Publications by authors named "Sean C Blackwell"

194 Publications

The association of race and ethnicity with severe maternal morbidity among individuals diagnosed with hypertensive disorders of pregnancy.

Am J Perinatol 2022 Jun 28. Epub 2022 Jun 28.

Obstetrics & Gynecology, University of Texas Health Sciences Center at Houston, Houston, United States.

Objective: To examine racial disparities in severe maternal morbidity in patients with hypertensive disorder of pregnancy (HDP).

Study Design: Secondary analysis of an observational study of 115,502 patients who had a live birth at ≥ 20 weeks in 25 hospitals in the US, 2008-2011. Only patients with HDP were included in this analysis. Race and ethnicity were categorized as non-Hispanic White (NHW), non-Hispanic Black (NHB) and Hispanic. Associations were estimated between race and ethnicity and the primary outcome of severe maternal morbidity, defined as any of the following: blood transfusion ≥4 units, unexpected surgical procedure, need for a ventilator ≥ 12 hours, intensive care unit (ICU) admission, or failure of ≥ 1 organ system, were estimated by unadjusted logistic and multivariable backward logistic regressions. Multivariable models were run classifying HDP into 3 levels: 1) gestational hypertension; 2) preeclampsia (mild, severe or superimposed); and 3) eclampsia or HELLP.

Results: A total of 9,612 individuals with HDP were included. The frequency of the primary outcome, composite severe maternal morbidity, was higher in NHB patients compared with that in NHW or Hispanic patients (11.8% vs. 4.5% in NHW and 4.8% in Hispanic, p<0.001). This was driven by a higher frequency of blood transfusions and ICU admissions among NHB individuals. After adjusting for sociodemographic and clinical factors, hospital site, and the severity of HDP, the odds ratios of composite severe maternal morbidity did not differ between the groups (adjusted OR 1.26, 95% CI 0.95, 1.67 for NHB and adjusted OR 1.29, 95% CI 0.94, 1.77 for Hispanic, compared to NHW patients).

Conclusion: NHB patients with HDP had higher rates of the composite maternal morbidity compared with NHW, driven mainly by higher frequencies of blood transfusions and ICU admissions. However, once severity and other confounding factors were taken into account, the differences did not persist.
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http://dx.doi.org/10.1055/a-1886-5404DOI Listing
June 2022

Leaving the Placenta In Situ in Placenta Accreta Spectrum Disorders: A Single Center Case Series.

Am J Perinatol 2022 Jun 25. Epub 2022 Jun 25.

Obstetrics & Gynecology, University of Texas Health Sciences Center at Houston, Houston, United States.

The most common treatment for placenta accreta spectrum disorders (PAS) is planned primary cesarean-hysterectomy. However, other management strategies may improve outcomes and/or allow fertility preservation. This is a series of 11 patients with PAS managed by leaving the placenta in situ at a single academic center in the U.S. from 2015-2022. The approach described involves delivery of the fetus via cesarean, no attempt at placental removal, closure of the hysterotomy, prophylactic intravenous antibiotics for up to one week, and close outpatient follow up until the uterus is empty. The uterus was successfully preserved in 6 (55%), minimally invasive hysterectomy was performed in 4 (36%), and abdominal hysterectomy was performed in 1 (9%). During cesarean delivery, the median estimated blood loss was 650mL (range 200 - 1,000 mL). The majority of patients had no vaginal discharge for several weeks after delivery, followed by brown or bloody discharge, and intermittent mild-moderate cramping. The median time to resolution of PAS was 18 weeks in patients with successful uterine preservation (range 5 - 25 weeks). Indications for hysterectomy included hemorrhage (n=1), coagulopathy (n=1), endomyometritis (n=2), and pain (n=1), and these occurred at a median of 5 weeks postpartum (range 1 - 25 weeks). Four patients had subsequent pregnancies, of whom three were live births at or near term, and one was a spontaneous abortion at 19 weeks.
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http://dx.doi.org/10.1055/a-1885-1942DOI Listing
June 2022

Research Project Grants in obstetrics: publications and influence on practice guidelines.

Am J Obstet Gynecol MFM 2022 Jun 18;4(5):100679. Epub 2022 Jun 18.

Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX.

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http://dx.doi.org/10.1016/j.ajogmf.2022.100679DOI Listing
June 2022

Impact of Maternal-Fetal Medicine Units Network's publications on American College of Obstetricians and Gynecologists guidelines.

Am J Obstet Gynecol MFM 2022 Jun 16;4(5):100677. Epub 2022 Jun 16.

Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.

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http://dx.doi.org/10.1016/j.ajogmf.2022.100677DOI Listing
June 2022

ASSOCIATION OF MATERNAL BODY MASS INDEX AND MATERNAL MORBIDITY AND MORTALITY.

Am J Perinatol 2022 Jun 16. Epub 2022 Jun 16.

Oregon Health Sciences University, Portland, Portland, United States.

Objective: To assess the association of maternal BMI with a composite of severe maternal outcomes.

Study Design: Secondary analysis of a cohort of deliveries on randomly selected days at 25 hospitals from 2008-2011. Data on comorbid conditions, intrapartum events, and postpartum course were collected. The reference group (REF, BMI 18.5-29.9), obese (OB, BMI 30-39.9), morbidly obese (MO, BMI 40-49.9) and super morbidly obese (SMO, BMI  50) women were compared. The composite of severe maternal outcomes was defined as death, ICU admission, ventilator use, DVT/PE, sepsis, hemorrhage, DIC, unplanned operative procedure, or stroke. Patients in the REF group were matched 1:1 with those in all other obesity groups based on propensity score using the baseline characteristics of age, race-ethnicity, previous cesarean, pre-existing diabetes, chronic hypertension, parity, cigarette use, and insurance status. Multivariable Poisson regression was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI) for the association between BMI and the composite outcome. Because cesarean delivery may be in the causal pathway between obesity and adverse maternal outcomes, models were then adjusted for mode of delivery to evaluate potential mediation.

Results: A total of 52,162 pregnant patients are included in the analysis. Risk of composite maternal outcomes was increased for SMO compared with REF, but not for OB and MO [OB aRR 1.06 95%CI (0.99-1.14); MO aRR 1.10 (95%CI 0.97-1.25); SMO aRR 1.32 95%CI (1.02-1.70)]. However, in the mediation analysis, cesarean appears to mediate 46% (95%CI 31% - 50%) of the risk of severe morbidity for SMO compared with REF.

Conclusion: Super morbid obesity is significantly associated with increased serious maternal morbidity and mortality; however, cesarean appears to mediate this association. Obesity and morbid obesity are not associated with maternal morbidity and mortality.
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http://dx.doi.org/10.1055/a-1877-8918DOI Listing
June 2022

Differential Gene Expression in Cord Blood of Infants Diagnosed with Cerebral Palsy: a Pilot Analysis of the BEAM Cohort.

Dev Neurosci 2022 Jun 15. Epub 2022 Jun 15.

