum etonogestrel implant (ENG-implant) and women using non-hormonal contraception or sterilisation. METHODS: This was a pilot prospective cohort study performed to test the design adequacy of comparing the rates of positive postpartum PHQ-9 screens (≥10) in women using immediate postpartum ENG-implant and women using non-hormonal contraception or sterilisation. Participants were recruited during the third trimester of pregnancy or during delivery hospitalisation. They self-allocated to one of the two comparison groups. PHQ-9 surveys were administered during the third trimester of pregnancy, immediately postpartum, and at 6 weeks and 3 months postpartum. RESULTS: Between June 2017 and March 2018, 91 patients were recruited. Of these patients, 11 were excluded and the remaining 80 were split evenly into each cohort. The women in the ENG-implant group were younger, less educated, and more often publicly insured. The percentage of participants with positive PHQ-9 screens were: 3% during the postpartum hospitalisation, 6.2% at 6 weeks postpartum, and 10.2% at 3 months postpartum. PHQ-9 scores were similar between groups at both postpartum time points. CONCLUSION: The rates of positive PHQ-9 screens at 6 weeks postpartum were similar between groups. These preliminary data suggest that immediate postpartum placement of the ENG-implant does not negatively impact the risk for a positive depression screen. Larger-scale, adequately powered studies are warranted to further investigate this finding.

Contraceptive Options Following Gestational Diabetes: Current Perspectives.

Gestational diabetes mellitus (GDM) complicates approximately 7% of pregnancies in the United States. Along with risk factors related to pregnancy, women with a history of GDM also have an increased risk of developing type 2 diabetes mellitus later in life. These women require special consideration when discussing contraception and other reproductive health issues. GDM carries a category 1 rating in the US Medical Eligibility Criteria for all contraceptive methods, which supports safety of the various methods but does not account for effectiveness. Contraceptive options differ in composition and mechanisms of action, and concerns have been raised about possible effects of contraception on metabolism. Clinical evidence is limited to suggest that hormonal contraception has significantly adverse effects on body weight, lipid, or glucose metabolism. In addition, the majority of evidence does not suggest a relationship between development of type 2 diabetes mellitus and use of hormonal contraception. Data are limited, so it is challenging to make a broad, general recommendation regarding contraception for women with a history of GDM. A woman's history of GDM should be considered during contraceptive counseling. Discussion should focus on potential medical comorbidities and the implications of GDM on future health, with special consideration of issues including bone health, obesity, cardiovascular disease, and thrombosis risk. Providers must emphasize the importance of reliable, highly effective contraception for women with GDM, to optimize the timing of future pregnancies. This approach to comprehensive counseling will guide optimal decision-making on contraceptive use, lifestyle changes, and planning of subsequent pregnancies.

Postpartum weight loss in overweight and obese women using the etonogestrel subdermal implant: a pilot study.

OBJECTIVE: To compare weight loss during the first 6months postpartum in overweight and obese women using the etonogestrel implant, placed in the immediate postpartum period, with that of controls using nonhormonal contraception, utilizing a pilot design. STUDY DESIGN: Pilot, prospective cohort study. Analysis groups were divided by body mass index (overweight: 25-29.9kg/m2; Class I Obesity: 30-34.5kg/m2; Class II Obesity: 35-39.9kg/m2) and grouped by use of etonogestrel implant or nonhormonal contraception for all outcomes. Primary outcome was the proportion of women in each group returning to pregravid weight by 6months postpartum. Secondary outcomes included waist circumference, motivation to lose weight, eating habits, physical activity, feasibility of study procedures and assessment of recruitment potential in the first 6months postpartum. RESULTS: A total of 127 women enrolled between June 2014 and August 2015. Fifty-seven chose the etonogestrel implant for immediate postpartum contraception while 70 chose nonhormonal contraceptives. Six months after delivery, about half of women in each group returned to within 1.5 kg of pregravid weight (42% etonogestrel [ENG]-implant vs. 67% nonhormonal methods, p=.19). Retention rates were high with over 75% of total study population providing study data at 6months. Two nonhormonal contraceptive users conceived in the first 4months postpartum. CONCLUSION: No statistical difference in percentage return to pregravid weight was detected between groups, but data suggest that a somewhat lower proportion of implant users lost weight at 6months. Rapid recruitment, high retention and marked acceptance of immediate ENG implant use demonstrate feasibility for a larger, adequately powered trial. IMPLICATIONS: Immediate postpartum insertion of the ENG implant is safe and effective. Study findings suggest modest interference in overweight and obese women's ability to lose gestational weight. If future research demonstrates no statistical difference, increased uptake in immediate implant use should occur in most women, including those who are overweight or obese.

The Current Status of Oral Contraceptives: Progress and Recent Innovations.

Millions of women in the United States and abroad use oral contraceptive pills. These popular contraceptives are the most common reversible birth control method in the United States, and a wide variety of pills are available for prescription. Oral contraceptives provide safe and effective protection against pregnancy and offer several noncontraceptive benefits. Over the years, advances in the laboratory and knowledge gained through epidemiologic data promoted the development of new contraceptive preparations. Generations of oral contraceptives emerged over time, containing lower doses of estrogens and new and novel progestins. The current review discusses the clinical characteristics of oral contraceptives, with emphasis on basic pharmacology and the evolution of various contraceptive formulations and regimens.

