Neonatal outcomes in term and preterm infants following adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery.

OBJECTIVE: It is currently unknown whether adjunctive azithromycin prophylaxis at the time of non-elective cesarean has differential effects on neonatal outcomes in the context of prematurity. The objective of this study was to compare whether neonatal outcomes differ in term and preterm infants exposed to adjunctive azithromycin prophylaxis before non-elective cesarean delivery. STUDY DESIGN: A planned secondary analysis of a multi-center randomized controlled trial that enrolled women with singleton pregnancies ≥24 weeks gestation undergoing non-elective cesarean delivery (during labor or ≥4 h after membrane rupture). Women received standard antibiotic prophylaxis and were randomized to either adjunctive azithromycin (500 mg) or placebo. The primary composite outcome was neonatal death, suspected or confirmed neonatal sepsis, and serious neonatal morbidities (NEC, PVL, IVH, BPD). Secondary outcomes included NICU admission, neonatal readmission, culture positive infections and prevalence of resistant organisms. Odds ratios (OR) for the effect of azithromycin versus placebo were compared between gestational age strata (preterm [less than 37 weeks] versus term [37 weeks or greater]). Tests of interaction examined homogeneity of treatment effect with gestational age. RESULTS: The analysis includes 2,013 infants, 226 preterm (11.2%) and 1,787 term. Mean gestational ages were 34 and 39.5 weeks, respectively. Within term and preterm strata, maternal and delivery characteristics were similar between the azithromycin and placebo groups. There was no difference in the odds of composite neonatal outcome between those exposed to azithromycin versus placebo in preterm neonates (OR 0.82, 95% CI 0.48-1.41) and in term neonates (OR 1.06, 95% CI 0.77-1.46), with no difference between gestational age strata (p = 0.42). Analysis of secondary outcomes also revealed no differences in treatment effects within or between gestational age strata. CONCLUSION: Exposure to adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery does not increase neonatal morbidity or mortality in term or preterm infants. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov, NCT01235546.

Postpartum Outcomes in Patients Receiving Venous Thromboembolism Prophylaxis during Antepartum Admission.

OBJECTIVE: We evaluated if venous thromboembolism (VTE) prophylaxis in the inpatient antepartum period was associated with wound hematomas, VTE occurrence, and other adverse outcomes. STUDY DESIGN: This study is a secondary analysis of a retrospective cohort of patients who delivered at University of Alabama at Birmingham (UAB). Patients receiving outpatient anticoagulation (AC) were excluded. We grouped patients into those who received inpatient antepartum prophylactic AC and those who did not. The primary outcome was wound hematomas from delivery to 6 weeks postpartum (PP). Secondary outcomes included VTE occurrence and select adverse outcomes, including other wound complications, unplanned procedures, mode of anesthesia, and intensive care unit (ICU) admission. Analyses were performed with no AC group as the reference. A sensitivity analysis excluding those who received inpatient PP AC was performed. RESULTS: Of 1,035 included patients, only 169 patients received inpatient prophylactic AC. They were older, had higher body mass indices, and more comorbidities. Patients receiving inpatient antepartum AC had higher wound hematomas (adjusted odds ratio [aOR] 23.81; 95% confidence interval [CI] 7.04-80.47). They had similar risk for developing VTE as the control group (aOR 2.68; 95% CI 0.19-37.49) but were more likely to have wound complications (aOR 2.36; 95% CI 1.24-4.47), maternal deaths (p < 0.05), and require PP ICU admission (aOR 13.38; 95% CI 4.79-37.35). When excluding those receiving any PP AC, there was no difference in bleeding complications between the two groups and VTE rates remained unchanged. Rates of maternal deaths and PP ICU admissions remained higher in those who received inpatient antepartum AC prophylaxis. CONCLUSION: In this small cohort study, increased wound hematomas were found in those who received inpatient antepartum AC prophylaxis with no difference in VTE occurrence. While adverse events were increased in the inpatient AC group, this was mostly associated with PP AC prophylaxis. Larger studies should be conducted to describe the true benefits and risks of antepartum AC prophylaxis and determine efficacy of this widely used practice. KEY POINTS: · Peripartum chemoprophylaxis is associated with increased wound hematomas.. · VTE is rare, despite its association with significant peripartum morbidity/mortality.. · Large studies are needed to guide practices that optimize the risk/benefit ratio of chemoprophylaxis..