The Beneficial Effects of Antenatal Magnesium (BEAM) clinical trial was conducted between 1997-2007, and demonstrated a significant reduction in cerebral palsy (CP) in preterm infants who were exposed to peripartum magnesium sulfate (MgSO4). However, the mechanism by which MgSO4 confers neuroprotection remains incompletely understood. Cord blood samples from this study were interrogated during an era when next generation sequencing was not widely accessible and few gene expression differences or biomarkers were identified between treatment groups. Our goal was to use bulk RNA deep sequencing to identify differentially expressed genes comparing the following four groups: newborns who ultimately developed CP treated with MgSO4 or placebo, and controls (newborns who ultimately did not develop CP) treated with MgSO4 or placebo. Those who died after birth were excluded. We found that MgSO4 upregulated expression of SCN5A only in the control group, with no change in gene expression in cord blood of newborns who ultimately developed CP. Regardless of MgSO4 exposure, expression of NPBWR1 and FTO were upregulated in cord blood of newborns who ultimately developed CP compared with controls. These data support that MgSO4 may not exert its neuroprotective effect through changes in gene expression. Moreover, NPBWR1 and FTO may be useful as biomarkers, and may suggest new mechanistic pathways to pursue in understanding the pathogenesis of CP. The small number of cases ultimately available for this secondary analysis, with male predominance and mild CP phenotype, is a limitation of the study. In addition, differentially expressed genes were not validated by qRT-PCR.
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http://dx.doi.org/10.1159/000525483DOI Listing
June 2022

Educational Multimedia Tool Compared With Routine Care for the Uptake of Postpartum Long-Acting Reversible Contraception in Individuals With High-Risk Pregnancies: A Randomized Controlled Trial.

Obstet Gynecol 2022 04 10;139(4):571-578. Epub 2022 Mar 10.

Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas; and the Department of Obstetrics and Gynecology, Alpert Medical School, Brown University, Providence, Rhode Island.

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. Those randomized to the multimedia educational tool (MET) group were provided a tablet with the preloaded 3-5-minute multimedia presentation (https://prezi.com/view/jpFrXaPnnxuqRkcI3A4a/), which was viewed without the presence of research staff and resent by secure email every 4 weeks if undelivered. The primary outcome was uptake of LARC (implant or intrauterine device) within 12 weeks of delivery. The secondary outcomes included overall use of any method of contraception and composite maternal and neonatal adverse outcomes. A priori estimates indicated that 380 participants were needed to detect a 40% difference in use of LARC (baseline 40%; alpha=0.05, power=0.8, assumed loss to follow-up 20%). Relative risk (RR) and number needed to treat (NNT), along with 95% CIs, were calculated.

Results: From July 2020 through December 2020, 536 persons were screened and 380 randomized as follows: 190 for the multimedia educational tool and 190 for routine care. Demographic characteristics were similar between groups. The primary outcome-available for more than 90% of participants-was higher in the MET group (32.4%) than in the routine care (RC) group (20.9%) (RR 1.55; 95% CI 1.09-2.21; NNT nine, with 95% CI 5-42). Overall use of contraception was also higher in the MET group than in the RC group (RR 1.16; 95% CI 1.03-1.32).

Conclusion: Among individuals with high-risk pregnancies, compared with routine care, use of a multimedia-based educational tool increased the uptake of postpartum LARC by 55%.

Clinical Trial Registration: ClinicalTrials.gov, NCT04291040.

Funding Source: Funded in part by Investigator-Initiated studies of Organon.
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http://dx.doi.org/10.1097/AOG.0000000000004718DOI Listing
April 2022

Michigan Plan for Appropriate Tailored Healthcare in Pregnancy Prenatal Care Recommendations: A Practical Guide for Maternity Care Clinicians.

J Womens Health (Larchmt) 2022 07 12;31(7):917-925. Epub 2022 May 12.

American College of Obstetricians and Gynecologists, Washington, District of Columbia, USA.

Prenatal care is an important preventive service designed to improve the health of pregnant patients and their infants. Prenatal care delivery recommendations have remained unchanged since 1930, when the 12-14 in-person visit schedule was first established to detect preeclampsia. In 2020, the American College of Obstetricians and Gynecologists, in collaboration with the University of Michigan, convened a panel of maternity care experts to determine new prenatal care delivery recommendations. The panel recognized the need to include emerging evidence and experience, including significant changes in prenatal care delivery during the COVID-19 pandemic, pre-existing knowledge of the importance of individualized care plans, the promise of telemedicine, and the significant influence of social and structural determinants of health (SSDoH) on pregnancy outcomes. Recommendations were derived using the RAND-UCLA appropriateness method, a rigorous e-Delphi method, and are designed to extend beyond the acute public health crisis. The resulting includes recommendations for key aspects of prenatal care delivery: (1) the recommended number of prenatal visits, (2) the frequency of prenatal visits, (3) the role of monitoring routine pregnancy parameters (blood pressure, fetal heart tones, weight, and fundal height), (4) integration of telemedicine into routine care, and (5) inclusion of (SSDoH). Resulting recommendations demonstrate a new approach to prenatal care delivery that incorporates medical, SSDoH, and patient preferences, to develop individualized prenatal care delivery plans. The purpose of this document is to outline the new MiPATH recommendations and to provide practical guidance on implementing them in routine practice.
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http://dx.doi.org/10.1089/jwh.2021.0589DOI Listing
July 2022

Maternal Diabetes and Intrapartum Fetal Electrocardiogram.

Am J Perinatol 2022 04 5. Epub 2022 Apr 5.

University of Pittsburgh, Pittsburgh, Pennsylvania.

Objective: Fetal electrocardiogram (ECG) ST changes are associated with fetal cardiac hypoxia. Our objective was to evaluate ST changes by maternal diabetic status and stage of labor.

Methods: This was a secondary analysis of a multicentered randomized-controlled trial in which laboring patients with singleton gestations underwent fetal ECG scalp electrode placement and were randomly assigned to masked or unmasked ST-segment readings. Our primary outcome was the frequency of fetal ECG tracings with ST changes by the stage of labor. ECG tracings were categorized into mutually exclusive groups (ST depression, ST elevation without ST depression, or no ST changes). We compared participants with DM, gestational diabetes mellitus (GDM), and no DM.

Results: Of the 5,436 eligible individuals in the first stage of labor (95 with pregestational DM and 370 with GDM), 4,427 progressed to the second stage. ST depression occurred more frequently in the first stage of labor in participants with pregestational DM (15%, adjusted odds ratio [aOR] 2.20, 95% confidence interval [CI] 1.14-4.24) and with GDM (9.5%, aOR 1.51, 95% CI 1.02-2.25) as compared with participants without DM (5.7%). The frequency of ST elevation was similar in participants with pregestational DM (33%, aOR 0.79, 95% CI 0.48-1.30) and GDM (33.2%, aOR 0.91, 95% CI 0.71-1.17) as compared with those without DM (34.2%). In the second stage, ST depression did not occur in participants with pregestational DM (0%) and occurred more frequently in participants with GDM (3.5%, aOR 2.01, 95% CI 1.02-3.98) as compared with those without DM (2.0%). ST elevation occurred more frequently in participants with pregestational DM (30%, aOR 1.81, 95% CI 1.02-3.22) but not with GDM (19.0%, aOR 1.06, 95% CI 0.77-1.47) as compared with those without DM (17.8%).

Conclusion: ST changes in fetal ECG occur more frequently in fetuses of diabetic mothers during labor.

Clinicaltrials: gov number, NCT01131260.

Precis: ST changes in fetal ECG, a marker of fetal cardiac hypoxia, occur more frequently in fetuses of diabetic parturients.

Key Points: · Fetal hypertrophic cardiomyopathy (HCM) and cardiac dysfunction occur frequently among fetuses of diabetic patients.. · Fetal ECG changes such as ST elevation and depression reflect cardiac hypoxia.. · Fetuses of diabetic patients demonstrate a higher prevalence of fetal ECG tracings with ST changes..
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http://dx.doi.org/10.1055/a-1817-5788DOI Listing
April 2022

Implementing a Universal Cervical Length Screening Program in a Large Hospital System: It Takes Some Time to Achieve Consistent Results.

Gynecol Obstet Invest 2022 30;87(2):124-132. Epub 2022 Mar 30.