Assessment of contraceptive needs in women undergoing bariatric surgery.

OBJECTIVE: To evaluate documentation of contraception and counseling in women planning to undergo bariatric surgery. STUDY DESIGN: Chart review of 1012 women ages 18-45years presenting for bariatric surgery evaluation. Data on socio-demographic variables, documented contraceptive method, preconception counseling, gynecology referrals and postoperative pregnancies were collected. RESULTS: The charts of only 272 women (26.9%) contained documentation of a contraceptive method; the most common was oral contraceptives (n=132, 48.5%). Sixteen pregnancies were identified in the first 18months postoperatively. CONCLUSIONS: Currently, the documentation of contraceptive counseling is lacking in clinical practice. Measures to enhance provider and patient awareness of these issues will improve patient care. IMPLICATIONS: Pregnancy planning and documentation of perioperative contraceptive use in women undergoing bariatric surgery are suboptimal, placing these women at risk of unintended pregnancies. Future research should delineate the best practices in contraceptive provision in this high-risk population of women.

Implementation and evaluation of a dilation and evacuation simulation training curriculum.

OBJECTIVES: To evaluate obstetrics and gynecology resident physicians' performance following a simulation curriculum on dilation and evacuation (D&E) procedures. STUDY DESIGN: This study included two phases: simulation curriculum development and resident physician performance evaluation following training on a D&E simulator. Trainees participated in two evaluations. Simulation training evaluated participants performing six cases on a D&E simulator, measuring procedural time and a 26-step checklist of D&E steps. The operative training portion evaluated residents' performance after training on the simulator using mastery learning techniques. Intra-operative evaluation was based on a 21-step checklist score, Objective Structured Assessment of Technical Skills (OSATS), and percentage of cases completed. RESULTS: Twenty-two residents participated in simulation training, demonstrating improved performance from cases one and two to cases five and six, as measured by checklist score and procedural time (p<.001 and p=.001, respectively). Of 10 participants in the operative training, all performed at least three D&Es, while seven performed at least six cases. While checklist scores did not change significantly from the first to sixth case (mean for first case: 18.3; for sixth case: 19.6; p=.593), OSATS ratings improved from case one (19.7) to case three (23.5; p=.001) and to case six (26.8; p=.005). Trainees completed approximately 71.6% of their first case (range: 21.4-100%). By case six, the six participants performed 81.2% of the case (range: 14.3-100%). CONCLUSIONS: D&E simulation using a newly-developed uterine model and simulation curriculum improves resident technical skills. Simulation training with mastery learning techniques transferred to high level of performance in OR using checklist. The OSATS measured skills and showed improvement in performance with subsequent cases. IMPLICATIONS: Implementation of a D&E simulation curriculum offers potential for improved surgical training and abortion provision.

Postpartum glucose tolerance in women with gestational diabetes using levonorgestrel intrauterine contraception.

OBJECTIVE: Postpartum contraception is critical in women with gestational diabetes mellitus (GDM). We evaluated the effect of the levonorgestrel intrauterine system (LNG-IUS) on glucose tolerance in postpartum women with GDM. STUDY DESIGN: The study is a descriptive analysis of 12-month glucose tolerance in women with recent GDM who used the LNG-IUS, the copper IUD or postpartum sterilization. RESULTS: Twelve months postpartum, 3 of 13 LNG-IUS users (23.1%) and 1 of 6 nonhormonal contraceptive users (16.6%) had prediabetes. No woman developed overt diabetes. CONCLUSIONS: This study is the first and only to measure the metabolic effects of the LNG-IUS women with GDM. Larger trials are necessary. IMPLICATIONS: Use of levonorgestrel intrauterine contraception does not appear to negatively affect glucose tolerance in postpartum women with a history of gestational diabetes. Additional appropriately powered clinical studies are needed to confirm these results.

Labor induction outcomes in third-trimester stillbirths.

OBJECTIVE: To describe the management of third-trimester stillbirth at a single institution, stratifying induction intervals and adverse outcomes by method. METHODS: Women diagnosed with fetal demise at 28weeks or later and admitted to an academic hospital between January 2007 and September 2010 were identified. A chart review extracted demographics, history, induction method, delivery interval, and adverse outcomes. RESULTS: Seventy-four women were included, with a median gestational age of 35.5weeks (range, 28-40weeks). Ten women had undergone at least 1 prior cesarean. Induction methods included misoprostol alone or for cervical ripening; oxytocin and amniotomy; transcervical Foley catheter; and mifepristone. Overall, 88% of patients delivered within 24hours; median time to fetal delivery was 11hours 20minutes (range, 7minutes to 57hours 12minutes). Adverse outcomes included intrapartum fever and postpartum hemorrhage. In total, 98% of patients, including those with prior cesarean, had a successful vaginal delivery. CONCLUSION: Regardless of third-trimester induction method for management of stillbirth, the majority of women experience safe delivery within 24hours. The descriptive data imply that misoprostol-only inductions might confer the shortest induction intervals; however, further prospective trials are needed to identify the optimal misoprostol regimen for women with third-trimester stillbirth.