Physiologic blood pressure patterns in pregnancies with mild chronic hypertension.

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.

Sexual risk characteristics, social vulnerability, and anal cancer screening uptake among men living with HIV in the deep south.

ABSTRACTWithout standard guidelines, there is a critical need to examine anal cancer screening uptake in the South which has the highest HIV incidence in the U.S. We identified factors associated with screening among men living with HIV (MLHIV) at a large academic HIV outpatient clinic in Alabama. Relationships between sociodemographic, clinical, sexual risk characteristics and screening were examined using T-tests, Fisher's exact, Chi-square, and logistic regression analyses. Unadjusted and adjusted odds ratios (AOR) were computed to estimate the odds of screening. Among 1,114 men, 52% had received annual anal cytology (pap) screening. Men who were screened were more likely to have multiple sexual partners compared to men who were not screened (22.8% vs. 14.8%, p = 0.002). Among men with one partner, the youngest were almost five times more likely to be screened compared to middle-aged men (AOR = 4.93, 95% CI: 2.34-10.39). Heterosexual men had lower odds and men who reported unprotected anal sex had higher odds of screening. Our findings suggest a racial disparity, with older black MLHIV being the least likely to be screened. In the South, MLHIV who are older, black, heterosexual, or live in high social vulnerability counties may be less likely to receive annual anal cancer screening.

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes.

OBJECTIVE: Continuous glucose monitoring (CGM) improves maternal glycemic control and neonatal outcomes in type 1 diabetes pregnancies compared with self-monitoring of blood glucose. However, CGM targets for pregnancy are based on expert opinion. We aimed to evaluate the association between CGM metrics and perinatal outcomes and identify evidence-based targets to reduce morbidity. RESEARCH DESIGN AND METHODS: This was a retrospective cohort study of pregnant patients with type 1 or 2 diabetes who used real-time CGM and delivered at a U.S. tertiary center (2018-2021). Multiple gestations, fetal anomalies, and early pregnancy loss were excluded. Exposures included time in range (TIR; 65-140 mg/dL), time above range (TAR), time below range (TBR), glucose variability, average glucose, and glucose management indicator. The primary outcome was a composite of fetal or neonatal mortality, large or small for gestational age at birth, neonatal intensive care unit admission, hypoglycemia, shoulder dystocia or birth trauma, and hyperbilirubinemia. Logistic regression estimated the association between CGM metrics and outcomes, and optimal TIR was calculated. RESULTS: Of 117 patients, 16 (13.7%) used CGM before pregnancy and 68 (58.1%) had type 1 diabetes. Overall, 98 patients (83.8%) developed the composite neonatal outcome. All CGM metrics, except TBR, were associated with neonatal morbidity. For each 5 percentage-point increase in TIR, there was 28% reduced odds of neonatal morbidity (odds ratio 0.72, 95% CI 0.58-0.89). The statistically optimal TIR was 66-71%. CONCLUSIONS: Nearly all CGM metrics were associated with adverse neonatal morbidity and mortality and may aid management of preexisting diabetes in pregnancy. Our findings support the American Diabetes Association recommendation of 70% TIR.

Outcomes in low-risk patients before and after an institutional policy offering 39-week elective induction of labor.