Department of Obstetrics and Gynecology and Reproductive Sciences, McGovern Medical School, University of Texas, Health Science Center at Houston (UTHealth), Houston, Texas, USA.

Objective: The aim of the study was to describe changes in the acceptance of transvaginal (TV) cervical length (CL) assessment and in the variance of CL measurements among operators, after implementation of universal TV-CL screening at 18+0 - to 23+6 weeks/days of gestation.

Design: Retrospective cohort.

Participants/materials, Setting, Methods: This study was performed after universal TV-CL screening was implemented at the University of Texas Health Science Center in Houston, TX, USA, for all women undergoing an anatomy ultrasound (US) between 18 0/6 and 23 6/7 weeks/days of gestation. Pregnant women carrying singletons without prior history of preterm delivery who underwent anatomy US evaluation between September 2017 and March 2020 (30 months) were included. The complete study period was divided into five epochs of 6 months each. Changes in patient's acceptance for the TV scan, in CL distribution, in the prevalence of short cervix defined as ≤15, ≤20, or ≤25 mm, and in the performance of US operators across the five epochs were evaluated. Success rate was defined as the percentage of TV-CL measurements obtained in relation to the number of second-trimester anatomy scans.

Results: A total of 22,207 low-risk pregnant women evaluated by 36 trained sonographers (operators) were analyzed. Overall, the acceptance for TV-CL measurement was 82.3% (18,289/22,207), increasing from 76.7% in the first epoch to 82.8% (p < 0.0001) in the last epoch. The mean CL did not significantly change from 38.6 mm in the first epoch to 38.5 mm in the last epoch (p = 0.7); however, the standard deviation decreased from 7.9 mm in the first epoch to 7.04 mm in the last epoch (p = <0.01). The prevalence of a short cervix ≤25 mm was 2.2% (n = 399/18,289), ≤20 mm was 1.2% (224/18,289), and ≤15 mm was 0.9% (162/18,289). This prevalence varied only for CL ≤25 mm from 3.02% (88/2,907) in the first epoch to 1.77% (64/3,615) in the last epoch (p = 0.0009). There was a variation in CL measurements among operators (mean 3.3 mm). Sonographers with less than 1 year of experience had a lower success rate for completing TV-CL examinations than more experienced sonographers (80.8% vs. 85.8%; p < 0.03). In general, 77% (27/35) of operators had a success rate ≥80% for completing TV-CL scans.

Limitations: Characteristics of individuals who accepted versus those who declined TV-CL were not compared; CL values were not correlated with clinical outcomes.

Conclusions: During the first 6 months after implementation of a universal CL screening program, there was greater variation in CL measurements, lower acceptance for TV US, and a higher number of women diagnosed with a CL ≤25 mm, as compared to subsequent epochs. After the first 6 months, these metrics improved and remained stable. Most operators improved their performance over time; however, there were a few with a low success rate for TV-CL and others who systematically over- or underestimate CL measurements.
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http://dx.doi.org/10.1159/000524361DOI Listing
June 2022

Timing of Maternal Discharge after Cesarean Delivery and Risk of Maternal Readmission.

Am J Perinatol 2022 07 4;39(10):1042-1047. Epub 2022 Mar 4.

Birmingham, Alabama.

Objective: Despite legislation and hospital policies (present in some institutions) mandating a minimum length of stay in an effort to decrease the frequency of hospital readmissions, the effectiveness of this approach remains uncertain.We hypothesized that following cesarean delivery (CD), the rates of maternal readmission or unscheduled health care visits are lower in patients discharged on postoperative day (POD) 3 or ≥4 as compared with those discharged earlier on POD 2.

Methods: This is a secondary analysis of a multicenter randomized trial comparing adjunctive azithromycin for unscheduled CD to prevent infection. Groups were compared based on the duration of hospitalization measured in days from delivery (POD 0) to day of discharge and categorized as POD 2, 3, and ≥4. The primary outcome was the composite of any maternal postpartum readmission, unscheduled clinic, or emergency room (ER) visit, within 6 weeks of delivery. Secondary outcomes included components of the primary outcome and neonatal readmissions. We excluded women with hypertensive disorders of pregnancy and infections diagnosed prior to POD 2.

Results: A total of 1,391 patients were included. The rate of the primary outcome of any readmission increased with POD at discharge: 5.9% for POD 2, 9.4% for POD 3, and 10.9% for POD ≥4 group (trend for  = 0.03). The primary outcome increased with later discharge (POD ≥4 when compared with POD 2). Among components of the composite, ER and unscheduled clinic visits, but not maternal readmissions, increased with the timing of discharge for patients discharged on POD ≥4 when compared with POD 2. Using logistic regression, discharge on POD 3 and on POD ≥4 was significantly associated with the composite (adjusted odds ratios [aOR] 2.6, 95% confidence interval [CI] [1.3-5.3]; aOR 2.9, 95% CI [1.3-6.4], respectively) compared with POD 2.

Conclusion: The risk of maternal readmission composite following uncomplicated but unscheduled CD was not lower in patients discharged home on POD 3 or ≥4 compared with patients discharged earlier (POD 2).

Key Points: · Risk of maternal readmission is higher in patients discharged on POD 3 or 4 compared with POD 2.. · No significant differences by the timing of discharge were observed for any neonatal readmissions.. · Timing of discharge should include an individualized approach with the option of discharge by POD 2..
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http://dx.doi.org/10.1055/s-0042-1743248DOI Listing
July 2022

Predictive performance of newborn small for gestational age by a United States intrauterine vs birthweight-derived standard for short-term neonatal morbidity and mortality.

Am J Obstet Gynecol MFM 2022 05 18;4(3):100599. Epub 2022 Feb 18.

Background: The use of birthweight standards to define small for gestational age may fail to identify neonates affected by poor fetal growth as they include births associated with suboptimal fetal growth.

Objective: This study aimed to compare intrauterine vs birthweight-derived standards to define newborn small for gestational age to predict neonatal morbidity and mortality.

Study Design: This was a secondary analysis of a multicenter observational study of 118,422 births. Live-born singleton, nonanomalous newborns born at 23 to 41 weeks of gestation were included. Those with missing gestational age estimation or without a first- or second-trimester ultrasound to confirm dating, birthweight, or neonatal outcome data were excluded. Birthweight percentile was computed using an intrauterine standard (Hadlock) and a birthweight-derived standard (Olsen). We compared the test characteristics of small for gestational age (birthweight of <10th percentile) by each standard to predict a composite neonatal morbidity and mortality outcome (death before discharge, neonatal intensive care unit admission >48 hours, respiratory distress syndrome, sepsis, necrotizing enterocolitis, grade 3 or 4 intraventricular hemorrhage, or seizures). Severe composite morbidity was analyzed as a secondary outcome and was defined as death, neonatal intensive care unit admission >7 days, necrotizing enterocolitis, grade 3 or 4 intraventricular hemorrhage, or seizures. The areas under the curve using receiver-operating characteristic methodology and proportions of the primary outcome by small for gestational age status were compared by gestational age category at birth (<34, 34 0/7 to 36 6/7, ≥37 weeks).

