Outpatient Foley Catheter for Induction of Labor in Obese Nulliparous Patients: A Secondary Analysis of OFFSITE II Randomized Controlled Trial.

OBJECTIVE: In the OFFSITE II randomized controlled trial, outpatient cervical ripening with a Foley catheter (CF) in nulliparous patients undergoing elective induction of labor (eIOL) shortened the time from admission to delivery. Given that patients with obesity have protracted labor and higher rates of failed IOL, we sought to determine if outpatient ripening with a CF may be even more beneficial for this high-risk group. STUDY DESIGN: We performed a secondary analysis of the OFFSITE II randomized controlled trial. For this analysis, all patients from the primary trial were classified by their intervention assignment (inpatient vs. outpatient) and also by their admission body mass index (BMI) class (BMI ≥ 30 and BMI < 30 kg/m2). The primary outcome was time from labor and delivery (L&D) admission to delivery. Secondary outcomes included cesarean delivery, time from admission to hospital discharge, and rates of clinically diagnosed chorioamnionitis and endometritis. RESULTS: In patients with BMI ≥ 30, the primary outcome, time from admission to delivery, (18.0 [13.5-20.9] vs. 20.4 [16.6-31.3] hours, p = 0.01), as well as total hospitalization length (3.2 [2.5-3.3] vs. 3.4 [3.1-4.3] days, p = 0.02) were shorter in the outpatient group. There were no differences in rates of chorioamnionitis or endometritis in outpatient compared with inpatient CF. Furthermore, in those with a BMI ≥ 30, the cesarean rate was significantly lower with outpatient CF (19.4% vs. 44.7%, p = 0.03); it was not statistically different in patients with BMI < 30. CONCLUSION: In this exploratory retrospective secondary analysis of the OFFSITE II randomized control trial, we found that in patients with BMI ≥ 30 undergoing eIOL, outpatient CF was associated with a lower time from L&D admission until delivery. This was also associated with a shorter time of total hospital duration and decreased the rate of cesarean, a benefit not detected in the overall analysis presented in the primary study. In nulliparas undergoing induction of labor, ripening with outpatient cervical Foley may even more significantly reduce labor duration, total hospital duration, and the rate of cesarean in patients with obesity. KEY POINTS: · Outpatient CF was associated with a lower time from L&D admission until delivery in obese nulliparas.. · Outpatient CF was associated with a shorter time of total hospital duration in obese nulliparas.. · Outpatient CF was associated with a decreased rate of cesarean birth in obese nulliparas..

Venous thromboembolism and adverse outcomes in highest thromboembolism risk patients compared with those at lower risk.

BACKGROUND: A risk-based institutional protocol for inpatient heparin-based venous thromboembolism prophylaxis in a general obstetrical population previously demonstrated a greater than 2-fold increase in wound hematomas with no change in the frequency of thromboembolism. OBJECTIVE: We sought to compare the rates of thromboembolism and bleeding outcomes in patients at the highest risk for thromboembolism (eg, those with a history of thromboembolism or thrombophilia who require anticoagulation prophylaxis or therapy throughout pregnancy) than low-risk patients. STUDY DESIGN: We performed a retrospective cohort study of all deliveries >20 weeks at a single center from 2013-2018. Patients were categorized as high-risk (received outpatient heparin-based prophylaxis or treatment) or low-risk (no outpatient anticoagulation). The primary outcome was newly diagnosed postpartum thromboembolism; the main secondary outcome was wound/perineal hematoma. The outcomes were compared between the high- and low-risk cohorts. Adjusted odds ratios (with 95% confidence intervals) were calculated with the low-risk group as reference. RESULTS: Of 24,303 total deliveries, 395 (1.7%) were high-risk and 23,905 (98.3%) were low-risk. Among the low-risk patients, 8.6% received anticoagulation prophylaxis in accordance with our risk-based inpatient thromboembolism prophylaxis protocol. High-risk patients were more likely to be older and have a higher body mass index, earlier delivery gestational age, medical comorbidities, and pregnancy complications, eg, preeclampsia. Despite outpatient antepartum anticoagulation, high-risk patients had an 11-fold increased risk of thromboembolism (adjusted odds ratio, 11.1 [4.7-26.2]) than low-risk patients. High-risk patients also had significantly more wound/perineal hematomas (adjusted odds ratio, 4.8 [2.7-8.4]), overall wound complications (adjusted odds ratio, 3.0 [2.0-4.4]), blood transfusions, intensive care unit admissions, maternal deaths, and longer maternal lengths of stay. CONCLUSION: Patients at the highest risk of obstetrical thromboembolism had an 11-fold increased risk of thromboembolism with a more moderate increase (∼5-fold) in postpartum wound and bleeding complications than low-risk patients. This more favorable risk or benefit profile supports current anticoagulation recommendations in high-risk patients.

