Anne E. Burke

Impact of bariatric surgery on hypertensive disorders in pregnancy: retrospective analysis of insurance claims data.

Objective To determine whether women who had a delivery after bariatric surgery have lower rates of hypertensive disorders in pregnancy compared with women who had a delivery before bariatric surgery. Design Retrospective cohort study. Setting Claims data for 2002-6 from seven insurance plans in the United States. Participants 585 women aged 16-45 who had undergone bariatric surgery, had at least one pregnancy and delivery, and had continuous insurance coverage during pregnancy plus two weeks after delivery. Main outcome measure Hypertensive disorders in pregnancy defined with ICD-9 codes. The independent variable was the timing of delivery in relation to bariatric surgery, classified as deliveries before and after surgery. We used logistic regression to calculate odds ratios and confidence intervals for each type of hypertensive disorder in pregnancy. Results Among the 585 women who had undergone bariatric surgery and had a delivery, 269 delivered before surgery and 316 delivered after surgery. Gastric bypass was the surgery in 82% (477) of all women. Women who delivered before surgery were younger at the time of delivery (mean age 31.3 v 32.5) but had higher rates of pre-existing diabetes and gestational diabetes mellitus. Compared with women who delivered before surgery, women who delivered after surgery had substantially lower rates of pre-eclampsia and eclampsia (odds ratio 0.20, 95% confidence interval 0.09 to 0.44), chronic hypertension complicating pregnancy (0.39, 0.20 to 0.74), and gestational hypertension (0.16, 0.07 to 0.37), even after adjustment for age at delivery, multiple pregnancy (that is, twins or more), surgical procedure, pre-existing diabetes, and insurance plan. Conclusion In this retrospective analysis of US women, bariatric surgery was associated with lower rates of hypertensive disorders in subsequent pregnancy.

Reduced Incidence of Gestational Diabetes with Bariatric Surgery

BACKGROUNDnObesity is a risk factor for gestational diabetes mellitus (GDM), and bariatric surgery is an effective treatment for obesity. Our objective was to determine the association of bariatric surgery with the incidence of GDM and related complications.nnnSTUDY DESIGNnWe performed a retrospective study comparing rates of GDM and related outcomes (including cesarean section, large-for-gestational-age infant, shoulder dystocia, and infection) between a group of women with a delivery before bariatric surgery and a group with a delivery after bariatric surgery. We used a private insurance claims database with information on 23,594 women who had bariatric surgery between 2002 and 2006. The dataset was searched to identify women with codes for bariatric surgery and a pregnancy resulting in a delivery at greater than 22 weeks gestation. Incidences of GDM and selected delivery complications for delivery before versus after bariatric surgery were compared using Fisher exact test and logistic regression.nnnRESULTSnThere were 346 women who had a delivery before bariatric surgery, and 354 had a delivery after bariatric surgery. Women with delivery after bariatric surgery had lower incidences of GDM (8% vs 27%, odds ratio (OR) 0.23, (95% CI 0.15 to 0.36) and cesarean section (28% vs 43%, OR0.53, 95% CI 0.39 to 0.72) than those with delivery before bariatric surgery.nnnCONCLUSIONSnBariatric surgery is associated with a decreased incidence of GDM and cesarean section in subsequent pregnancies. This potential effect of bariatric surgery should be considered in the management of obese women of childbearing age. Prospective studies are needed to confirm these findings.

Contraception for the HIV-Positive Woman: A Review of Interactions between Hormonal Contraception and Antiretroviral Therapy

Background. Preventing unintended pregnancy in HIV-positive women can significantly reduce maternal-to-child HIV transmission as well as improve the womans overall health. Hormonal contraceptives are safe and effective means to avoid unintended pregnancy, but there is concern that coadministration of antiretroviral drugs may alter contraceptive efficacy. Materials and Methods. We performed a literature search of PubMed and Ovid databases of articles published between January 1980 and February 2012 to identify English-language reports of drug-drug interactions between hormonal contraceptives (HCs) and antiretroviral drugs (ARVs). We also reviewed the FDA prescribing information of contraceptive hormone preparations and antiretrovirals for additional data and recommendations. Results. Twenty peer-reviewed publications and 42 pharmaceutical package labels were reviewed. Several studies of combined oral contraceptive pills (COCs) identified decreased serum estrogen and progestin levels when coadministered with certain ARVs. The contraceptive efficacy of injectable depot medroxyprogesterone acetate (DMPA) and the levonorgestrel intrauterine system (LNG-IUS) were largely unaffected by ARVs, while data on the contraceptive patch, ring, and implant were lacking. Conclusions. HIV-positive women should be offered a full range of hormonal contraceptive options, with conscientious counseling about possible reduced efficacy of COCs and the contraceptive implant when taken with ARVs. DMPA and the LNG-IUS maintain their contraceptive efficacy when taken with ARVs.