Results: Of 115,502 mother-newborn dyads in the parent study, 78,203 (67.7%) were included, with most exclusions occurring because of missing or inadequate dating information, multiple gestations, or delivery outside the gestational age range. The primary composite outcome occurred in 9.5% (95% confidence interval, 9.3-9.7), and the severe composite outcome occurred in 5.3% (95% confidence interval, 5.1-5.4). Small for gestational age was diagnosed by intrauterine and birthweight-derived standards in 14.8% and 7.4%, respectively (P<.001). Neonates considered small for gestational age only by the intrauterine standard experienced the primary outcome more than twice as often as those considered non-small for gestational age by both standards (18.4% vs 7.9%; P<.001). For the prediction of the primary outcome, small for gestational age by the intrauterine standard had higher sensitivity (29% vs 15%; P<.001) but lower specificity (87% vs 93%; P<.001) than by the birthweight standard. Both standards had weak performance overall, although the intrauterine standard had a higher area under the curve (0.58 vs 0.53; P<.001). When subanalyzed by gestational age at birth, the difference in areas under the curve was only present among preterm deliveries 34 to 36 competed weeks. Neither standard demonstrated any discrimination for morbidity prediction among term births (area under the curve, 0.50 for both). When the prediction of severe morbidity was compared, the intrauterine still had better overall prediction than the birthweight standard (areas under the curve, 0.65 vs 0.57; P<.001), although this also varied by gestational age at birth.

Conclusion: Among nonanomalous neonates, neither intrauterine nor birthweight-derived standards for small for gestational age accurately predicted neonatal morbidity and mortality, with no discriminatory ability at term. Small for gestational age intrauterine standards performed better than birthweight standards.
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http://dx.doi.org/10.1016/j.ajogmf.2022.100599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097811PMC
May 2022

An evaluation of seasonal maternal-neonatal morbidity related to trainee cycles.

Am J Obstet Gynecol MFM 2022 05 2;4(3):100583. Epub 2022 Feb 2.

Department of Obstetrics & Gynecology, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, TX (Dr Blackwell).

Background: The existence of the "July phenomenon" (worse outcomes related to the presence of new physician trainees in teaching hospitals) has been debated in the literature and media. Previous studies of the phenomenon in obstetrics are limited by the quality and detail of data.

Objective: To evaluate whether the months of June to August, when transitions in trainees occur, are associated with increased maternal and neonatal morbidity.

Study Design: Secondary analysis of an observational cohort of 115,502 mother-infant pairs that delivered at 25 hospitals from March 2008 to February 2011. Inclusion criteria were an individual who had a singleton, nonanomalous live fetus at the onset of labor, and delivered at a hospital with trainees. The primary outcomes were composites of maternal and neonatal morbidity. We evaluated the outcomes by academic quarter during which the delivery occurred, beginning July 1, and by duration of the academic year as a continuous variable. To account for clustering in outcomes at a given delivery location, we applied hierarchical logistic regression with adjustment for hospital as a random effect.

Results: Of 115,502 deliveries, 99,929 met the inclusion criteria. Race and ethnicity, insurance, body mass index, drug use, and the availability of 24/7 maternal-fetal medicine, anesthesia, and neonatology varied by quarter. In adjusted analysis, the frequency of the composite maternal and neonatal morbidity did not differ by quarter. No differences in composite morbidity were observed when using day of the year as a continuous variable (maternal morbidity adjusted odds ratio, 1.00; 95% confidence interval, 0.99-1.00 and neonatal morbidity adjusted odds ratio, 1.00; 95% confidence interval, 1.00-1.01) and after adjustment for hospital as a random effect. Odds of major surgical complications in quarter 2 were twice those in quarter 1. Neonatal injury and intensive care unit were less frequent in later quarters.

Conclusion: Maternal and neonatal morbidity in teaching hospitals was not associated with the academic quarter during which delivery occurred, and there was no evidence of a "July phenomenon".
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http://dx.doi.org/10.1016/j.ajogmf.2022.100583DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9081218PMC
May 2022

Accuracy of baseline prevalence estimates for sample size calculations in obstetrical randomized controlled trials.

Am J Obstet Gynecol 2022 06 2;226(6):855-856. Epub 2022 Feb 2.

Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.

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http://dx.doi.org/10.1016/j.ajog.2022.01.032DOI Listing
June 2022

Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE).

Am J Obstet Gynecol MFM 2022 05 12;4(3):100562. Epub 2022 Jan 12.

Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).

Background: Inpatient antepartum women have higher levels of anxiety than outpatient. Former randomized trials using mindful meditation programs to decrease maternal anxiety have conflicting results; some studies showed a considerable decrease in anxiety levels, whereas others showed 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. Because of inpatient acuity and anxiety factors, we conducted a randomized trial to target this population.

Objective: This study aimed to compare anxiety levels on day 4 of either routine care or routine care plus a twice-daily application-based mindful meditation program in women admitted to the antepartum unit.

Study Design: In a multisite randomized trial (ClinicalTrials.gov Identifier: NCT03737279), women admitted to the antepartum units were randomized to either routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm). The inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for >3 days from randomization, and care by our university physician team. The primary outcome was maternal state anxiety level (measured using the validated State-Trait Anxiety Inventory) on day 4 (randomization being day 1). The secondary outcomes included stress (measured using the Perceived Stress Scale) and depression (measured using the Edinburgh Depression Scale) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time. A total of 56 women were needed for 90% power to detect a decrease in the primary outcome by 30% in the intervention group, compared with the control group. All women were observed using an intention-to-treat analysis. We compared the continuous variables using the Wilcoxon rank-sum test or t test and the categorical variables using the chi-squared test or the Fisher exact test.

Results: From March 4, 2019, to December 20, 2019, 412 women were screened for eligibility, 77 women (18.7%) were found eligible, and 56 women (72.7%) were randomized with 28 women in each group. Of note, 96.4% of women completed at least 1 meditation session, and 39.3% of women completed all meditation sessions. The mean score of the anxiety level using the State-Trait Anxiety Inventory on day 4 was not significantly different (P=.24) between the control group (42.0±10.8) and meditation group (37.5±13.1). A decreased anxiety score from day 1 to day 4 was seen in both the control group and meditation group (-4.7 vs -9.4, respectively; P=.12). The rate of abnormal State-Trait Anxiety Inventory scores on day 4 was not significantly different between the control group and meditation group (62% vs 45%, respectively; P=.28). When asked about the experience with the research trial, 88.8% of women in the control group and 89.5% of women in the meditation group reported a positive experience.

Conclusion: Compared with the control group, a twice-daily application-based mindful meditation program for women admitted to the antepartum unit did not considerably decrease the anxiety score on day 4. However, >88% of women in both groups had a positive experience with the nonpharmacologic intervention.
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http://dx.doi.org/10.1016/j.ajogmf.2022.100562DOI Listing
May 2022

Neonatal Birthweight, Infant Feeding, and Childhood Metabolic Markers.

Am J Perinatol 2022 04 16;39(6):584-591. Epub 2021 Dec 16.

University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.

Objective: Antenatal and early neonatal nutritional environment may influence later metabolic health. Infants of mothers with gestational diabetes mellitus (GDM) have higher risk for childhood obesity and metabolic syndrome (MetS). Leptin and adiponectin are known biomarkers for MetS and may guide interventions to reduce later obesity. We sought to examine the relationship between birthweight, early infancy feeding practices, and biomarkers for MetS in offspring of women with mild GDM.

Study Design: Secondary analysis of a prospective observational follow-up study on the offspring of women who participated in a multicenter randomized treatment trial on mild GDM. Children were evaluated by research coordinators and biospecimens collected at the age of 5 to 10. Plasma concentrations of leptin and adiponectin were compared between large for gestational age (LGA) and average birthweight (AGA) infants, and according to whether solid foods were introduced early (<6 months of age) or at the recommended age (≥6 months of age). Multivariable analysis adjusted for fetal sex, race/ethnicity, and maternal body mass index.

