Baha M. Sibai

OBJECTIVE: We performed a systematic review to evaluate the clinical presentation and maternal and fetal outcomes in pregnancies with early-onset HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome. DATA SOURCES: PubMed, Ovid MEDLINE, Scopus, CINAHL, Cochrane Library, and ClinicalTrials.gov were queried from inception through January 1, 2023 with the following terms: "HELLP syndrome," "HELLP," "hemolysis, elevated liver enzymes, low platelets," "hemolysis, elevated liver enzymes, low platelets syndrome," "pre-viable," "peri-viable," "previable," "periviable," "first trimester," "second trimester," "before 23 weeks," "<23 weeks," "<23 week gestation," and "before 23 weeks gestation...

FUNDING SOURCE: Supported in part by a research grant from Investigator-Initiated Studies program of Organon. The opinions expressed in this paper are those of the authors and do not necessarily represent Organon. CLINICAL TRIAL REGISTRAION: ClinicalTrials.gov, NCT04291040.

BACKGROUND: Among guidelines on gestational diabetes mellitus, there is an incongruity about the threshold of maternal hyperglycemia to diagnose gestational diabetes mellitus. OBJECTIVE: This study aimed to ascertain the association between continuous glucose monitoring metrics and adverse outcomes among individuals undergoing gestational diabetes mellitus screening. STUDY DESIGN: This was a prospective study (from June 2020 to January 2022) of individuals who underwent 2-step gestational diabetes mellitus screening at ≤30 weeks of gestation...

OBJECTIVE:  Continuous glucose monitoring (CGM) has become available for women with type 2 diabetes mellitus (T2DM) or gestational diabetes mellitus (GDM) during pregnancy. The recommended time in range (TIR, blood glucose 70-140 mg/dL) and its correlation with adverse pregnancy outcomes in this group is unknown. Our aim was to compare maternal and neonatal outcomes in pregnant people with T2DM or GDM with average CGM TIR values >70 versus ≤ 70%. STUDY DESIGN:  We conducted a retrospective cohort study of all individuals using CGM during pregnancy from January 2017 to June 2022...

OBJECTIVE:  The aim of this study was to evaluate whether being small for gestational age (SGA) or large for gestational age (LGA) or having a small or large head circumference (HC) at birth is associated with adverse neurodevelopmental outcomes. STUDY DESIGN:  This is a secondary analysis of a multicenter negative randomized trial of thyroxine therapy for subclinical hypothyroid disorders in pregnancy. The primary outcome was child intelligence quotient (IQ) at 5 years of age...

BACKGROUND: Angiotensin-converting enzyme inhibitors and diuretics may be underutilized for postpartum hypertension because of their teratogenicity during pregnancy. OBJECTIVE: We evaluated whether combined oral hydrochlorothiazide and lisinopril therapy produced superior short-term blood pressure control when compared with nifedipine among postpartum individuals with hypertension requiring pharmacologic treatment. STUDY DESIGN: We performed a pilot randomized controlled trial (October 2021 to June 2022) that included individuals with chronic hypertension or hypertensive disorders of pregnancy with 2 systolic blood pressure measurements ≥150 mm Hg and/or diastolic blood pressure measurements ≥100 mm Hg within 72 hours after delivery...

OBJECTIVE:  This study aimed to ascertain the outcomes associated with a cervical cerclage among individuals with a history of previable prelabor rupture of membranes (PROM). STUDY DESIGN:  This study was a retrospective cohort study conducted at a single tertiary center between 2011 and 2021. We included individuals with a history of previable (before 24 weeks) PROM and the subsequent viable pregnancy. Women with multifetal gestation, preterm birth (PTB) or cerclage in previous gestation, or abdominal cerclage after trachelectomy were excluded...

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Though many multicenter clinical trials utilize an individual IRB model, where each institution uses their own local IRB, it is unknown if a shared (single IRB) model would reduce the time required to approve a standard IRB protocol. OBJECTIVE: The objective of this study was to compare processing times and other processing characteristics between sites using a single IRB and those using their own site IRBs in a multicenter clinical trial...

BACKGROUND: Better understanding of the factors associated with formula feeding during the hospital stay can help in identifying potential lactation problems and promote early intervention. Our aim was to ascertain factors associated with exclusive formula feeding in newborns of low-risk pregnancies. METHODS: A population-based, retrospective study using the United States vital statistics datasets (2014-2018) evaluating low-risk pregnancies with a nonanomalous singleton delivery from 37 to 41 weeks...