Recurrent massive perivillous fibrin deposition in the placenta associated with fetal renal tubular dysgenesis: case report and literature review.

Massive perivillous fibrin deposition (MPVFD) of the placenta and renal tubular dysgenesis (RTD) are relatively rare diseases with potential recurrent risks that have not previously associated in the literature. Herein, we report the clinical course, autopsy findings, and placental pathologic features from 3 consecutive pregnancies delivered in 1 woman, all showing recurrent MPVFD in the placenta and RTD in the bilateral fetal kidneys.

Team-based learning: a novel approach to medical student education in family planning.

BACKGROUND: Medical schools are increasingly using team-based learning (TBL). We compared medical student satisfaction and understanding of key concepts in family planning following TBL and traditional lectures. STUDY DESIGN: During the OB/GYN clinical rotation orientation, third year medical students completed a pretest in family planning. Students in the odd-numbered clerkships participated in TBL, and students in the even-numbered clerkships participated in lectures. Both groups of students completed a posttest and satisfaction survey. RESULTS: A total of 130 students participated in this study. Sixty-nine students were in the TBL group, and 61 students were in the lecture group. The TBL group reported higher scores when asked if the learning style was a valuable experience (p=.045), helped them learn the course material (p=.01) and improved problem-solving skills (p=.04). Both groups gained significant amount of knowledge (p<.001) as calculated by the Student's paired t test. The change in scores was not significantly different between the groups (p=.73), as calculated using the Student's unpaired t test. CONCLUSION: As a learning strategy for family planning, TBL resulted in high student satisfaction. This is the first study to evaluate this innovative teaching style for medical student education in family planning.

Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block.

BACKGROUND: This study was conducted to investigate the effects of a 1% lidocaine paracervical block on perceived patient pain during intrauterine device (IUD) insertion. STUDY DESIGN: We randomized 50 women undergoing IUD insertion to receive either a 10-mL 1% lidocaine paracervical block or no local anesthetic before IUD insertion. Women marked their pain on a 100-mm visual analogue scale (VAS) (0 mm = no pain, 100 mm = worst pain possible) at various points of the procedure (speculum insertion, tenaculum placement, paracervical block administration, IUD insertion and 5 min postprocedure). RESULTS: Twenty-six women received the paracervical block before IUD insertion, and 24 received no local anesthesia. Groups were similar in age, parity, ethnicity, education and complications. Women who received the paracervical block reported a median VAS score of 24.0 mm with IUD insertion, and women who did not receive local anesthetic reported a median VAS score of 62.0 mm with IUD insertion; p=.09. CONCLUSION: Compared with no anesthetic, a 1% lidocaine paracervical block did not result in a statistically significant decrease in perceived pain with IUD insertion.

Estradiol valerate and dienogest: a new approach to oral contraception.

Most combination oral contraceptives contain ethinyl estradiol and a progestin. A new and novel oral contraceptive formulation combines estradiol valerate (E2V) with dienogest (DNG) in a four-phase dosing regimen. 17ß-estradiol is a naturally-occurring estrogen, and a contraceptive pill containing such an estrogen offers potential benefits with regard to metabolic side effects and adverse events. Dienogest is derived from 19-nortestosterone and exerts profound progestational effects on the endometrium, but it differs from other progestins in its class by its antiandrogenic activity. Estradiol valerate plus dienogest (E2V/DNG) is now available in a four-phasic regimen that integrates an estrogen stepdown and progestin stepup dosing approach along with a short two-day hormone-free interval. This regimen offers safe, reliable contraception and has been shown to be an effective treatment for heavy menstrual bleeding. Metabolic effects and adverse events appear similar to those reported with oral contraceptives containing ethinyl estradiol.

The lowest-dose, extended-cycle combined oral contraceptive pill with continuous ethinyl estradiol in the United States: a review of the literature on ethinyl estradiol 20 µg/levonorgestrel 100 µg + ethinyl estradiol 10 µg.

Extended-cycle oral contraceptives (OCs) are increasing in popularity in the United States. A new extended-cycle OC that contains the lowest doses of ethinyl estradiol (EE) and levonorgestrel (LNG) + continuous EE throughout the cycle is now available. It provides 84 days of a low-dose, combined active pill containing levonorgestrel 100 µg and ethinyl estradiol 20 µg. Instead of 7 days of placebo following the active pills, the regimen delivers 7 days of ethinyl estradiol 10 µg. Existing studies reveal a similar efficacy and adverse effect profile compared with other extended-regimen OCs. Specifically, the unscheduled bleeding profile is similar to other extended-cycle OCs and improves with the increase in the duration of use. Although lower daily doses of hormonal exposure have potential benefit, to our knowledge, there are no published studies indicating that this specific regimen offers a lower incidence of hormone-related side effects or adverse events. In summary, this new extended-cycle OC provides patients a low-dose, extended-regimen OC option without sacrificing efficacy or tolerability.