Results: Leptin and adiponectin were measured in 336 plasma samples. In bivariate analysis, compared with AGA children, LGA children had lower leptin (5.0 ng/mL [3.6-6.0] vs. 5.8 ng/mL [4.5 = 6.6],  = 0.01) and similar adiponectin (6.3 µg/mL [5.1-7.9] vs. 6.4 µg/mL [5.3-8.6],  = 0.49) concentrations. Maternal/child characteristics were similar between the early/delayed solid feeding groups. Leptin and adiponectin concentrations were similar in the early fed and delayed feeding groups (5.8 ng/mL [4.6-6.7] vs. 5.6 ng/mL [4.2-6.6],  = 0.50 and 6.4 µg/mL [5.4-8.1] vs. 6.4 µg/mL [5.1-8.8],  = 0.85, respectively). After controlling for covariates, children who were LGA and AGA at birth had similar leptin concentrations.

Conclusion: Birthweight and early infancy feeding practice are not associated with alterations in leptin and adiponectin in children of women with mild GDM.

Key Points: · Adipocytokines are markers of metabolic status.. · Children of women with mild GDM may be at risk for MetS.. · Biomarkers similar in LGA and AGA groups.. · Biomarkers similar in early and delayed solid-fed groups.. · Nonhuman milk does not modify effect of feeding practice..
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http://dx.doi.org/10.1055/s-0041-1740056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9106839PMC
April 2022

Oral Glucose Tolerance Test in Pregnancy and Subsequent Maternal Hypertension.

Am J Perinatol 2021 Nov 16. Epub 2021 Nov 16.

Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.

Objective:  The aim of the study is to evaluate whether values and the shape of the glucose curve during the oral glucose tolerance test (OGTT) in pregnancy identify women at risk of developing hypertension (HTN) later in life.

Methods:  This category includes the secondary analysis of a follow-up from a mild gestational diabetes mellitus (GDM) study that included a treatment trial for mild GDM ( = 458) and an observational cohort of participants with abnormal 1-hour glucose loading test only (normal OGTT,  = 430). Participants were assessed at a median of 7 (IQR 6-8) years after their index pregnancy, and trained staff measured their blood pressure (systolic blood pressure [SBP]; diastolic blood pressure [DBP]). The association between values and the shape of the glucose curve during OGTT in the index pregnancy and the primary outcome defined as elevated BP (SBP ≥120, DBP ≥80 mm Hg, or receiving anti-HTN medications), and secondary outcome defined as stage 1 or higher (SBP ≥130, DBP ≥80 mm Hg, or receiving anti-HTN medications) at follow-up were evaluated using multivariable regression, adjusting for maternal age, body mass index, and pregnancy-associated hypertension during the index pregnancy.

Results:  There was no association between fasting, 1-hour OGTT, and the outcomes. However, the 2-hour OGTT value was positively associated (adjusted odds ratio [aRR] per 10-unit increase 1.04, 95% CI 1.01-1.08), and the 3-hour was inversely associated (aRR per 10-unit increase 0.96, 95% CI 0.93-0.99) with the primary outcome. When the shape of the OGTT curve was evaluated, a monophasic OGTT response (peak at 1 hour followed by a decline in glucose) was associated with increased risk of elevated BP (41.3vs. 23.5%, aRR 1.66, 95% CI 1.17-2.35) and stage 1 HTN or higher (28.5 vs. 14.7%, aRR 1.83, 95% CI 1.15-2.92), compared with a biphasic OGTT response.

Conclusion:  Among persons with mild GDM or lesser degrees of glucose intolerance, the shape of the OGTT curve during pregnancy may help identify women who are at risk of HTN later in life, with biphasic shape to be associated with lower risk.

Key Points: · The shape of the Oral Glucose Tolerance Test curve may help identify patients who are at risk of having elevated BP or HTN 5 to 10 years following pregnancy.. · The 2-hour Oral Glucose Tolerance Test values is positively associated with elevated BP 5 to 10 years following pregnancy.. · This supports the concept of pregnancy as a window to future health and represents a potential novel biomarker for maternal cardiovascular health screening..
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http://dx.doi.org/10.1055/s-0041-1740007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108113PMC
November 2021

Intrapartum Fetal Electrocardiogram in Small- and Large-for-Gestational Age Fetuses.

Am J Perinatol 2021 12 31;38(14):1465-1471. Epub 2021 Aug 31.

Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.

Objective: This study aimed to evaluate whether intrapartum fetal electrocardiogram (ECG) tracings with ST-elevation or depression occur more frequently in each stage of labor in small-for-gestational age (SGA) or large-for-gestational age (LGA), as compared with appropriate-for-gestational age (AGA) fetuses.

Study Design: We conducted a secondary analysis of a large, multicenter trial in which laboring patients underwent fetal ECG waveform-analysis. We excluded participants with diabetes mellitus and major fetal anomalies. Birth weight was categorized as SGA (<10th percentile), LGA (>90th percentile), or AGA (10-90th percentile) by using a gender and race/ethnicity specific nomogram. In adjusted analyses, the frequency of ECG tracings with ST-depression or ST-elevation without depression was compared according to birthweight categories and labor stage.

Results: Our study included 4,971 laboring patients in the first stage and 4,074 in the second stage. During the first stage of labor, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (6.7 vs. 5.5%; adjusted odds ratio [aOR]: 1.41, 95% confidence interval [CI]: 0.93-2.13), or in ST-elevation without depression (35.8 vs. 34.1%; aOR: 1.17, 95% CI: 0.94-1.46). During the second stage, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (1.6 vs. 2.0%; aOR: 0.69, 95% CI: 0.27-1.73), or in ST-elevation without depression (16.2 vs. 18.1%; aOR: 0.90, 95% CI: 0.67-1.22). During the first stage of labor, there were no differences in the frequency of ST-depression in LGA fetuses compared with AGA fetuses (6.3 vs. 5.5%; aOR: 0.97, 95% CI: 0.60-1.57), or in ST-elevation without depression (33.1 vs. 34.1%; aOR: 0.80, 95% CI: 0.62-1.03); during the second stage of labor, the frequency of ST-depression in LGA compared with AGA fetuses (2.5 vs. 2.0%, aOR: 1.36, 95% CI: 0.61-3.03), and in ST-elevation without depression (15.5 vs. 18.1%; aOR: 0.83, 95% CI: 0.58-1.18) were similar as well.

Conclusion: The frequency of intrapartum fetal ECG tracings with ST-events is similar among SGA, AGA, and LGA fetuses.

Key Points: · SGA and LGA neonates are at increased risk of cardiac dysfunction.. · Fetal ECG has been used to evaluate fetal response to hypoxia.. · Fetal ST-elevation and ST-depression occur during hypoxia.. · Frequency of intrapartum ST-events is similar among SGA, AGA and LGA fetuses..
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http://dx.doi.org/10.1055/s-0041-1735285DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8608729PMC
December 2021

Intrapartum Resuscitation Interventions for Category II Fetal Heart Rate Tracings and Improvement to Category I.

Obstet Gynecol 2021 09;138(3):409-416

Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD; the Departments of Obstetrics and Gynecology, the University of Texas Medical Branch at Galveston, Galveston, Texas, the University of Utah Health Sciences Center, Salt Lake City, Utah, the University of Texas McGovern Medical School at UT Health, Houston, Texas, the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, the University of Alabama at Birmingham, Birmingham, Alabama, Columbia University, New York, New York, Northwestern University, Chicago, Illinois, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Brown University, Providence, Rhode Island, Stanford University, Stanford, California, Wayne State University, Detroit, Michigan, and the University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.

Objective: To evaluate intrapartum resuscitation interventions and improvement in category II fetal heart rate (FHR) tracings.