OBJECTIVE: Elective induction of labor versus expectant management at 39 weeks gestation in low-risk nulliparous patients was shown in the ARRIVE randomized trial of over 6000 patients to decrease risks of cesarean delivery without significant change in the composite perinatal outcome. We aimed to pragmatically analyze the effect of offering elective induction of labor (eIOL) to all low-risk patients. METHODS: Retrospective cohort study of low-risk nulliparous and multiparous patients delivering live, non-anomalous singletons at a single center at greater than or equal to 39 0/7 weeks gestational age. Those with prior or planned cesarean delivery, ruptured membranes, medical comorbidities, or contraindications to vaginal delivery were excluded. Patients were categorized as before (pre-eIOL; 1/2012-3/2014) or after (post-eIOL; 3/2019-12/2021) an institution-wide policy offering eIOL at 39 0/7 weeks. Births occurring April 2014 to December 2018 were allocated to a separate cohort (during-eIOL) given increased exposure to eIOL as our center recruited participants for the ARRIVE trial. The primary outcome was cesarean birth. Secondary outcomes included select maternal (e.g. chorioamnionitis, operative delivery, postpartum hemorrhage) and neonatal morbidities (e.g. birthweight, small- and large-for gestational age, hypoglycemia). Characteristics and outcomes were compared between the pre and during-eIOL, and pre and post-eIOL groups; adjusted OR (95% CI) were calculated using multivariable regression. Subgroup analysis by parity was planned. RESULTS: Of 10,758 patients analyzed, 2521 (23.4%) were pre-eIOL, 5410 (50.3%) during-eIOL, and 2827 (26.3%) post-eIOL. Groups differed with respect to labor type, age, race/ethnicity, marital and payor status, and gestational age at care entry. Post-eIOL was associated with lower odds of cesarean compared to pre-eIOL (aOR 0.83 [95% CI 0.72-0.96]), which was even lower among those specifically undergoing labor induction (aOR 0.58 [0.48-0.70]. During-eIOL was also associated with lower odds of cesarean compared to pre-eIOL (aOR 0.79 [0.69-0.90]). Both during and post-eIOL groups were associated with higher odds of chorioamnionitis, operative delivery, and hemorrhage compared to pre-eIOL. However, only among post-eIOL were there fewer neonates weighing ≥4000 g, large-for-gestational age infants, and neonatal hypoglycemia compared to pre-IOL. CONCLUSION: An institutional policy offering eIOL at 39 0/7 to low-risk patients was associated with a lower cesarean birth rate, lower birthweights and lower neonatal hypoglycemia, and an increased risk of chorioamnionitis and hemorrhage.

Predicting peripartum infection in laboring patients at high risk in Cameroon, Africa.

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.

Maternal and Neonatal Outcomes at Periviable Gestation throughout Delivery Admission.

OBJECTIVE: The threshold of viability, as well as cutoffs for delivery interventions and neonatal resuscitation, vary by hospital and involve complex counseling. With improvements in neonatal resuscitation and intensive care, the threshold of viability has been decreasing. Decisions regarding delivery planning and neonatal resuscitation efforts should be based on the best available evidence. Our objective was to characterize survival rates and neonatal outcomes following periviable birth at different milestones beginning with prenatal admission through 1 year of life in a contemporary cohort. STUDY DESIGN: We performed a retrospective cohort study of all inborn infants without major congenital anomalies who delivered at the University of Alabama at Birmingham from 2013 to 2019 at gestational ages 22+0/7 to 25+6/7. Our primary outcome was to compared survival milestones throughout the pre- and postdelivery periods and neonatal complications in surviving newborns through 1 year of life at each gestational age. RESULTS: The survival rate to 1 year of life was 49% (48-56%, 95% confidence interval [CI]) for the entire cohort and varied according to gestational age at delivery (22 weeks 15% [10-23%, 95% CI], 23 weeks 48% [43-58%, 95% CI], 24 weeks 57% [52-67%, 95% CI], 25 weeks 71% [67-82%, 95% CI]). Overall for the entire cohort, the rate of lung disease requiring respiratory support at discharge was 51%, intraventricular hemorrhage was 42%, retinopathy of prematurity was 74%, pulmonary hypertension was 30%, and concerns for cerebral palsy at 1 year of life was 25%. All outcomes improved with advancing gestational age at delivery. Of infants who delivered during the 22nd week of gestation, 50% received antenatal corticosteroids. Infants exposed to antenatal corticosteroids had more interventions, less pulmonary hypertension, and improved survival to 1 year of life. CONCLUSION: Knowledge of maternal complications, longitudinal survival rates, and neonatal outcomes of periviable deliveries according to gestational age throughout the admission enhances obstetric and perinatal counseling after hospital admission. KEY POINTS: · Periviable birth outcomes at different delivery milestones is important for counseling.. · Providing contemporary outcomes for periviable deliveries is critical for accurate counseling.. · Administration of antenatal corticosteroids at 22 weeks' gestation appears beneficial overall..

Contribution of Health Care Practitioner and Maternity Services Factors to Racial Disparities in Alabama: A Qualitative Study.

