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BACKGROUND: Patients with obesity experience an increased duration of labor with an increased risk for perinatal morbidity. When compared with parturients without obesity, they also experience fewer uterine contractions after administration of misoprostol. It is unclear if the same dose of misoprostol should be used for induction of labor in patients with obesity compared to non-obese patients. Therefore, we sought to investigate if a higher dose of misoprostol for patients with obesity is more effective. OBJECTIVE: This study aimed to determine if 50 µg compared with 25 µg of vaginal misoprostol reduced the time from induction start to delivery among patients with obesity. STUDY DESIGN: We performed a double-blinded, pragmatic randomized controlled trial, between June 1, 2022, and July 17, 2023. Patients with a body mass index ≥30 kg/m2 who underwent labor induction at ≥ 36 weeks' gestation, had a singleton gestation, and a cervical dilation ≤3 cm at admission were included. Patients were excluded if they had a contraindication to vaginal delivery or misoprostol administration. Patients were randomized to 25 or 50 µg of vaginal misoprostol, stratified by parity, body mass index <40 kg/m2 or ≥40 kg/m2, and provider intent to use mechanical dilation at the onset of labor induction. Usual labor management was followed at the discretion of the provider. The primary outcome was time from induction to delivery. A priori, we estimated that 90 subjects per group (N=180) were needed for an 85% power to detect a 3-hour difference between groups with a type I error of 5%. Analysis was by intention-to-treat. A 2-sample t test was used for the primary outcome, Cohen's d was used as a measure of effect, and P values were reported. RESULTS: Of the 180 patients randomized, 88 were assigned to the 25 µg group and 92 were assigned to the 50 µg group. Of those, 96.1% of patients received the designated intervention. The baseline characteristics were similar between groups. No difference was found in the primary outcome of time to delivery (21.6 hours vs 18.6 hours; d=.28; 95% confidence interval, -0.02 to 0.57). In a planned subgroup analysis, multiparous patients delivered faster in the 50 µg group (15.2 hours vs 12.0 hours; d=.51; 95% confidence interval, 0.04-0.97). The risk for tachysystole associated with fetal heart tracing changes was rare overall (2.2%) and not significantly different between groups. No differences in maternal or neonatal adverse effects were observed. CONCLUSION: Patients with obesity who underwent cervical ripening with 50 µg of vaginal misoprostol experienced a similar time to delivery when compared with those who received 25 µg of misoprostol. However, multiparous patients had a significantly reduced time to delivery when 50 µg was used. A higher dose of misoprostol may be a promising intervention for reducing time in labor, which warrants further study.
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Índice de Massa Corporal , Trabalho de Parto Induzido , Misoprostol , Ocitócicos , Adulto , Feminino , Humanos , Gravidez , Administração Intravaginal , Relação Dose-Resposta a Droga , Método Duplo-Cego , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Obesidade , Ocitócicos/administração & dosagem , Fatores de TempoRESUMO
OBJECTIVE: Following the release of A Randomized Trial of Induction versus Expectant Management (ARRIVE) trial, the induction of labor at 39 weeks has increased in the United States. The risk of uterine rupture and optimal timing of elective induction in those patients with a prior cesarean delivery is not well-described, and they were not included in the original trial. We aimed to determine the risk of uterine rupture in those patients undergoing elective induction of labor with prior cesarean delivery. STUDY DESIGN: This was a retrospective cohort of participants with prior cesarean delivery from 1996 to 2000. Participants were included if they had two or more prior cesareans. Participants were excluded if they had a history of an unknown prior incision, a classical incision, gestational age <39 weeks, any diabetes, chronic hypertension, twin gestation, collagen or vascular disease, or HIV. Those undergoing expectant management were compared with those undergoing elective induction with no medical or obstetrical indications for delivery. Analysis was performed at three gestational age groups: 39 weeks, 40 weeks, and 41 weeks. The primary outcomes were uterine rupture, rates of successful vaginal delivery, and a composite major morbidity risk. Multivariable logistic regression was performed. RESULTS: At 39 weeks, 618 (10.3%) elective inductions were compared with 5,365 (89.7%) undergoing expectant management; uterine rupture occurred more frequently (13 patients [2.1%] vs. 49 patients [0.9%]; adjusted odds ratio [aOR], 2.5; 95% confidence interval, 1.3-4.6) with fewer successful vaginal birth after cesarean [VBAC; 66.8 vs. 75%; aOR, 0.6; 95% confidence interval, 0.5-0.7]. The risk of uterine rupture was similar between groups at 40 weeks (5 patients [0.8%] vs. 21 patients [1.2%]; p = 0.387) and 41 weeks (7 patients [1.4%] vs. 2 patients (0.8%); p = 0.448). CONCLUSION: Patients undergoing elective induction of labor with a prior cesarean scar had an increased risk of uterine rupture when compared with expectant management at 39 weeks, with fewer successful VBAC. KEY POINTS: · TOLAC elective induction at 39 weeks has an increased risk of uterine rupture.. · TOLAC elective induction at 39 weeks has a less successful chance of vaginal delivery.. · Awaiting spontaneous labor in this cohort does not increase the risk of uterine rupture..