Methods: This secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis included all participants with category II FHR tracings undergoing intrauterine resuscitation: maternal oxygen, intravenous fluid bolus, amnioinfusion, or tocolytic administration. Fetal heart rate pattern-recognition software was used to confirm category II FHR tracings 30 minutes before intervention and to analyze the subsequent 60 minutes. The primary outcome was improvement to category I within 60 minutes. Secondary outcomes included FHR tracing improvement to category I 30-60 minutes after the intervention and composite neonatal outcome.

Results: Of 11,108 randomized participants, 2,251 (20.3%) had at least one qualifying intervention for category II FHR tracings: 63.7% improved to category I within 60 minutes and 50.5% improved at 30-60 minutes. Only 3.4% underwent cesarean delivery and 4.1% an operative vaginal delivery for nonreassuring fetal status within 60 minutes after the intervention. Oxygen administration was the most common intervention (75.4%). Among American College of Obstetricians and Gynecologists-defined subgroups that received oxygen, the absent FHR accelerations and absent-minimal FHR variability subgroup (n=332) was more likely to convert to category I within 60 minutes than the FHR accelerations or "moderate FHR variability" subgroup (n=1,919) (77.0% vs 63.0%, odds ratio [OR] 2.0, 95% CI 1.4-2.7). The incidence of composite neonatal adverse outcome for category II tracings was 2.9% (95% CI 2.2-3.7%) overall; 2.8% (95% CI 2.0-3.8%) for improvement to category I within 60 minutes (n=1,433); and 3.2% (95% CI 2.1-4.6%) for no improvement within 60 minutes (n=818). However, the group with improvement had 29% lower odds for higher level neonatal care (11.8% vs 15.9%, OR 0.71, 95% CI 0.55-0.91).

Conclusion: Nearly two thirds of category II FHR tracings improved to category I within 60 minutes of intervention with a relatively low overall rate of the composite neonatal adverse outcome.

Funding Source: Funded in part by Neoventa Medical.
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http://dx.doi.org/10.1097/AOG.0000000000004508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8506980PMC
September 2021

Evaluation of Hypoglycemia in Neonates of Women at Risk for Late Preterm Delivery: An Antenatal Late Preterm Steroids Trial Cohort Study.

Am J Perinatol 2021 May 27. Epub 2021 May 27.

Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.

Objective:  In the antenatal late preterm steroids (ALPS) trial betamethasone significantly decreased short-term neonatal respiratory morbidity but increased the risk of neonatal hypoglycemia, diagnosed only categorically (<40 mg/dL). We sought to better characterize the nature, duration, and treatment for hypoglycemia.

Study Design:  Secondary analysis of infants from ALPS, a multicenter trial randomizing women at risk for late preterm delivery to betamethasone or placebo. This study was a reabstraction of all available charts from the parent trial, all of which were requested. Unreviewed charts included those lost to follow-up or from sites not participating in the reabstraction. Duration of hypoglycemia (<40 mg/dL), lowest value and treatment, if any, were assessed by group. Measures of association and regression models were used where appropriate.

Results:  Of 2,831 randomized, 2,609 (92.2%) were included. There were 387 (29.3%) and 223 (17.3%) with hypoglycemia in the betamethasone and placebo groups, respectively (relative risk [RR]: 1.69, 95% confidence interval [CI]: 1.46-1.96). Hypoglycemia generally occurred in the first 24 hours in both groups: 374/385 (97.1%) in the betamethasone group and 214/222 (96.4%) in the placebo group ( = 0.63). Of 387 neonates with hypoglycemia in the betamethasone group, 132 (34.1%) received treatment, while 73/223 (32.7%) received treatment in placebo group ( = 0.73). The lowest recorded blood sugar was similar between groups. Most hypoglycemia resolved by 24 hours in both (93.0 vs. 89.3% in the betamethasone and placebo groups, respectively,  = 0.18). Among infants with hypoglycemia in the first 24 hours, the time to resolution was shorter in the betamethasone group (2.80 [interquartile range: 2.03-7.03) vs. 3.74 (interquartile range: 2.15-15.08) hours;  = 0.002]. Persistence for >72 hours was rare and similar in both groups, nine (2.4%, betamethasone) and four (1.9%, placebo,  = 0.18).

Conclusion:  In this cohort, hypoglycemia was transient and most received no treatment, with a quicker resolution in the betamethasone group. Prolonged hypoglycemia was uncommon irrespective of steroid exposure.

Key Points: · Hypoglycemia was transient and approximately two-thirds received no treatment.. · Neonates in the ALPS trial who received betamethasone had a shorter time to resolution than those with hypoglycemia in the placebo group.. · Prolonged hypoglycemia occurred in approximately 2 out of 100 late preterm newborns, irrespective of antenatal steroid exposure..
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http://dx.doi.org/10.1055/s-0041-1729561DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8626537PMC
May 2021

Interventions to decrease complications after shoulder dystocia: a systematic review and Bayesian meta-analysis.

Am J Obstet Gynecol 2021 11 18;225(5):484.e1-484.e33. Epub 2021 May 18.

Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at UTHealth, Houston, TX. Electronic address:

Objective: This study aimed to evaluate the outcomes associated with the implementation of simulation exercises to reduce the sequela of shoulder dystocia.

Data Sources: Electronic databases (Ovid MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature database, and Scopus) were initially queried in June 2020 and updated in November 2020. The following 3 concepts were introduced and refined using the controlled vocabulary of the database: vaginal birth, shoulder dystocia, and simulation training. There were no limitations to the year of publication as part of the search strategy.

Study Eligibility Criteria: We included all studies that reported on the frequency of shoulder dystocia and the associated complications before and after the implementation of interventional exercises to improve outcomes.

Methods: Two authors independently assessed the abstracts and full-text articles of all studies for eligibility and evaluated the quality of the included studies using the Newcastle-Ottawa Scale. Any inconsistencies related to study evaluation or data extraction were resolved by a third author. The coprimary outcomes of this systematic review and meta-analysis were neonatal brachial plexus palsy diagnosed following deliveries complicated by shoulder dystocia and persistence of brachial palsy at 12 months or later. The secondary outcomes were the frequency of shoulder dystocia and cesarean delivery. Study effects were combined using a Bayesian meta-analysis and were reported as risk ratios and 95% credible intervals (Crs).

Results: Of the 372 articles reviewed, 16 publications, which included 428,552 deliveries with 217,713 (50.8%) deliveries during the preintervention and 210,839 (49.2%) deliveries during the postinterventional period, were included in the meta-analysis. The incidence of neonatal brachial plexus palsy after shoulder dystocia decreased from 12.1% to 5.7% (risk ratio, 0.37; 95% Cr, 0.26-0.57; probability of reduction 100%). The overall proportion of neonatal brachial plexus palsy decreased, but with less precision, from 0.3% to 0.1% (risk ratio, 0.53; 95% Cr, 0.21-1.26; probability of reduction 94%). Two studies followed newborns with brachial plexus palsy for at least 12 months. One study that reported on persistent neonatal brachial plexus palsy at 12 months among 1148 shoulder dystocia cases noted a reduction in persistent neonatal brachial plexus palsy from 1.9% to 0.2% of shoulder dystocia cases (risk ratio, 0.13; 95% confidence interval, 0.04-0.49). In contrast, the study that reported on persistent neonatal brachial plexus palsy at 12 months for all deliveries noted that it did not change significantly, namely from 0.3 to 0.2 per 1000 births (risk ratio, 0.77; 95% confidence interval, 0.31-1.90). Following the implementation of shoulder dystocia interventional exercises, the diagnosis of shoulder dystocia increased significantly from 1.2% to 1.7% of vaginal deliveries (risk ratio, 1.39; 95% Cr, 1.19-1.65; probability of increase 100%). Compared with the preimplementation period, the cesarean delivery rate increased postimplementation from 21.2% to 25.9% (risk ratio, 1.22; 95% Cr, 0.93-1.59; probability of increase 93%). We created an online tool (https://ccrebm-bell.shinyapps.io/sdmeta/) that permits calculation of the absolute risk reduction and absolute risk increase attributable to the intervention vis-à-vis the incidence of shoulder dystocia, neonatal brachial plexus palsy, and cesarean deliveries.