OBJECTIVE: Black patients are three times more likely to die of pregnancy-related causes than White patients in the United States, and Alabama has the third worst maternal mortality rate in the nation. We sought to identify health care practitioner and maternity service factors contributing to disparities in Alabama, as well as potential strategies to address these contributors. METHODS: We conducted key informant interviews with obstetricians, nurses, doulas, lactation counselors, health system administrators, and representatives of professional organizations who deliver maternity care to racially and ethnically diverse patients in Alabama. The interview guide was developed using Howell's conceptual framework on racial and ethnic disparities in severe maternal morbidity and mortality. Adopting a thematic analysis approach, we coded and analyzed transcripts using NVivo 12 software. Open coding and selective coding were conducted to identify themes related to health care practitioner- and maternity services-level determinants. RESULTS: Overall, 20 health care practitioners or administrators were interviewed. Primary themes related to health care practitioners included implicit bias and explicit racism, lack of communication and lack of positive patient-health care practitioner relationships, lack of cultural sensitivity, and variation in clinical knowledge and experience. Primary themes related to maternity services included lack of accessibility, inadequate quality and content of care, lack of continuity of care, discriminatory facility policies, and workforce shortages and lack of diversity. Strategies suggested by participants to address these factors included bias trainings for health care practitioners, improvements in racial and interdisciplinary diversity in the maternity workforce, and evidence-based interventions such as group prenatal care, disparities dashboards, simulation trainings, early warning signs criteria, and coordinated care. CONCLUSION: We gained diverse perspectives from health care practitioners and administrators on how maternity health care practitioner and maternity health services factors contribute to inequities in maternal health in Alabama. Strategies to address these contributing factors were multifaceted.

Community and Systems Contributors and Strategies to Reduce Racial Inequities in Maternal Health in the Deep South: Provider Perspectives.

Purpose: Black pregnant individuals in Alabama are disproportionately affected by severe maternal morbidity and mortality (SMM). To understand why racial disparities in maternal health outcomes persist and identify potential strategies to reduce these inequities, we sought perspectives from obstetric health care providers, health administrators, and members of local organizations who provide pregnancy, delivery, and postpartum care services in Alabama. Methods: We conducted qualitative in-depth interviews with stakeholders (n=20), purposively recruited from community-based organizations, clinical settings, government organizations, and academic institutions. Interview guides were based on Howell's conceptual model of pathways to racial disparities in maternal mortality. Data were coded using a modified framework theory approach and analyzed thematically. Results: Racism, unjust laws and policies, and poverty/lack of infrastructure in communities emerged as major themes contributing to racial disparities in maternal health at the community and systems levels. Inadequate health insurance coverage was described as a strong driver of the disparities. Service providers suggested strategies for Alabama should be community focused, evidence based, and culturally sensitive. These should include Medicaid expansion, expanded parental leave, and removal of laws restricting choice. Community- and systems-level interventions should include community infrastructure improvements, choice in maternity services, and provision of digital communication options. Conclusions: Providers shared perspectives on community and structural areas of intervention to reduce racial inequities in SMM. These results can inform discussions with health system and community partners about Alabama and other Deep South initiatives to improve maternal health outcomes in black communities.

