Misoprostol with balloon vs oxytocin with balloon in high-risk pregnancy induction: a randomized controlled trial.

BACKGROUND: Pregnancies at high risk for maternal, fetal, or placental complications often necessitate induction of labor in the late preterm or early term period for delivery. Limited data exist on the safest method of induction to use in this specific patient population. OBJECTIVE: This study aimed to compare the combination of oxytocin plus a Cook balloon vs misoprostol plus a Cook balloon for induction of labor in high-risk pregnancies. STUDY DESIGN: We conducted an open-label, randomized controlled trial at a single institution from July 2020 to May 2022. The study was approved by the institutional review board and registered with ClinicalTrials.gov (NCT04492072). Individuals with a high-risk pregnancy, at least ≥22 weeks' gestation, with a singleton in cephalic presentation, Bishop score ≤6, and intact membranes were offered enrollment. A high-risk pregnancy was defined as a pregnancy with any of the following complications: hypertensive disease of pregnancy, fetal growth restriction, oligohydramnios, suspected placental abruption requiring delivery, uncontrolled pregestational diabetes, or abnormal biophysical profile or nonstress test requiring delivery. The primary outcome was the rate of cesarean delivery. Secondary maternal outcomes included induction to delivery interval, number of vaginal deliveries within 24 hours, rates of uterine tachysystole, intraamniotic infection, operative vaginal delivery, and postpartum hemorrhage. Secondary fetal outcomes included fetal heart rate abnormalities, stillbirth, Apgar scores <7 at 5 minutes, admission to the neonatal intensive care unit, arterial umbilical blood pH <7.1, sepsis, and neonatal death. A subgroup analysis was planned for the primary outcome to assess the different indications for cesarean delivery. An intent-to-treat analysis was performed. RESULTS: During the 22 months of the trial, a total of 150 patients were randomized, and 73 (49%) of those were induced with oxytocin and a Cook balloon and 77 (51%) were induced with misoprostol and a Cook balloon. There was no significant difference in the overall rate of cesarean delivery between the study groups, (21.9% vs 31.1%; relative risk, 0.70; 95% confidence interval, 0.41-1.21), nor among those for which the cesarean delivery was performed for a specific indication. There were no differences in the secondary maternal and fetal or neonatal adverse outcomes. CONCLUSION: In high-risk pregnancies, the rate of cesarean delivery and adverse maternal and fetal outcomes were similar for induction of labor with oxytocin and a Cook balloon and for induction with misoprostol and a Cook balloon.

Prostaglandins for induction in pregnancies with fetal growth restriction.

BACKGROUND: The data on safety of prostaglandin agents for induction of pregnancies with fetal growth restriction is limited. OBJECTIVE: To compare the rates of adverse outcomes among pregnancies with fetal growth restriction undergoing induction of labor with and without prostaglandins STUDY DESIGN: We performed a propensity-score-based secondary analysis of the Consortium on Safe Labor database. We included term, singleton, and nonanomalous pregnancies with fetal growth restriction (estimated fetal weight <10th percentile for gestational age). We excluded previous cesarean deliveries. The primary exposure was induction using prostaglandins (prostaglandin E1 or prostaglandin E2) compared with other methods. The primary outcome was a composite of adverse neonatal outcomes. The secondary outcomes included all cesarean deliveries and cesarean deliveries for nonreassuring fetal heart tracings. A subgroup analysis comparing the type of prostaglandin was planned a priori. The results are expressed as adjusted odds ratios with 95% confidence intervals. RESULTS: Of 756 (0.3%) inductions, 212 (28%) used prostaglandins (108 prostaglandin E1, 94 prostaglandin E2), and 553 (72%) used nonprostaglandin methods, including oxytocin (348, 63%), amniotomy (211, 38%), and/or mechanical dilation (9, 1%). There were no differences in the composite of adverse neonatal outcomes between the prostaglandin (10.4%) and the nonprostaglandin group (6.7%), adjusted odds ratio, 1.39 (0.64-3.03). The rate of cesarean delivery was higher in the inductions that received prostaglandins than those that did not (25.5% vs 14.8%, adjusted odds ratio, 1.80; 1.07-3.02). The rate of cesarean delivery for nonreassuring fetal heart tracings was higher for those that received prostaglandins than those that did not (16.0% vs 8.7%, adjusted odds ratio, 2.37; 1.28-4.41). When prostaglandin E1 and prostaglandin E2 were examined independently, there were similar increases in the composite of adverse neonatal outcomes and cesarean delivery rates for both prostaglandin E1 and prostaglandin E2 compared with nonprostaglandin controls. CONCLUSION: There were no differences in the composite of adverse neonatal outcomes when prostaglandins were used for induction in pregnancies with fetal growth restriction compared with other methods. However, there was a higher rate of cesarean delivery and cesarean delivery indicated for nonreassuring fetal heart tracings when prostaglandins (both prostaglandin E1 and prostaglandin E2) were used, compared with nonprostaglandin methods.