Skin preparation type and post-cesarean infection with use of adjunctive azithromycin prophylaxis.

OBJECTIVE: To compare the frequency of postoperative surgical site infection (SSI) by type of skin preparation used for unscheduled cesarean in the setting of adjunctive azithromycin prophylaxis. METHODS: Secondary analysis of a multi-center randomized controlled trial of adjunctive azithromycin (500 mg intravenous) versus placebo in women who were ≥24 weeks gestation and undergoing unscheduled cesarean (i.e. during labor or ≥4 h after membrane rupture). Type of skin preparation used was identified based on the protocol at the hospital at the time of delivery: iodine-alcohol, chlorhexidine, chlorhexidine-alcohol, or the combination of chlorhexidine-alcohol and iodine. The primary outcome of this analysis was incidence of post-operative SSI, as defined by CDC criteria. Multivariable logistic regression was applied for adjustments. RESULTS: All 2013 women in the primary trial were included in this analysis. Women were grouped according to type of skin preparation received: iodine-alcohol (n = 193), chlorhexidine (n = 733), chlorhexidine-alcohol (n = 656), and chlorhexidine-alcohol and iodine combined sequentially (n = 431). The unadjusted rates of wound infection ranged from 2.9% to 5.7%. Using iodine-alcohol as the referent, the adjusted odds ratios for wound SSI were 0.71 (95% CI 0.30-1.66) for chlorhexidine, 0.97 (95% CI 0.41-2.28) for chlorhexidine-alcohol, and 0.88 (95% CI 0.36-2.20) for chlorhexidine-alcohol with iodine combination. CONCLUSION: In women undergoing unscheduled cesarean delivery in a trial of adjunctive azithromycin, the type of skin preparation used did not appear to be associated with the frequency of wound SSI.

Evaluation of a Risk-Stratified, Heparin-Based, Obstetric Thromboprophylaxis Protocol.

OBJECTIVE: To evaluate outcomes before and after implementation of a risk-stratified heparin-based obstetric thromboprophylaxis protocol. METHODS: We performed a retrospective cohort study of all patients who delivered at our tertiary care center from 2013 to 2018. Deliveries were categorized as preprotocol (2013-2015; no standardized heparin-based thromboprophylaxis) and postprotocol (2016-2018). Patients receiving outpatient anticoagulation for active venous thromboembolism (VTE) or high VTE risk were excluded. Coprimary effectiveness and safety outcomes were postpartum VTEs and wound hematomas, respectively, newly diagnosed after delivery and up to 6 weeks postpartum. Secondary outcomes were other wound or bleeding complications, including unplanned surgical procedures (eg, hysterectomies, wound explorations) and blood transfusions. Outcomes were compared between groups, and adjusted odds ratios (aORs) and 95% CIs were calculated using the preprotocol group as reference. RESULTS: Of 24,229 deliveries, 11,799 (49%) occurred preprotocol. Although patients were more likely to receive heparin-based prophylaxis postprotocol (15.6% vs 1.2%, P<.001), there was no difference in VTE frequency between groups (0.1% vs 0.1%, odds ratio 1.0, 95% CI 0.5-2.1). However, patients postprotocol experienced significantly more wound hematomas (0.7% vs 0.4%, aOR 2.34, 95% CI 1.54-3.57), unplanned surgical procedures (aOR 1.29, 95% CI 1.06-1.57), and blood transfusions (aOR 1.34, 95% CI 1.16-1.55). CONCLUSION: Risk-stratified heparin-based thromboprophylaxis in a general obstetric population was associated with increased wound and bleeding complications without a complementary decrease in postpartum VTE. Guidelines recommending this strategy should be reconsidered.