Conclusion: Introduction of shoulder dystocia interventional exercises decreased the rate of neonatal brachial plexus palsy per shoulder dystocia case; the data on persistence of neonatal brachial plexus palsy beyond 12 months is limited and contradictory. Implementation of the interventions was associated with an increase in the diagnosis of shoulder dystocia and rate of cesarean deliveries.
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November 2021

Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial.

Am J Obstet Gynecol 2021 07 15;225(1):87.e1-87.e10. Epub 2021 Apr 15.

Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.

Background: Insulin detemir, being used increasingly during pregnancy, may have pharmacologic benefits compared with neutral protamine Hagedorn.

Objective: We evaluated the probability that compared with treatment with neutral protamine Hagedorn, treatment with insulin detemir reduces the risk for adverse neonatal outcome among individuals with type 2 or overt type 2 diabetes mellitus (gestational diabetes mellitus diagnosed at <20 weeks' gestation).

Study Design: We performed a multiclinic randomized controlled trial (September 2018 to January 2020), which included women with singleton gestation with type 2 or overt type 2 diabetes mellitus who sought obstetrical care at ≤21 weeks' gestation. Participants were randomized to receive either insulin detemir or neutral protamine Hagedorn by a clinic-stratified scheme. The primary outcome was a composite of adverse neonatal outcomes, including shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need of at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia. The secondary neonatal outcomes included gestational age at delivery, small for gestational age, 5-minute Apgar score of <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay. The secondary maternal outcomes included hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications. We used the Bayesian statistics to estimate a sample size of 108 to have >75% probability of any reduction in the primary outcome, assuming 80% power and a hypothesized effect of 33% reduction with insulin detemir. All analyses were intent to treat under a Bayesian framework with neutral priors (a priori assumed a 50:50 likelihood of either intervention being better; National Clinical Trial identifier 03620890).

Results: There were 108 women randomized in this trial (57 in insulin detemir and 51 in neutral protamine Hagedorn), and 103 women were available for analysis of the primary outcome (n=5 for pregnancy loss before 24 weeks' gestation). Bayesian analysis indicated an 87% posterior probability of reduced primary outcome with insulin detemir compared with neutral protamine Hagedorn (posterior adjusted relative risk, 0.88; 95% credible interval, 0.61-1.12). Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with the use of insulin detemir vs neutral protamine Hagedorn: for example, maternal hypoglycemic events (97% probability of benefit; posterior adjusted relative risk, 0.59; 95% credible interval, 0.29-1.08) and hypertensive disorders (88% probability of benefit; posterior adjusted relative risk, 0.81; 95% credible interval, 0.54-1.16).

Conclusion: In our comparative effectiveness trial involving individuals with type 2 or overt type 2 diabetes mellitus, use of insulin detemir resulted in lower rates of adverse neonatal and maternal outcomes compared with neutral protamine Hagedorn.
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July 2021

Differences in obstetrical care and outcomes associated with the proportion of the obstetrician's shift completed.

Am J Obstet Gynecol 2021 10 2;225(4):430.e1-430.e11. Epub 2021 Apr 2.

Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR.

Background: Understanding and improving obstetrical quality and safety is an important goal of professional societies, and many interventions such as checklists, safety bundles, educational interventions, or other culture changes have been implemented to improve the quality of care provided to obstetrical patients. Although many factors contribute to delivery decisions, a reduced workload has addressed how provider issues such as fatigue or behaviors surrounding impending shift changes may influence the delivery mode and outcomes.

Objective: The objective was to assess whether intrapartum obstetrical interventions and adverse outcomes differ based on the temporal proximity of the delivery to the attending's shift change.

Study Design: This was a secondary analysis from a multicenter obstetrical cohort in which all patients with cephalic, singleton gestations who attempted vaginal birth were eligible for inclusion. The primary exposure used to quantify the relationship between the proximity of the provider to their shift change and a delivery intervention was the ratio of time from the most recent attending shift change to vaginal delivery or decision for cesarean delivery to the total length of the shift. Ratios were used to represent the proportion of time completed in the shift by normalizing for varying shift lengths. A sensitivity analysis restricted to patients who were delivered by physicians working 12-hour shifts was performed. Outcomes chosen included cesarean delivery, episiotomy, third- or fourth-degree perineal laceration, 5-minute Apgar score of <4, and neonatal intensive care unit admission. Chi-squared tests were used to evaluate outcomes based on the proportion of the attending's shift completed. Adjusted and unadjusted logistic models fitting a cubic spline (when indicated) were used to determine whether the frequency of outcomes throughout the shift occurred in a statistically significant, nonlinear pattern RESULTS: Of the 82,851 patients eligible for inclusion, 47,262 (57%) had ratio data available and constituted the analyzable sample. Deliveries were evenly distributed throughout shifts, with 50.6% taking place in the first half of shifts. There were no statistically significant differences in the frequency of cesarean delivery, episiotomy, third- or fourth-degree perineal lacerations, or 5-minute Apgar scores of <4 based on the proportion of the shift completed. The findings were unchanged when evaluated with a cubic spline in unadjusted and adjusted logistic models. Sensitivity analyses performed on the 22.2% of patients who were delivered by a physician completing a 12-hour shift showed similar findings. There was a small increase in the frequency of neonatal intensive care unit admissions with a greater proportion of the shift completed (adjusted P=.009), but the findings did not persist in the sensitivity analysis.

Conclusion: Clinically significant differences in obstetrical interventions and outcomes do not seem to exist based on the temporal proximity to the attending physician's shift change. Future work should attempt to directly study unit culture and provider fatigue to further investigate opportunities to improve obstetrical quality of care, and additional studies are needed to corroborate these findings in community settings.
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http://dx.doi.org/10.1016/j.ajog.2021.03.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8486887PMC
October 2021

Shoulder dystocia and composite adverse outcomes for the maternal-neonatal dyad.

Am J Obstet Gynecol MFM 2021 07 20;3(4):100359. Epub 2021 Mar 20.

Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Drs Mendez-Figueroa, Blackwell, and Chauhan). Electronic address:

Background: Although the neonatal morbidity associated with shoulder dystocia are well known, the maternal morbidity caused by this obstetrical emergency is infrequently reported.

Objective: This study aimed to assess the composite adverse maternal and neonatal outcomes among vaginal deliveries (at 34 weeks or later) with and without shoulder dystocia.

Study Design: This is a secondary analysis of the Consortium of Safe Labor, an observational obstetrical cohort of all vaginal deliveries occurring at 19 hospitals (from 2002-2008) and for which data on the occurrence of shoulder dystocia were available. The composite adverse maternal outcome included third- or fourth-degree perineal laceration, postpartum hemorrhage (>500 cc blood loss for a vaginal delivery and >1000 cc blood loss for cesarean delivery), blood transfusion, chorioamnionitis, endometritis, thromboembolism, admission to intensive care unit, or maternal death. The composite adverse neonatal outcome included an Apgar score of <7 at 5 minutes, a birth injury, neonatal seizure, hypoxic ischemic encephalopathy, or neonatal death. A multivariable Poisson regression was used to estimate the adjusted relative risks with 95% confidence intervals. The area under the receiver operating characteristic curve was constructed to determine if clinical factors would identify shoulder dystocia.