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OBJECTIVE: Periviable premature rupture of membranes (PROM) counseling should describe maternal and neonatal outcomes associated with both immediate delivery and expectant management. Unfortunately, most published data focuses on neonatal outcomes and maternal risk estimates vary widely. We performed a meta-analysis to describe outcomes associated with expectant management compared with immediate delivery of periviable PROM. STUDY DESIGN: We performed a search on PubMed, MEDLINE, Web of Science, PROSPERO, Cochrane library, and ClinicalTrials.gov utilizing a combination of key terms. Published clinical trials and observational cohorts were included if published after 2000. Publications were selected if they included maternal and/or neonatal outcomes for both expectant management and immediate delivery. Gestational age range was limited from 14 to 25 weeks. The primary outcome was maternal sepsis. Secondary outcomes included chorioamnionitis, hemorrhage, laparotomy, and neonatal survival. Pooled risk differences (RDs) were calculated for each outcome using a random-effects model. Publication bias was assessed using funnel plots and Harbord test. RESULTS: A total of 2,550 studies were screened. After removal of duplicates and filtering by abstract, 44 manuscripts were reviewed. A total of five publications met inclusion for analysis: four retrospective and one prospective. Overall, 364 (68.0%) women underwent expectant management and 171 (32.0%) underwent immediate delivery. Maternal sepsis was significantly more frequent in the expectant group (RD, 4%; 95% confidence interval, 2-7%) as was chorioamnionitis (RD: 30%; p < 0.01) and any laparotomy (RD: 28%; p < 0.01). Neonatal survival in the expectant group was 39% compared with 0% in the immediate group (p < 0.01). CONCLUSION: Women who undergo expectant management following periviable rupture of membranes experience significantly increased risks of sepsis, chorioamnionitis, and laparotomy. Overall, 39% of neonates survive to discharge. Knowledge of these risks is critical to counseling patients with this diagnosis. KEY POINTS: · Expectant management associated with 4% increased risk of sepsis.. · Expectant management associated with 30% increased risk of chorioamnionitis.. · A total of 39% of neonates survived to discharge with expectant management..
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Corioamnionite , Ruptura Prematura de Membranas Fetais , Humanos , Gravidez , Feminino , Recém-Nascido , Corioamnionite/epidemiologia , Idade Gestacional , Conduta Expectante , Sepse/epidemiologia , Parto Obstétrico , Fatores de RiscoRESUMO
OBJECTIVE: Nationwide, obstetric clinics modified prenatal care to include telehealth visits in response to the coronavirus disease 2019 (COVID-19) pandemic, enabling the opportunity to investigate its impact on patient outcomes. We hypothesized that use of prenatal telehealth visits would increase the number of prenatal visits, decrease the frequency of urgent triage/emergency department (ED) visits, and improve perinatal outcomes. This study aimed to determine the impact of telehealth on number of obstetric prenatal visits and urgent triage/ED visits amidst the COVID-19 pandemic. STUDY DESIGN: This is a retrospective cohort of patients from a federally qualified health center in central Texas. Patients with a singleton gestation who delivered after 32 weeks were included. Comparison groups were made between those patients who delivered between May 2020 and December 2020 (presumed modified prenatal visit schedule with in-person and telehealth) and those patients delivering between June 2019 and February 2020 (the traditional care model with in-person visits only). Multivariable linear and logistic regression models were used to estimate differences in the number of prenatal visits and unscheduled triage/ED visits. RESULTS: A total of 1,654 patients were identified with 801 (48.4%) patients undergoing modified prenatal care and 853 (51.6%) patients receiving traditional care during the study period. No significant differences were seen in overall prenatal attendance or triage/ED presentations. However, when stratified by parity, multiparous patients undergoing modified prenatal care were less likely to experience an urgent triage/ED presentation (8.7 vs. 12.7%; odds ratio, 1.69; 95% confidence interval, 1.10-2.61). CONCLUSION: When compared with a traditional prenatal visitation cohort prepandemic, patients who received modified telehealth prenatal care during the COVID-19 pandemic had similar prenatal attendance and unscheduled emergency presentations. However, multiparous patients experienced a decreased rate of unscheduled emergency presentations. Supplementing prenatal care with telehealth may provide overall comparable prenatal care delivery. KEY POINTS: · Use of telehealth has the potential to improve prenatal care.. · The COVID-19 pandemic allowed for comparison to traditional prenatal care.. · Multiparous patients had a decreased frequency of ED visits.. · Similar prenatal attendance was seen between both prenatal models..