Uterine tachysystole: a survey of CAOG members suggests persistent ambiguity.

OBJECTIVES: Uterine tachysystole (TS) has been defined by the American College of Obstetrics and Gynecologists (ACOG) as "more than five contractions in 10 minutes, averaged over a 30-minute window". The objective of this study was to survey all active members of the Central Association of Obstetricians and Gynecologists (CAOG) in order to assess the obscurity behind the definition of TS as well as the management. STUDY DESIGN: The survey listed 16 questions consisting of demographics, definitions of TS, management of five hypothetical clinical cases (HCC), their personal experience, and adverse outcomes. This survey was delivered to all active members of CAOG. A priori, we considered the terminology and management to be consistent if at least 75% of the respondents were concordant in their answers. RESULTS: There was no consistency in the answers that pertained to the definition of tachysystole nor to the questions regarding the next step in management in the hypothetical clinical cases. When the MFM and generalists answers were analyzed, there were no statistically significant differences in their individual answers. CONCLUSION: This is the first survey publication on uterine tachysystole and is notable for inconsistency in the definition, frequency with which it is encountered and hypothetical management of TS. The divergent response suggests that ambiguity regarding tachysystole persists, despite ACOG attempts to rectify it.

Retracted articles in the obstetrics literature: lessons from the past to change the future.

BACKGROUND: The publication of invalid scientific findings may have profound implications on medical practice. As the incidence of article retractions has increased over the last 2 decades, organizations have formed, including Retraction Watch, to improve the transparency of scientific publishing. At present, the incidence of article retraction in the obstetrics and maternal-fetal medicine literature is unclear. OBJECTIVE: This study aimed to determine the number of retracted articles within the obstetrics and maternal-fetal medicine literature from the PubMed and Retraction Watch databases and examine reasons for retraction. STUDY DESIGN: A retrospective review of the PubMed and Retraction Watch databases was performed to identify retracted articles in the obstetrics and maternal-fetal medicine literature from indexation through December 31, 2019. The primary outcome was defined as the number of identified articles and reason for retraction. Within PubMed, articles were identified using a medical subheading search for articles categorized as withdrawn or retracted. In addition, the Retraction Watch database was queried and nonobstetrical articles were excluded. The reason for retraction was classified according to the categories listed in Retraction Watch. The subject matter was classified on the basis of the Society for Maternal-Fetal Medicine criteria. Data were collected from retracted articles for author name, country, journal name and impact factor, year of publication and retraction, study type, and response of the publishing journal. Descriptive statistics were performed. RESULTS: Of the 519 obstetrics and gynecology articles in Retraction Watch, 122 (23.5%) were specific to the obstetrics and maternal-fetal medicine specialties. In addition, 39 (32.0%) were identified from PubMed, all of which were included in Retraction Watch. There was a median time to retraction of 1 (range, 0-17) year, with a median of 3 citations per article (range, 0-145). In addition, the median journal impact factor was 2.2 (range, 0.1-27.6), with median first and senior author Hirsch index values of 6.0 and 13.5, respectively. Most articles were original research (n=80; 65.6%), specifically retrospective studies (n=11; 9.0%), case reports (n=19; 15.6%), prospective studies (n=18; 14.8%), randomized controlled trials (n=11; 9%), basic science (n=18; 14.8%), and systematic review or meta-analysis (n=3; 2.5%). Of eligible articles, 32 (26.2%) were published in journals with an impact factor ≥4, and 21 articles (17.2%) were published in the top 10 leading impact factor obstetrics and gynecology journals. Most retractions were for content-related issues (n=87; 71.3%), including 21.3% (n=26) for article duplication, 18.9% (n=23) for plagiarism, and 16.4% (n=20) for errors in results or methods. Additional reasons included author misconduct (n=12; 9.8%), nonreproducible results (n=11; 9.0%), and falsification (n=8; 6.6%). The most common journal response was an issued statement of retraction (n=82; 67.2%). Lack of retraction notice and limited to no information provided by the publishing journal occurred in 19 retracted articles (15.6%). CONCLUSION: In the obstetrics and maternal-fetal medicine literature, retraction of scientific articles is increasing and is most often related to scientific misconduct, including article duplication and plagiarism. Improved prevention and detection are warranted by journals and healthcare institutions to ensure that invalid findings are not perpetuated in the medical literature, thereby avoiding adverse consequences for maternal and perinatal care.