Neonatal Outcomes at Extreme Prematurity by Gestational Age Versus Birth Weight in a Contemporary Cohort.

OBJECTIVE: The aim of the study is to describe the rates of neonatal death and severe neonatal morbidity in a contemporary cohort, as well as to evaluate the predictive value of birth gestational age (GA) and birth weight, independently and combined, for neonatal mortality and morbidity in the same contemporary cohort. STUDY DESIGN: We performed a secondary analysis of an international, multicenter randomized controlled trial of delayed umbilical cord clamping versus umbilical cord milking in preterm infants born at 230/7 to 316/7 weeks of gestation. The current analysis was restricted to infants delivered <28 weeks. The primary outcomes of this analysis were neonatal death and a composite of severe neonatal morbidity. Incidence of outcomes was compared by weeks of GA, with planned subanalysis comparing small for gestational age (SGA) versus non-SGA neonates. Multivariable logistic regression was then used to model these outcomes based on birth GA, birth weight, or a combination of both as primary independent predictors to determine which had superior ability to predict outcomes. RESULTS: Of 474 neonates in the original trial, 180 (38%) were included in this analysis. Overall, death occurred in 27 (15%) and severe morbidity in 139 (77%) neonates. Rates of mortality and morbidity declined with increasing GA (mortality 54% at 23 vs. 9% at 27 weeks). SGA infants (n = 25) had significantly higher mortality compared with non-SGA infants across all GAs (p < 0.01). There was no difference in the predictive value for neonatal death or severe morbidity between the three prediction options (GA, birth weight, or GA and birth weight). CONCLUSION: Death and severe neonatal morbidity declined with advancing GA, with higher rates of death in SGA infants. Birth GA and birth weight were both good predictors of outcomes; however, combining the two was not more predictive, even in SGA infants. KEY POINTS: · We performed a secondary analysis of multicenter randomized clinical trials.. · The study included only extremely preterm neonates <28 weeks.. · We provide rates of neonatal morbidity in a contemporary cohort..

Association between Number of Prior Cesareans and Early Preterm Delivery in Women with Abnormal Placentation.

OBJECTIVE: Delivery timing at 34 to 36 weeks is nationally recommended for pregnancies complicated by placenta accreta spectrum (PAS). However, it has recently been suggested that those with ≥2 prior cesarean deliveries (CD) and PAS should be delivered earlier than 34 weeks because of a higher risk of unscheduled delivery and complications. We sought to evaluate whether the number of prior CD in women with PAS is associated with early preterm delivery (PTD) (<34 weeks). We also evaluated the same relationship in women with placenta previa alone (without PAS). STUDY DESIGN: This is a secondary analysis of a multicenter and observational study that included women with prior CD (maternal-fetal medicine unit cesarean registry). Women with a diagnosis of PAS (regardless of placenta previa) were included for our primary analysis, and women with known placenta previa (without a component of PAS) were independently analyzed in a second analysis. Two groups of patients from the registry were studied: patients with PAS (regardless of placenta previa) and patients with placenta previa without PAS. The exposure of interest was the number of prior CD: ≥2 CD compared with <2 CD. The primary outcome was PTD <34 weeks. Secondary outcomes included preterm labor requiring hospitalization or tocolysis, transfusion of blood products, composites of maternal and neonatal morbidities, and NICU admission. Outcomes by prior CD number groups were compared in both cohorts. Backward selection was used to identify parsimonious logistic regression models. RESULTS: There were 194 women with PAS, 97 (50%) of whom had <2 prior CD and 97 (50%) of whom had ≥2 prior CD. The rate of PTD <34 weeks in women with ≥2 prior CD compared with <2 in the setting of PAS was 23.7 versus 29.9%, p = 0.27; preterm labor requiring hospitalization was 24.7 versus 13.5%; p = 0.05. The rates of plasma transfusion were increased with ≥2 prior CD (29.9 vs. 17.5%, p = 0.04), but there were no differences in transfusion of other products or in composite maternal or neonatal morbidities. After multivariable adjustments, having ≥2 CDs was not associated with PTD <34 weeks in women with PAS (adjusted odds ratio (aOR): 0.73, 95% confidence interval [CI]: 0.39-13.8) despite an association with preterm labor requiring hospitalization (aOR: 2.69; 95% CI: 1.15-6.32). In our second analysis, there were 687 women with placenta previa, 633 (92%) with <2 prior CD, and 54 (8%) with ≥2 prior CD. The rate of PTD <34 weeks with ≥2 CD in the setting of placenta previa was not significantly increased (27.8 vs. 22.1%, aOR: 1.49; 95% CI: 0.77-2.90, p = 0.08); the maternal composite outcome (aOR: 4.85; 95% CI: 2.43-9.67) and transfusion of blood products (aOR: 6.41; 95% CI: 2.30-17.82) were noted to be higher in the group with ≥2 prior CD. CONCLUSION: Women with PAS who have had ≥2 prior CD as compared with women with <2 prior CD did not appear to have a higher risk of complications leading to delivery prior to 34 weeks. As such, considering the associated morbidity with early preterm birth, we would not recommend scheduled delivery prior to 34 weeks in this population. KEY POINTS: · We do not recommend delivery prior to 34 weeks of gestational age in PAS.. · PTD was not significantly increased in PAS with ≥2 CDs.. · PTD < 34 weeks of gestational age was not increased in placenta previa with ≥2 prior CDs..