Occipital Nerve Block Compared With Acetaminophen and Caffeine for Headache Treatment in Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of occipital nerve block compared with standard care , defined as acetaminophen with caffeine, for treatment of acute headache in pregnancy. METHODS: We conducted a single-center, unblinded, parallel, randomized controlled trial of pregnant patients with headache and pain score higher than 3 on the visual rating scale. Patients with secondary headache, preeclampsia, or allergy or contraindication to study medications were excluded. Participants were randomized to occipital nerve block or standard care (oral 650 mg acetaminophen and 200 mg caffeine). Crossover treatment was given at 2 hours and second-line treatment at 4 hours to those with worsening visual rating scale score or visual rating scale score higher than 3. The primary outcome was headache improvement to a visual rating scale score of 3 or lower within 2 hours of initial therapy. Secondary outcomes included serial visual rating scale scores, receipt of crossover or second-line therapy, patient satisfaction, and perinatal outcomes. Outcomes were assessed in an intention-to-treat analysis. We estimated that a sample of 62 would provide 80% power to detect a difference from 85% to 50% between groups. RESULTS: From February 2020 to May 2022, 62 participants were randomized to occipital nerve block (n=31) or standard care (n=31). Groups were similar except payer status. The primary outcome, headache improvement to visual rating scale score of 3 or lower, was not significantly different between groups (64.5% vs 51.6%, P =.30). The occipital nerve block group experienced lower median [interquartile range] visual rating scale scores at 1 hour (2 [0-5] vs 6 [2-7], P =.014), and more patients in the occipital nerve block group had visual rating scale scores of 3 or lower at 1 hour. Among patients receiving crossover treatment at 2 hours, the standard care group had a significantly lower visual rating scale score 1 hour after crossover to occipital nerve block than the occipital nerve block group receiving crossover to standard care ( P =.028). There were no significant differences in second-line treatment, refractory headache, satisfaction, or complications. Patients receiving occipital nerve block delivered earlier (36.6 weeks vs 37.8 weeks), but preterm birth did not differ between groups. CONCLUSION: Occipital nerve block is an effective and quick-acting treatment option for acute headache in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT03951649.

Perinatal Outcomes Associated With Management of Stage 1 Hypertension.

OBJECTIVE: To evaluate the association between maternal blood pressure (BP) below 130/80 mm Hg compared with 130-139/80-89 mm Hg and pregnancy outcomes. METHODS: We conducted a planned secondary analysis of CHAP (Chronic Hypertension and Pregnancy), an open label, multicenter, randomized controlled trial. Participants with mean BP below 140/90 mm Hg were grouped as below 130/80 mm Hg compared with 130-139/80-89 mm Hg by averaging postrandomization clinic BP throughout pregnancy. The primary composite outcome was preeclampsia with severe features, indicated preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The secondary outcome was small for gestational age (SGA). RESULTS: Of 2,408 patients in CHAP, 2,096 met study criteria; 1,328 had mean BP 130-139/80-89 mm Hg and 768 had mean BP below 130/80 mm Hg. Participants with mean BP below 130/80 mm Hg were more likely to be older, on antihypertensive medication, in the active treatment arm, and to have lower BP at enrollment. Mean clinic BP below 130/80 mm Hg was associated with lower frequency of the primary outcome (16.0% vs 35.8%, adjusted relative risk 0.45; 95% CI 0.38-0.54) as well as lower risk of severe preeclampsia and indicated birth before 35 weeks of gestation. There was no association with SGA. CONCLUSION: In pregnant patients with mild chronic hypertension, mean BP below 130/80 mm Hg was associated with improved pregnancy outcomes without increased risk of SGA. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02299414.

Breastfeeding initiation and duration among people with mild chronic hypertension: a secondary analysis of the Chronic Hypertension and Pregnancy trial.

BACKGROUND: Increased duration of breastfeeding improves maternal cardiovascular health and may be especially beneficial in high-risk populations, such as those with chronic hypertension. Others have shown that individuals with hypertension are less likely to breastfeed, and there has been limited research aimed at supporting breastfeeding goals in this population. The impact of perinatal blood pressure control on breastfeeding outcomes among people with chronic hypertension is unknown. OBJECTIVE: This study aimed to evaluate whether breastfeeding initiation and short-term duration assessed at the postpartum clinic visit differed according to perinatal blood pressure treatment strategy (targeting blood pressure <140/90 mm Hg vs reserving antihypertensive treatment for blood pressure ≥160/105 mm Hg). STUDY DESIGN: We performed a secondary analysis of the Chronic Hypertension and Pregnancy trial. This was an open-label, multicenter, randomized trial where pregnant participants with mild chronic hypertension were randomized to receive antihypertensive medications with goal blood pressure <140/90 mm Hg (active treatment) or deferred treatment until blood pressure ≥160/105 mm Hg (control). The primary outcome was initiation and duration of breastfeeding, assessed at the postpartum clinic visit. We performed bivariate analyses and log-binomial and cumulative logit regression models, adjusting models for variables that were unbalanced in bivariate analyses. We performed additional analyses to explore the relationship between breastfeeding duration and blood pressure measurements at the postpartum visit. RESULTS: Of the 2408 participants from the Chronic Hypertension and Pregnancy trial, 1444 (60%) attended the postpartum study visit and provided breastfeeding information. Participants in the active treatment group had different body mass index class distribution and earlier gestational age at enrollment, and (by design) were more often discharged on antihypertensives. Breastfeeding outcomes did not differ significantly by treatment group. In the active and control treatment groups, 563 (77.5%) and 561 (78.1%) initiated breastfeeding, and mean durations of breastfeeding were 6.5±2.3 and 6.3±2.1 weeks, respectively. The probability of ever breastfeeding (adjusted relative risk, 0.99; 95% confidence interval, 0.93-1.05), current breastfeeding at postpartum visit (adjusted relative risk, 1.01; 95% confidence interval, 0.94-1.10), and weeks of breastfeeding (adjusted odds ratio, 0.87; 95% confidence interval, 0.68-1.12) did not differ by treatment group. Increased duration (≥2 vs <2 weeks) of breastfeeding was associated with slightly lower blood pressure measurements at the postpartum visit, but these differences were not significant in adjusted models. CONCLUSION: In a secondary analysis of the cohort of Chronic Hypertension and Pregnancy trial participants who attended the postpartum study visit and provided breastfeeding information (60% of original trial participants), breastfeeding outcomes did not differ significantly by treatment group. This suggests that maintaining goal blood pressure <140/90 mm Hg throughout the perinatal period is associated with neither harm nor benefit for short-term breastfeeding goals. Further study is needed to understand long-term breastfeeding outcomes among individuals with chronic hypertension and how to support this population in achieving their breastfeeding goals.