Routine third-trimester ultrasound in low-risk pregnancies and perinatal death: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to determine whether routine third-trimester ultrasounds in low-risk pregnancies decrease the rate of perinatal death compared with regular antenatal care with serial fundal height measurements. DATA SOURCES: This was a systematic review and meta-analysis of randomized control trials to identify relevant studies published from inception to October 2019. The databases used were Ovid, PubMed, Scopus, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials using a combination of key words related to "third trimester ultrasound" and "low-risk." STUDY ELIGIBILITY CRITERIA: We included all randomized control trials of singleton, nonanomalous low-risk pregnancies that were randomized to either one or more third-trimester ultrasounds (ultrasound group) or serial fundal height (fundal height group). Exclusion criteria were patients with multiple gestations, maternal medical complications, or fetal abnormalities requiring a third-trimester ultrasound. STUDY APPRAISAL AND SYNTHESIS METHODS: The primary outcome was the rate of perinatal death. The secondary outcomes were rates of fetal growth restriction, suspected large for gestational age, polyhydramnios, oligohydramnios, fetal anomalies, antenatal interventions, stillbirth, neonatal death, cesarean delivery, induction of labor, and other neonatal outcomes. This meta-analysis was performed with the use of the random effects model of DerSimonian and Laird to produce relative risk or mean difference with a corresponding 95% confidence interval. RESULTS: A total of 7 randomized control trials with 23,643 participants (12,343 in the ultrasound group vs 11,300 in the fundal height group) were included. The total rate of perinatal death was similar among the groups (41 of 11,322 [0.4%] vs 34 of 10,285 [0.3%]; relative risk, 1.14; 95% confidence interval, 0.68-1.89). The rate of fetal growth restriction was higher in the ultrasound group (763 of 10,388 [7%] vs 337 of 9021 [4%]; relative risk, 2.11; 95% confidence interval, 1.86-2.39) and the rate of suspected large for gestational age (1060 of 3513 [30%] vs 375 of 3558 [11%]; relative risk, 2.84; 95% confidence interval, 2.6-3.2). Polyhydramnios was also significantly higher in the ultrasound group than the fundal height group (18 of 323 [6%] vs 4 of 322 [1%] relative risk, 3.93; 95% confidence interval, 1.4-11). The rates of the remainder of the secondary outcomes were similar among the groups. CONCLUSION: Routine third-trimester ultrasounds do not decrease the rate of perinatal death compared with serial fundal height in low-risk pregnancies. Ideally, an adequately powered trial is warranted to determine whether perinatal mortality in the fundal height group can be reduced by one-third with third-trimester ultrasound.

Persistence and Extent of Neonatal Brachial Plexus Palsy: Association with Number of Maneuvers and Duration of Shoulder Dystocia.

Objective The main objective of this article is to determine if persistence of neonatal brachial plexus palsy (NBPP) following shoulder dystocia was associated with maneuvers used or duration of impacted shoulder. Study Design Retrospective review of children with NBPP and documented shoulder dystocia. Student t -tests and chi-squared tests were used to compare outcomes when shoulder dystocia resolved with > 3 versus ≤ 3 maneuvers or duration > versus ≤ 120 seconds. Relative risk (RR) with 95% confidence intervals (CI) was calculated. Results Among 46 children with NBPP and shoulder dystocia, incidence of persistence was significantly higher at 2 years of age when > 3 versus ≤ 3 maneuvers were used (100 vs. 62%; RR: 1.6, 95% CI: 1.2-2.2). When resolution of impacted shoulder lasted >120 versus ≤ 120 seconds, NBPP at 2 years was significantly more likely (100 vs. 63%; RR: 1.6, 95% CI: 1.1-2.2). Injury to all five nerves of the brachial plexus was more likely if standard deviation lasted > 120 versus ≤ 120 seconds (RR: 2.2; 95% CI: 1.03-4.6). Conclusion Though the number of maneuvers used and duration of shoulder dystocia are associated with persistence of NBPP, the retrospective nature of the study of a selective cohort precludes recommendations changing the current management of shoulder dystocia.