Predictors and perception of pain in women undergoing first trimester surgical abortion

BACKGROUNDnThe aim of the study was to evaluate pain and predictors of pain in women undergoing electric (EVA) or manual vacuum aspiration (MVA) for first trimester surgical abortions and to examine how perceptions of pain differ among participants, advocates (participant support person) and physicians.nnnSTUDY DESIGNnIn this randomized controlled study, women presenting for first trimester abortion underwent standardized EVA or MVA. Participants completed questionnaires, visual analog scales (VAS) and Likert scales for pain. Logistic and linear regression models were used to analyze the data.nnnRESULTSnNonwhite women and women who preoperatively expected more pain reported higher procedure-related pain scores. Vacuum source, previous history of abortion, comfort with decision to have an abortion and partner involvement did not affect participant pain scores. In the multivariable analyses, no single factor predicted procedure-associated pain. The advocates perceived that more educated women had less pain. Physicians felt longer procedures and a womans fear of pelvic examinations caused more pain. Physicians believed women had less pain than the participants reported themselves (p<.001). Only physicians thought that EVA was less painful than MVA (p<.01).nnnCONCLUSIONnDistinct factors other than vacuum source affect the perception of abortion-related pain. Understanding these factors may help inform counseling strategies aimed at ameliorating pain perception during first trimester abortions.

Paracervical Block With Combined Ketorolac and Lidocaine in First-Trimester Surgical Abortion: A Randomized Controlled Trial

OBJECTIVE: To study the effects of a paracervical block with combined ketorolac and lidocaine on perceived pain during first-trimester surgical abortion. METHODS: A double-masked, placebo-controlled, randomized clinical trial of 50 women undergoing first-trimester surgical abortions (before 11 weeks of gestation) received either oral ibuprofen with a lidocaine-alone paracervical block or an oral placebo and paracervical block with combined ketorolac and lidocaine. Women completed a series of 100-mm visual analog scales (anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain (anticipated pain, pain during and after surgical abortion, and total satisfaction). RESULTS: Twenty-five women received preoperative oral ibuprofen followed by paracervical block with lidocaine alone, and 25 received oral placebo followed by paracervical block with combined ketorolac and lidocaine. Groups were similar with respect to sociodemographic variables. Women who received paracervical block with combined ketorolac and lidocaine reported significantly less pain after cervical dilation (59.8 compared with 74.8 mm, P<.05). The groups did not differ in perceived procedure-related or postoperative pain. There was no difference in overall satisfaction with pain control between the two groups (63.6 compared with 62.9 mm, P=.93). CONCLUSION: Paracervical block with combined ketorolac and lidocaine significantly decreases perceived pain associated with cervical dilation during first-trimester surgical abortion. This analgesic mixture may be offered as an alternative pain regimen to women seeking first-trimester surgical abortion. It may also offer improved pain control in other gynecologic procedures necessitating cervical dilation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00617097. LEVEL OF EVIDENCE: I

Successful management of second-trimester postabortion hemorrhage with an intrauterine tamponade balloon.

BACKGROUND: Legally induced abortion is a safe procedure. However, hemorrhage is a significant cause of abortion-related morbidity and mortality. We describe a case in which a uterine tamponade balloon was successfully used to control a second-trimester postabortion hemorrhage. CASE: A gravida 1 para 0 woman underwent dilation and evacuation at 18 weeks of gestation for fetal aneuploidy. Her procedure was complicated by intraoperative hemorrhage not resulting from uterine atony. This was successfully managed by tamponade with a large intrauterine balloon. CONCLUSION: Uterine balloon tamponade should be considered in the management of second-trimester postabortion hemorrhage unresponsive to medical therapy.

Update on medical abortion: Simplifying the process for women

Purpose of review Medical abortion using mifepristone and misoprostol comprises a growing proportion of abortions performed in the United States. Simplifying the process of medical abortion can optimize use of resources and improve care for women. Recent findings Medical abortion using evidence-based protocols is effective through 70 days’ gestation. The requirement of a follow-up office visit with a transvaginal ultrasound to ensure completion of medical abortion is safely and effectively replaced with self-administered low-sensitivity or semiquantitative urine pregnancy tests and remote communication with women. Most contraceptive options can be initiated the same day as mifepristone administration to improve contraceptive use after medical abortion. State legislatures continue to pass laws that threaten evidence-based medical abortion practices. Such efforts ultimately limit access to well-tolerated and effective medical abortion services. Summary Research supports simplification of the follow-up protocol for medical abortion, and provision of the contraceptive implant and progestin injectable for postabortion contraception the same day as mifepristone administration. With disregard to its documented safety and efficacy, legislative challenges persist as significant challenges to provision of evidence-based medical abortion.