Predicting Spontaneous Labor beyond 39 Weeks among Low-Risk Expectantly Managed Pregnant Patients.

OBJECTIVES: The aim of the study was to identify the characteristics associated with spontaneous labor onset in pregnant patients undergoing expectant management at greater than 39 weeks' gestation and delineate perinatal outcomes associated with spontaneous labor compared with labor induction. STUDY DESIGN: This was a retrospective cohort study of singleton pregnancies at ≥390/7 weeks' gestation delivered at a single center in 2013. The exclusion criteria were elective induction, cesarean delivery or presence of a medical indication for delivery at 39 weeks, more than one prior cesarean delivery, and fetal anomaly or demise. We evaluated prenatally available maternal characteristics as potential predictors of the primary outcome-spontaneous labor onset. Multivariable logistic regression was used to generate two parsimonious models: one with and one without third trimester cervical dilation. We also performed sensitivity analysis by parity and timing of cervical examination, and compared the mode of delivery and other secondary outcomes between patients who went into spontaneous labor and those who did not. RESULTS: Of 707 eligible patients, 536 (75.8%) attained spontaneous labor and 171 (24.2%) did not. In the first model, maternal body mass index (BMI), parity, and substance use were identified as the most predictive factors. Overall, the model did not predict spontaneous labor (area under the curve [AUC]: 0.65; 95% confidence interval [CI]: 0.61-0.70) with high accuracy. The addition of third trimester cervical dilation in the second model did not significantly improve labor prediction (AUC: 0.66; 95% CI: 0.61-0.70; p = 0.76). These results did not differ by timing of cervical examination or parity. Patients admitted in spontaneous labor had lower odds of cesarean delivery (odds ratio [OR]: 0.33; 95% CI: 0.21-0.53) and neonatal intensive care unit (NICU) admission (OR: 0.38; 95% CI: 0.15-0.94). Other perinatal outcomes were similar between the groups. CONCLUSION: Maternal characteristics did not predict spontaneous labor onset at ≥39 weeks' gestation with high accuracy. Patients should be counseled on the challenges of labor prediction regardless of parity and cervical examination, outcomes if spontaneous labor does not occur, and benefits of labor induction. KEY POINTS: · Majority of patients will attain spontaneous labor at ≥39 weeks.. · Maternal characteristics do not predict labor at ≥39 weeks.. · Spontaneous labor has associated lower perinatal risks.. · A shared decision model should be utilized in counseling patients who may choose expectant management..

Contemporary Trends in Cesarean Delivery Rates and Indications.