Sonographic Estimated Fetal Weight among Diabetics at ≥ 34 Weeks and Composite Neonatal Morbidity.

Objectives The objective was to assess the composite neonatal morbidity (CNM) among diabetic women with sonographic estimated fetal weight (SEFW) at 10 to 90th versus >90th percentile for gestational age (GA). Study Design The inclusion criteria for this retrospective study were singleton pregnancies at 34 to 41 weeks, complicated by diabetes, and that had SEFW within 4 weeks of delivery. Odds ratios (ORs) with 95% confidence intervals (CI) were calculated. Results Among the 140 cohorts that met the inclusion criteria, 72% had SEFW at 10th to 90th percentile for GA, and 28% at >90th percentile. Compared with women with diabetes with last SEFW at 10th to 90th percentile, those with estimate > 90th percentile for GA had a significantly higher rate of CNM (13 vs. 28%; OR, 2.65; 95% CI, 1.07-6.59). Among 109 diabetic women who labored, the rate of shoulder dystocia was significantly higher with SEFW at >90th percentile for GA than those at 10th to 90th percentile (25 vs. 2%; p = 0.002); the corresponding rate of CNM was 29 versus 10% ( p = 0.02). Conclusion Among diabetic women with SEFW > 90th percentile for GA, CNM was significantly higher than in women with estimate at 10 to 90th percentile. Despite the increased risk of CNM, these newborns did not have long-term morbid sequela.

Sonographic Examination of The Fetus Vis-à-Vis Shoulder Dystocia: A Vexing Promise.

Since antepartum and intrapartum risk factors are poor at identifying women whose labor is complicated by shoulder dystocia, sonographic examination of the fetus holds promise. Though there are several measurements of biometric parameters to identify the parturient who will have shoulder dystocia, none are currently clinically useful. Three national guidelines confirm that sonographic measurements do not serve as appropriate diagnostic tests to identify women who will have shoulder dystocia with or without concurrent injury. In summary, biometric measurements of the fetus should not be used to alter clinical management with the aim of averting shoulder dystocia.

Successful treatment of Candida osteoarticular infections with limited duration of antifungal therapy and orthopedic surgical intervention.

BACKGROUND: Current guidelines for treatment of Candida osteoarticular infections (COAIs) recommend a prolonged course of antifungal therapy (AFT) of 6-12 months. Based upon strategies developed at the Hospital for Special Surgery (HSS), we hypothesized that the duration of antifungal therapy may be substantially reduced for management of COAI. METHODS: This was a retrospective chart review of cases of COAI treated at the HSS for the past 14 years. COAI was documented by open biopsy and direct culture in all cases. The mean (95% confidence interval, CI) duration of documented follow-up was 39 (16-61) months. RESULTS: Among the 23 cases of COAI, the median age was 62 years (range 22-83 years) with 61% having no underlying condition. Orthopedic appliances, including joint prostheses and fracture hardware, were present in 74% of cases. All patients had COAI as the first proven site of candidiasis. Candida albicans and Candida parapsilosis were the most common species. Hip, knee, foot, and ankle were the most common sites. All patients received aggressive surgical intervention followed by AFT administered for a mean (95% CI) duration of 45 (38-83) days. Systemic AFT consisted principally of fluconazole alone (65%) or in combination with other agents (26%). Adjunctive intraoperative amphotericin B irrigation was used in 35%. Among eight cases of CAOI that required placement of a new prosthetic joint, all were successfully treated. There were no microbiologic failures. CONCLUSIONS: Candida osteoarticular infections may be successfully treated with substantially limited durations of AFT when combined with a thorough surgical approach.