Perinatal Outcomes in Women with a History of Recurrent Pregnancy Loss.

OBJECTIVE: This study aimed to evaluate perinatal outcomes in women with a history of recurrent pregnancy loss. STUDY DESIGN: Retrospective cohort study of singleton and nonanomalous gestations at ≥ 20 weeks who delivered at our academic institution. The exposed group was defined as women with a history of ≥ 2 consecutive spontaneous abortions (SABs) at < 12 weeks. These women were compared with women with a history of ≤ 1 SAB at < 12 weeks. The primary outcome was preterm birth (PTB) at < 37 weeks. Secondary outcomes included gestational age at delivery, gestational diabetes, small for gestational age birth weight, hypertensive diseases of pregnancy, fetal demise, cesarean delivery, and a composite of neonatal complications (5-minute Apgar score < 5, perinatal death, and NICU admission). Multivariable logistic regression was performed to adjust for confounders. RESULTS: Of 17,670 women included, 235 (1.3%) had a history of ≥ 2 consecutive SABs. Compared with women with a history of ≤ 1 SAB, women with ≥ 2 consecutive SABs were not more likely to have a PTB (19.6 vs. 14.0%, p = 0.01, adjusted odds ratios (AOR): 0.91, 95% confidence interval [CI]: 0.62-1.33). However, they were more likely to deliver at an earlier mean gestational age (37.8 ± 3.4 vs. 38.6 ± 2.9 weeks, p < 0.01) and to have gestational diabetes (12.3 vs. 6.6%, p < 0.01, AOR: 1.69, 95% CI: 1.10-2.59). Other outcomes were similar between the two groups. CONCLUSION: A history of ≥ 2 consecutive SABs was not associated with an increased incidence of PTB but may be associated with gestational diabetes in a subsequent pregnancy. KEY POINTS: · This was a retrospective cohort study.. · Women with a history of recurrent pregnancy loss (RPL) were studied.. · RPL was associated with an increase in preterm birth..

Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial.