OBJECTIVE: This study aimed to describe cesarean delivery rates and indications at a single center in order to assess the impact of the guidelines published by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on trends in labor management. STUDY DESIGN: This is a retrospective cohort study of patients ≥23 weeks' gestation delivering at a single tertiary care referral center from 2013 to 2018. Demographic characteristics, mode of delivery, and main indication for cesarean delivery were ascertained by individual chart review. Cesarean delivery indications (mutually exclusive) were the following: repeat cesarean delivery, nonreassuring fetal status, malpresentation, maternal indications (e.g., placenta previa or genital herpes simplex virus), failed labor (any stage labor arrest), or other (i.e., fetal anomaly and elective). Polynomial (cubic) regression models were used to model rates of cesarean delivery and indications over time. Subgroup analyses further examined trends in nulliparous women. RESULTS: Of the 24,637 patients delivered during the study period, 24,050 were included in the analysis; 7,835 (32.6%) had a cesarean delivery. The rates of overall cesarean delivery were significantly different over time (p < 0.001), declining to a minimum of 30.9% in 2014 and peaking at 34.6% in 2018. With regard to the overall cesarean delivery indications, there were no significant differences over time. When limited to nulliparous patients, the rates of cesarean delivery were also noted to be significantly different over time (p = 0.02) nadiring at 30% in 2015 from 35.4% in 2013 and then rising up to 33.9% in 2018. As for nulliparous patients, there was no significant difference in primary cesarean delivery indications over time except for nonreassuring fetal status (p = 0.049). CONCLUSION: Despite changes in labor management definitions and guidelines encouraging vaginal birth, the rates of overall cesarean delivery did not decrease over time. The indications for delivery, particularly failed labor, repeat cesarean delivery, and malpresentation have not significantly changed over time. KEY POINTS: · The rates of overall cesarean deliveries did not decrease despite the 2014 published recommendations for the reduction in cesarean deliveries.. · There were no significant differences in the indications of cesarean deliveries among nulliparous or multiparous women.. · Despite the adoption of strategies to reduce the overall and primary cesarean delivery rates, these trends remain unchanged.. · Indications for delivery, particularly failed labor, repeat cesarean delivery, and malpresentation have also not significantly changed over time.. · Additional strategies to encourage and increase vaginal delivery rates must be adopted..

Five-year surgical outcomes of transvaginal apical approaches in women with advanced pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: In women with advanced prolapse, differences in vaginal apex anchoring sites may impact surgical outcomes over time. The primary aim was to compare 5-year surgical outcomes of uterosacral ligament suspension (ULS) versus sacrospinous ligament fixation (SSLF) in women with advanced (stage III-IV) prolapse. METHODS: A secondary analysis was conducted in a subset of women with advanced prolapse from a multicenter randomized trial comparing ULS versus SSLF and its extended follow-up, using publicly accessible de-identified datasets. The primary outcome was time to failure, defined as any one of (1) apical descent > 1/3 into the vaginal canal or anterior/posterior compartment beyond the hymen, (2) bothersome vaginal bulge symptoms, or (3) re-treatment. Secondary outcomes include symptom severity measured by the Pelvic Organ Prolapse Distress Inventory (POPDI) and adverse events. RESULTS: Of 285 women, 90/147 (61.2%) in ULS and 88/138 (63.8%) in SSLF had advanced prolapse. Baseline characteristics did not differ between groups except for median-vaginal deliveries (3.0 [2.0, 5.0] versus 3.0 [2.0, 4.0], p < 0.01). The median time to failure was 1.7 years ULS versus 2.0 years SSLF (p = 0.42). Surgical failure increased over time in both groups with no intergroup difference; by year 5, the estimated failure rate was 67.7% ULS versus 71.5% SSLF (adjusted difference -3.8; 95%CI [-21.9, 14.2]). No differences were noted in individual failure components (p > 0.05). POPDI scores improved over 5 years without intergroup difference (ULS -68.0 ± 61.1 versus SSLF -69.9 ± 60.3, adjusted difference -0.1 [-20.0, 19.9]). No difference in adverse events were observed (p > 0.05). CONCLUSION: In women with advanced prolapse, surgical failure, symptom severity, and adverse events did not differ between ULS and SSLF over 5 years.

Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial.

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

Adjunctive Azithromycin Prophylaxis for Prelabor Cesarean Birth.