OBJECTIVE:  We aimed to ascertain whether the risk of adverse pregnancy outcomes in the United States among individuals with chronic hypertension differed by maternal race and ethnicity and to assess the temporal trend. STUDY DESIGN:  Population-based retrospective study using the U.S. Vital Statistics datasets evaluated pregnancies with chronic hypertension, singleton live births that delivered at 24 to 41 weeks. The coprimary outcomes were a composite maternal adverse outcome (preeclampsia, primary cesarean delivery, intensive care unit admission, blood transfusion, uterine rupture, or unplanned hysterectomy) and a composite neonatal adverse outcome (preterm birth, small for gestational age, Apgar's score <5 at 5 minutes, assisted ventilation> 6 hours, seizure, or death)...

OBJECTIVE: Our aim was to evaluate whether the risk for fetal malpresentation following mechanical labor induction could be accurately predicted. METHOD: A retrospective study, including all individuals that underwent labor induction at a single tertiary medical center between March 2011 and May 2021. Cohorts of pharmacological (n=16,480) and mechanical labor induction (n=6,864) were compared, determining malpresentation rate following induction. Individuals with and without fetal malpresentation following balloon placement were compared...

OBJECTIVE: To describe timing, antecedent events, and outcomes in pregnancy-related stroke (PAS). METHODS: Retrospective single-center cohort of all PAS within 42 days of delivery from September 2010 to May 2021. Data were abstracted from medical records. RESULTS: Among 51,500 births, we identified 91 cases of PAS, with a stroke rate of 177 per 100,000 births. Of all PAS, 62% were hemorrhagic, 56% occurred postpartum, 49% occurred in patients with hypertensive disorders of pregnancy (HDP), and 36% had surgical interventions...

This commentary discusses the issues related to conservative management (also called leaving the placenta in situ or intentional retention of the placenta) of placenta accreta spectrum disorders. Considerations related to placenta accreta spectrum disorder management in the United States are compared with France, where conservative management is a well-accepted management option. The history of placenta accreta spectrum disorder treatment is reviewed, finding that since 1937, the most common treatment in the United States been cesarean-hysterectomy without placental removal...

OBJECTIVE: The international consensus on continuous glucose monitoring (CGM) recommends time in range (TIR) target of >70% for pregnant people. Our aim was to compare outcomes between pregnant people with TIR ≤ versus >70%. STUDY DESIGN: Retrospective study of all people using CGM during pregnancy from January 2017 to May 2021 at a tertiary care center. All people with pregestational diabetes who used CGM and delivered at our center were included in the analysis...

OBJECTIVE:  The most common treatment for placenta accreta spectrum (PAS) disorders is planned primary cesarean hysterectomy. However, other management strategies may improve outcomes and/or allow fertility preservation. The objective of this study was to describe the course and outcomes of patients with PAS managed by leaving the placenta in situ. STUDY DESIGN:  This is a series of 11 patients with PAS managed by leaving the placenta in situ at a single academic center in the United States from 2015 to 2022...

OBJECTIVE: This study aimed to develop and evaluate a scoring system-called the Sepsis-Associated Adverse Outcomes in Pregnancy (SAAP) Score-to identify individuals with maternal infection that have composite maternal adverse outcomes (CMAO). STUDY DESIGN: Using the International Classification of Disease codes, we identified pregnant and postpartum (up to 6 weeks after birth) individuals admitted at our center with a primary diagnosis of infection. The primary outcome was CMAO which included any of the following: maternal intensive care unit admission, surgical intervention, vasopressor use, acute respiratory distress syndrome, pulmonary edema, mechanical ventilation, high-flow nasal cannula, disseminated intravascular coagulation, dialysis, organ failure, venous thromboembolism, or maternal death...

OBJECTIVE: To assess whether an intervention with a multimedia educational tool, compared with routine care, would increase the use of long-acting reversible contraceptives (LARC) at 12 weeks postpartum in individuals with high-risk pregnancies. METHODS: In this single-center randomized trial, we assigned individuals aged 13-50 years with high-risk pregnancies to either a multimedia educational tool or routine care. Participants were included during pregnancy through postpartum day 1...

BACKGROUND: The ability to diagnose preeclampsia clinically is suboptimal. Our objective was to validate a novel multianalyte assay and characterize its performance, when intended for use as an aid to rule-out preeclampsia. METHODS: Prospective, multicenter cohort study of pregnant individuals presenting between 280/7 and 366/7 weeks' with preeclampsia-associated signs and symptoms. Individuals not diagnosed with preeclampsia after baseline evaluation were enrolled in the study cohort, with those who later developed preeclampsia, classified as cases and compared with a negative control group who did not develop preeclampsia...

BACKGROUND: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth. METHODS: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group)...

BACKGROUND: Inpatient antepartum individuals have higher levels of anxiety compared to outpatient. Former randomized trials using mindful meditation programs to decrease maternal anxiety have conflicting results; some studies show significant decrease in anxiety levels, while others show no difference. A paucity of trials exist using mindful meditation for maternal anxiety in the inpatient antepartum population; most studies focus on the outpatient clinic population. Due to inpatient acuity and anxiety factors, we performed a randomized trial to target this population...