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OBJECTIVES: To assess physiologic blood pressure (BP) changes throughout pregnancy in patients with mild chronic hypertension (CHTN) who do and do not develop preeclampsia (PEC), compared to patients with normal BP. STUDY DESIGN: Retrospective cohort of singleton gestations with CHTN at a single tertiary center from 2000 to 2014 and a randomly selected cohort of patients without CHTN and normal pregnancy outcomes (NML) in the same time period with BP measurements available <12 weeks gestational age. MAIN OUTCOME MEASURES: The primary outcome was gestational age (GA) at nadir of systolic and diastolic BP. Secondary outcomes included perinatal death, umbilical cord pH, maternal and neonatal length of stay, GA at delivery, and mode of delivery. Quadratic mixed models were used to estimate SBP and DBP throughout gestation. RESULTS: Of 367 pregnancies with CHTN, 268 (73%) had CHTN without PEC and 99 (27%) had CHTN with PEC; 198 NML pregnancies were used as a comparison group. The median GA nadir for patients in the NML, CHTN without PEC, and CHTN with PEC for SBP were 20, 24, and 21, respectively. For DBP, the median GA nadir were 22, 24, and 21 for patients in the NML, CHTN without PEC, and CHTN with PEC cohorts, respectively. Adverse secondary outcomes were more frequent in patients with CHTN who developed PEC. CONCLUSIONS: BP trajectories in pregnancy are different between patients with CHTN with PEC, CHTN without PEC, and patients with normal BP. These findings may be useful in assessing patients' risks for developing preeclampsia during pregnancy.
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Pressão Sanguínea , Hipertensão , Pré-Eclâmpsia , Humanos , Gravidez , Feminino , Estudos Retrospectivos , Adulto , Pré-Eclâmpsia/fisiopatologia , Hipertensão/fisiopatologia , Idade Gestacional , Resultado da Gravidez , Estudos de Casos e Controles , Complicações Cardiovasculares na Gravidez/fisiopatologia , Índice de Gravidade de Doença , Doença CrônicaRESUMO
OBJECTIVE: To develop a predictive model for peripartum infection among high risk laboring patients in Cameroon, Africa. STUDY DESIGN: We conducted a secondary analysis of the Cameroon Antibiotic Prophylaxis Trial (NCT03248297), a multicenter 3-arm double-blind randomized controlled trial of oral azithromycin ± amoxicillin among term pregnancies with prolonged labor or rupture of membranes in Cameroon 1/2018-5/2020. Patients with chorioamnionitis prior to randomization, study drug contraindications, or planned cesarean were excluded. The outcome of interest was a composite of maternal peripartum infection (chorioamnionitis, endometritis, sepsis by World Health Organization criteria, wound infection/abscess) diagnosed up to 6 weeks postpartum. Potential predictors were compared between patients with and without the composite outcome, and evaluated at a 0.05 alpha level. Statistically significant exposures were analyzed using multivariable regression (to generate adjusted odds ratios and 95 % confidence intervals) with backwards selection to generate a parsimonious model. Receiver operating characteristic curves with associated area under the curve assessed the model's predictive ability. A nomogram based on the final best fit multivariable model was constructed. RESULTS: Of 756 patients in the parent trial, 652 were analyzed: 45 (7 %) had peripartum infection. Those with infection were more likely to be nulliparous, lower education level, higher gestational age, receive antibiotics per hospital protocols, and undergo cesarean. In our best-fit multivariable model, none/primary education (vs university), cesarean birth, and antibiotic receipt per physician discretion (vs for cesarean prophylaxis) were significantly associated with increased infection risk. This model was moderately predictive (AUC = 0.75, 95 % CI 0.67-0.82). When using this 3 factor model, for a patient with a cesarean birth, receipt of antibiotics per physician discretion, and university education, the probability of peripartum infection was 35 % (95 % CI 0.11-0.73). CONCLUSIONS: While several variables such as parity are associated with infectious morbidity within 6 weeks among high risk laboring patients in Cameroon, only education level, antibiotic indication, and cesarean birth were independently associated, and a model including these 3 factors was moderately predictive. Validation of our findings in a larger population is warranted.