OBJECTIVE: To evaluate maternal postoperative infections before and after addition of adjunctive azithromycin to standard antibiotic prophylaxis for prelabor cesarean births. METHODS: We conducted a retrospective cohort study of patients with singleton gestations at more than 23 weeks of gestation who underwent prelabor cesarean birth at a single tertiary care center. Deliveries were categorized as those before implementation of 500 mg intravenous azithromycin in addition to standard preoperative cephalosporin antibiotic prophylaxis (pre-AZI group; January 2013-September 2015) and those after implementation of adjunctive azithromycin (post-AZI group; January 2016-December 2018). Cesarean births from October to December 2015 were excluded as a washout period. The primary outcome was a composite of postcesarean infections (endometritis, superficial or deep wound infections, intra-abdominal abscess, urinary tract infections). Secondary outcomes included composite components, other wound or postoperative complications, and select neonatal morbidities. Outcomes were compared between groups, and adjusted odds ratios (aORs) and 95% CIs were calculated using multivariable analysis. Propensity score matching was performed to assess the robustness our analysis. RESULTS: Of 2,867 delivering patients included for analysis, 1,391 (48.5%) were in the pre-AZI group and 1,476 (51.5%) were in the post-AZI group. Patients in the post-AZI group were older and were more likely to have private insurance, use aspirin, and receive predelivery antibiotics within 2 weeks. There were significantly lower odds of composite infection after azithromycin implementation (3.3% vs 4.8%, aOR 0.60, 95% CI 0.40-0.89), driven by a reduction in wound infection odds (2.4% vs 3.5%, aOR 0.61, 95% CI 0.39-0.98). There were lower odds of other postpartum complications, including wound seroma (0.5% vs 0.9%, aOR 0.34, 95% CI 0.13-0.90) and dehiscence (0.5% vs 1.2%, aOR 0.32, 95% CI 0.13-0.79). There were no differences in select neonatal morbidities between groups. Of 1,138 matching sets in the propensity analysis, the primary outcome remained significantly lower in the post-AZI group (aOR 0.64, 95% CI 0.41-0.99). CONCLUSION: Adopting adjunctive azithromycin for prelabor cesarean deliveries was associated with lower odds of postpartum infection.

Defining a Strategy for Laboratory Evaluation with Expectant Management of Preeclampsia.

OBJECTIVE: The objective of this study was to compare the frequency and timing of laboratory abnormalities and evaluate optimal laboratory testing strategies in women with preeclampsia (PE) undergoing expectant management. STUDY DESIGN: Retrospective cohort study of women with inpatient expectant management of PE at ≥23 weeks at a tertiary center from 2015 to 2018 was conducted. Women ineligible for expectant management or with less than two laboratory sets (platelets, aspartate aminotransferase, and serum creatinine) before the decision to deliver were excluded. Women were categorized as per the American College of Obstetricians and Gynecologists' definitions by initial diagnosis: PE without severe features, superimposed preeclampsia (SiPE) without severe features, and their forms with severe features. The frequency and timing of laboratory abnormalities were compared across the four PE categories. Kaplan-Meier curves modeled time to a laboratory abnormality (event) with censoring for delivery and were compared using log-rank tests. Logistic regression analysis modeled the development of a laboratory abnormality as a function of testing time intervals (days) for each PE type. Receiver operating characteristic curves and areas under the curve (AUC) were calculated; optimal cut points were determined using the Liu method. RESULTS: Among 636 women who met inclusion criteria, laboratory abnormalities were uncommon (6.3%). The median time to a laboratory abnormality among all women was ≤10 days, time being shortest in women with PE with severe features. Time to laboratory abnormality development did not differ significantly between the four PE groups (p = 0.36). Laboratory assessment intervals were most predictive for PE and SiPE with severe features (AUC = 0.87, AUC = 0.72). Optimal cutoffs were every 4 days for PE without severe features, 2 days for PE with severe features, 8 days for SiPE without severe features, and 3 days for SiPE with severe features. CONCLUSION: Most laboratory abnormalities in PE occur earlier and more frequently in those with severe features. Individual phenotypes should undergo serial evaluation based on this risk stratification. KEY POINTS: · Most laboratory abnormalities occur within 10 days of diagnosis.. · Laboratory abnormalities occur more often with severe features.. · Laboratory testing should occur according to disease severity..

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..