Results: Of the 228,438 women in the overall cohort, 130,008 (59.6%) met the inclusion criteria, and among them, shoulder dystocia was documented in 2159 (1.7%) cases. The rate of composite maternal morbidity was significantly higher among deliveries with shoulder dystocia (14.7%) than without (8.6%; adjusted relative risk, 1.71; 95% confidence interval, 1.64-2.01). The most common maternal morbidity with shoulder dystocia was a third- or fourth-degree laceration (adjusted relative risk, 2.82; 95% confidence interval, 2.39-3.31). The risk of composite neonatal morbidity with shoulder dystocia (12.2%) was also significantly higher than without shoulder dystocia (2.4%) (adjusted relative risk, 5.18; 95% confidence interval, 4.60-5.84). The most common neonatal morbidity was birth injury (adjusted relative risk, 5.39; 95% confidence interval, 4.71-6.17). The area under the curve for maternal characteristics to identify shoulder dystocia was 0.66 and it was 0.67 for intrapartum factors.

Conclusion: Although shoulder dystocia is unpredictable, the associated morbidity affects both mothers and newborns. The focus should be on concurrently averting the composite morbidity for the maternal-neonatal dyad with shoulder dystocia.
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July 2021

Neonatal brachial plexus palsy: associated birth injury outcomes, hospital length of stay and costs.

J Matern Fetal Neonatal Med 2021 Feb 25:1-9. Epub 2021 Feb 25.

Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.

Objective: To compare the birth injury outcomes and hospital length of stay and costs among newborns delivered at 34-42 weeks with neonatal brachial plexus palsy (NBPP) versus those without.

Study Design: We conducted a retrospective, cross-sectional study using data from the National Inpatient Sample to identify all newborns hospitalizations that occurred in the U.S. between 2016 and 2017. We included non-anomalous single liveborn delivered in-hospital at 34-42 weeks. The newborns with NBPP were identified by International Classification of Diseases, 10th Revision, Clinical Modification codes. Birth injury outcomes, and hospital length of stay and hospital costs were examined. A multivariable Poisson regression model with robust error variance was used to examine the association between NBPP and birth injury outcomes. A multivariable generalized linear regression model was used to examine the association between NBPP and hospital length of stay and hospital costs.

Results: Of 7,019,722 non-anomalous single liveborn delivered at 34-42 weeks in the U.S. from 2016 to 2017, the rate of NBPP ( = 6695) was 0.95 per 1000 newborn hospitalizations. After multivariable regression adjustment, compared to newborns without NBPP, the risk of the composite birth injury outcome was 2.91 (95% CI 2.61-3.25) times higher in those with NBPP. Similar results of an increased risk among newborns with NBPP were observed in all individual birth injury outcomes. Compared to newborns without NBPP, after adjustment, the hospital length of stay was 1.48 (95% IC 1.38-1.59) times higher and the hospital costs were 2.21 (95% CI 1.97-2.48) times higher in those with NBPP.

Conclusions: Among newborns delivered at 34-42 weeks, the risk of associated birth injuries, hospital length of stay and costs, were significantly higher in newborns with NBPP than those without.
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February 2021

Cervical length distribution and other sonographic ancillary findings of singleton nulliparous patients at midgestation.

Am J Obstet Gynecol 2021 08 20;225(2):181.e1-181.e11. Epub 2021 Feb 20.

Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA.

Background: Short cervix at midgestation, the presence of intraamniotic debris, and cervical funneling are risk factors for preterm birth; however, cervical length measurements and cutoffs are not well documented among pregnant patients of different gestational ages and self-reported races and ethnicities.

Objective: This study aimed to describe the distribution of cervical length and frequency of funneling and debris at midgestation in nulliparous women by gestational age and race/ethnicity.

Study Design: This secondary analysis of screening data from a multicenter treatment trial of singleton nulliparous patients with short cervix was conducted at 14 geographically distributed, university-affiliated medical centers in the United States. Singleton nulliparous patients with no known risk factors for preterm birth were screened for trial participation and asked to undergo a transvaginal ultrasound to measure cervical length by a certified sonographer. The distribution of cervical length and the frequency of funneling and debris were assessed for each gestational age week (16-22 weeks) and stratified by self-reported race and ethnicity, which for this study were categorized as White, Black, Hispanic, and other. Patients enrolled in the randomized trial were excluded from this analysis.

Results: A total of 12,407 nulliparous patients were included in this analysis. The racial or ethnic distribution of the study participants was as follows: White, 41.6%; Black, 29.6%; Hispanic, 24.2%; and others, 4.6%. The 10th percentile cervical length for the entire cohort was 31.1 mm and, when stratified by race and ethnicity, 31.9 mm for White, 30.2 mm for Black, 31.4 mm for Hispanic, and 31.2 mm for patients of other race and ethnicity (P<.001). At each gestational age, the cervical length corresponding to the tenth percentile was shorter in Black patients. The 25 mm value commonly used to define a short cervix and thought to represent the 10th percentile ranged from 1.3% to 5.4% across gestational age weeks and 1.0% to 3.8% across race and ethnicity groups. Black patients had the highest rate of funneling (2.6%), whereas Hispanic and Black patients had higher rates of intraamniotic debris than White and other patients (P<.001).

Conclusion: Black patients had shorter cervical length and higher rates of debris and funneling than White patients. The racial and ethnic disparities in sonographic midtrimester cervical findings may provide insight into the racial disparity in preterm birth rates in the United States.
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http://dx.doi.org/10.1016/j.ajog.2021.02.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8328864PMC
August 2021

Pregnancy Outcomes Among Individuals Who Enrolled Compared With Declined Enrollment in A Randomized Trial of Induction Versus Expectant Management (ARRIVE).

Obstet Gynecol 2021 03;137(3):493-496

Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, the University of Texas Health Science Center at Houston, and the Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.

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http://dx.doi.org/10.1097/AOG.0000000000004286DOI Listing
March 2021

Predictors of neonatal brachial plexus palsy subsequent to resolution of shoulder dystocia.

J Matern Fetal Neonatal Med 2021 Feb 4:1-7. Epub 2021 Feb 4.

Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.

Objective: The objective was to ascertain factors among deliveries complicated by shoulder dystocia (SD) and neonatal brachial plexus palsy (NBPP).

Methods: At 11 hospitals, deliveries complicated by SD were identified. The inclusion criteria were vaginal delivery of non-anomalous, singleton at 34-42 weeks. Adjusted odds ratios (aOR) with 95% confidence intervals (CI) were calculated. Receiver operating characteristic (ROC) curves were created to evaluate the predictive value of the models for NBPP.

Results: Of the 62,939 individuals who delivered vaginally, 1,134 (1.8%) had SD and met other inclusion criteria. Among the analytic cohort, 74 (6.5%) had NBPP. The factor known before delivery which was associated with NBPP was diabetes (aOR = 3.87; 95% CI = 2.13-7.01). After delivery, the three factors associated with NBPP were: (1) birthweight of at least 4000 g (aOR = 1.83; 95% CI = 1.05-3.20); (2) calling for help during the SD (aOR = 4.09, 95% CI = 2.29-7.30), and (3) the duration of SD ≥120 sec (aOR = 2.47, 95% CI = 1.30-4.69). The AUC under the ROC curve for these independent factors was 0.79 (95% CI = 0.77 - 0.82).

Conclusions: Few factors were identified that were associated with NBPP after SD, but they could not reliably predict which neonates will experience the complication.
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http://dx.doi.org/10.1080/14767058.2021.1882982DOI Listing
February 2021
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