Interruption of nonviable pregnancies of 24–28 weeks' gestation using medical methods

The need to interrupt a pregnancy between 24 and 28 weeks of gestation is uncommon and is typically due to fetal demise or lethal anomalies. Nonetheless, treatment options become more limited at these gestations, when access to surgical methods may not be available in many circumstances. The efficacy of misoprostol with or without mifepristone has been well studied in the first and earlier second trimesters of pregnancy, but its use beyond 24 weeks gestation is less well described. This document attempts to synthesize the existing evidence for the use of misoprostol with or without mifepristone to induce labor for nonviable pregnancies at gestations of 24-28 weeks. The composite evidence suggests that a regimen combining mifepristone and misoprostol may shorten the time to expulsion, though the overall success rates are similar to those seen with misoprostol-only regimens.

Continuous dosing of a novel contraceptive vaginal ring releasing Nestorone® and estradiol: Pharmacokinetics from a dose-finding study

BACKGROUNDnAs part of a program to develop a novel estradiol-releasing contraceptive vaginal ring (CVR), we evaluated the pharmacokinetic (PK) profile of CVRs releasing segesterone acetate (Nestorone® (NES)) combined with one of three different estradiol (E2) doses.nnnSTUDY DESIGNnA prospective, double-blind, randomized, multi-centered study to evaluate a 90-day CVR releasing NES [200mcg/day] plus E2, either 10mcg/day, 20mcg/day, or 40mcg/day in healthy reproductive-age women with regular cycles. Participants provided blood samples twice weekly for NES and E2 levels during the first 60 days (ring 1) and the last 30 days (ring 2) of use. A subset underwent formal PK assessments at ring initiation, ring exchange (limited PK), and study completion.nnnRESULTSnThe main study enrolled 197 women; 22 participated in the PK substudy. Baseline characteristics between the main and PK participants were comparable, with an average BMI of 25.8 kg/m2 (SD 4.3). In the PK substudy, all three rings showed similar NES PK: mean area under the curve (AUC(0-72)) 34,181 pg*day/mL; concentration maximum (Cmax) 918 pg/mL; time to maximum concentration (Tmax) 3.5 h. For E2, the Cmax occurred at 2 h, and was significantly higher with the 20 mcg/day ring (mean 390 pg/mL); 10 mcg/day, 189 pg/mL, p=.003; 40 mcg/day, 189 pg/mL, p<.001), and declined rapidly to≤50 pg/mL for all doses by 24 h. For all subjects, the median E2 levels remained under 35 pg/mL during treatment.nnnCONCLUSIONnPK parameters of NES were not affected when paired with different doses of E2, but E2 levels from all three doses were lower than anticipated and no dose response was observed.nnnIMPLICATIONSnWhile these novel estradiol-releasing combination contraceptive vaginal rings provided sustained release of contraceptive levels of Nestorone over 90 days, the E2 levels achieved were not consistent with bone protection, and a dose-response was not observed.

Brief Report: Robo1 Regulates the Migration of Human Subventricular Zone Neural Progenitor Cells During Development

Human neural progenitor cell (NPC) migration within the subventricular zone (SVZ) of the lateral ganglionic eminence is an active process throughout early brain development. The migration of human NPCs from the SVZ to the olfactory bulb during fetal stages resembles what occurs in adult rodents. As the human brain develops during infancy, this migratory stream is drastically reduced in cell number and becomes barely evident in adults. The mechanisms regulating human NPC migration are unknown. The Slit–Robo signaling pathway has been defined as a chemorepulsive cue involved in axon guidance and neuroblast migration in rodents. Slit and Robo proteins expressed in the rodent brain help guide neuroblast migration from the SVZ through the rostral migratory stream to the olfactory bulb. Here, we present the first study on the role that Slit and Robo proteins play in human‐derived fetal neural progenitor cell migration (hfNPC). We describe that Robo1 and Robo2 isoforms are expressed in the human fetal SVZ. Furthermore, we demonstrate that Slit2 is able to induce a chemorepellent effect on the migration of hfNPCs derived from the human fetal SVZ. In addition, when Robo1 expression is inhibited, hfNPCs are unable to migrate to the olfactory bulb of mice when injected in the anterior SVZ. Our findings indicate that the migration of human NPCs from the SVZ is partially regulated by the Slit–Robo axis. This pathway could be regulated to direct the migration of NPCs in human endogenous neural cell therapy. Stem Cells 2017;35:1860–1865