OBJECTIVE: To assess whether outpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing elective labor induction shortens the time from admission to delivery. METHODS: We performed a randomized controlled trial of patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5. Women were randomized 1:1 to outpatient or inpatient transcervical Foley. In the outpatient group, the Foley was inserted the day before admission for scheduled induction; insertion was performed at scheduled admission in the inpatient group. The primary outcome was duration of time from admission to the labor and delivery unit to delivery. With 80% power and a two-sided α of 0.05, a sample size of 126 was estimated to detect at least a 5-hour mean difference in time from admission to delivery between groups from a baseline duration of 19±10 hours. RESULTS: From May 2018 to October 2019, 126 women were randomized, 63 in each group. Baseline characteristics were balanced between groups, except that body mass index (31±5.4 vs 34±7.5, P=.01) and group B streptococcus colonization (31% vs 54%, P=.01) were lower in the outpatient group. The time from admission to delivery was shorter in the outpatient group (17.4±7.4 vs 21.7±9.1 hours, P<.01, mean difference 4.3 hours, 95% CI 1.3-7.2). Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR] 4.7, 95% CI 1.4-15.4, P<.01), as was median modified Bishop score on admission (3 vs 1, P<.01). Cesarean delivery (24% vs 32%, RR 0.8, 95% CI 0.4-1.3, P=.32) and chorioamnionitis (22% vs 13%, RR 1.8, 95% CI 0.8-3.9, P=.16) were not significantly different between groups. CONCLUSION: In nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery. CLINCAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03472937.

Perinatal Outcomes with Longer Second Stage of Labor: A Risk Analysis Comparing Expectant Management to Operative Intervention.

OBJECTIVE: The aim of this study is to assess the impact of a prolonged second stage of labor on maternal and neonatal outcomes by comparing women who had expectant management versus operative intervention beyond specified timeframes in the second stage of labor. STUDY DESIGN: Retrospective cohort including live singletons at ≥36 weeks who reached the second stage of labor. Expectant management (second stage >3, 2, 2, and 1 hour in nulliparas with an epidural, nulliparas without an epidural, multiparas with an epidural, and multiparas without an epidural, respectively) was compared with those who had an operative delivery (vaginal or cesarean) prior to these timeframes. The primary maternal outcome was a composite of postpartum hemorrhage, chorioamnionitis, operative complications, postpartum infections, and intensive care unit admission. The primary neonatal outcome was a composite of cord blood acidemia, 5-minute Apgar's score <5, chest compressions or intubation at birth, sepsis, seizures, birth injury, death, transfer to a long-term care facility, and respiratory support for >1 day. RESULTS: Among 218 women, 115 (52.8%) had expectant management. Expectant management was associated with a significantly increased risk of the maternal composite (adjusted odds ratio [aOR]: 1.99, 95% confidence interval [CI]: 1.09-3.64) but not the neonatal composite (aOR: 1.54, 95% CI: 0.71-3.35). CONCLUSION: Expectant management of a prolonged second stage was associated with a higher rate of adverse maternal outcomes, but the rate of adverse neonatal outcomes was not significantly increased.

Impact of Azithromycin-Based Extended-Spectrum Antibiotic Prophylaxis on Noninfectious Cesarean Wound Complications.

OBJECTIVE: Adding azithromycin to standard antibiotic prophylaxis for unscheduled cesarean delivery has been shown to reduce postcesarean infections. Because wound infection with ureaplasmas may not be overtly purulent, we assessed the hypothesis that azithromycin-based extended-spectrum antibiotic prophylaxis also reduces wound complications that are identified as noninfectious. STUDY DESIGN: This is a secondary analysis of the C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) randomized controlled trial, which enrolled women with singleton pregnancies ≥24 weeks who were undergoing nonelective cesarean. Women were randomized to adjunctive azithromycin or identical placebo up to 1 hour preincision. All wound complications occurring within 6 weeks were adjudicated into infection and noninfectious wound complications (seroma, hematoma, local cellulitis, and other noninfectious wound breakdown). The primary outcome for this analysis is the composite of noninfectious wound complications. RESULTS: At a total of 14 sites, 2,013 women were randomized to adjunctive azithromycin (n = 1,019) or placebo (n = 994). Groups were similar at baseline. Although there was a lower rate of noninfectious wound complications in the azithromycin group compared with placebo (2.9 vs. 3.8%), this was not statistically significant (p = 0.22). CONCLUSION: While adding azithromycin to usual antibiotic prophylaxis for nonelective cesarean delivery does reduce the risk of postcesarean infections, it did not significantly reduce the risk of postcesarean noninfectious wound complications.