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Background The Ideal Life Blood Pressure Manager measures blood pressure (BP) and automatically transmits results to the patient’s medical record independent of internet access, but has not been validated. Our objective was to conduct a validation study of the Ideal Life BP Manager in pregnant women using a validation protocol. Methods Pregnant participants were enrolled into three subgroups per the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization protocol: normotensive (systolic blood pressure (SBP) < 140 and diastolic blood pressure (DBP) < 90), hypertensive without proteinuria (SBP ≥ 140 or DBP ≥ 90), and preeclampsia (SBP ≥ 140 or DBP ≥ 90 with proteinuria). Two trained research staff used a mercury sphygmomanometer to validate the device, alternating sphygmomanometer, and device readings for a total of 9 measurements. Results Among 51 participants, the mean SBP and DBP differences and standard deviations between the device and the mean staff measurements for all participants were 1.7 ± 7.1 and 1.5 ± 7.0 mm Hg, respectively. The standard deviations of the individual participant’s paired device and mean staff SBP and DBP measurements were 6.0 and 6.4 mm Hg, respectively. The device was more likely to overestimate rather than underestimate BP (SBP: mean difference = 1.67, 95% CI [−12.15 to 15.49]; DBP: mean difference = 1.51, 95% CI [−12.26 to 15.28]). Most paired readings had a difference of less than 10 mm Hg across averaged paired readings. Conclusion The Ideal Life BP Manager met internationally recognized validity criteria in this sample of pregnant women.

OBJECTIVE: To estimate the incidence of severe chronic hypertension (cHTN) within 5–7 years after a pregnancy complicated by mild cHTN. METHODS: This was a retrospective cohort study of women with mild cHTN during an index pregnancy between 2012 and 2014. Women were included if they received prenatal care at a single academic center and had mild cHTN during their pregnancy. Women with severe cHTN, type 1 diabetes, systemic lupus erythematosus, cardiomyopathy, proteinuria, or creatinine level greater than 1.1 mg/dL before 23 weeks of gestation at baseline were excluded. The primary outcome was a composite of severe cHTN (defined as new-onset of two or more severe blood pressures) or new-onset cardiovascular disease complications more than 12 weeks after the index delivery. RESULTS: A total of 647 women with mild cHTN met inclusion criteria. Of these, 236 (36.5%, 95% CI 32.8–40.2%) women experienced the primary composite outcome of severe cHTN within 5–7 years of the index pregnancy. Black women progressed more rapidly than White women (adjusted hazard ratio [aHR] 1.99, 95% CI 1.43–2.76). Smoking tobacco was also associated with more rapid progression to severe cHTN (aHR 1.47, 95% CI 1.13–1.90). CONCLUSION: In this cohort, one in three women with mild cHTN in an index pregnancy progressed to severe cHTN within 5–7 years. Prospective studies to validate this finding are needed.

Objectives: To identify 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 ≥390/7 weeks gestation delivered at a single center in 2013. Exclusion criteria were elective induction, cesarean delivery or presence of a medical indication for delivery at 39weeks, more than one prior cesarean delivery, 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 mode of delivery and other secondary outcomes between patients who spontaneous labored 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 BMI, parity and substance use were identified as the most predictive factors. Overall, the model did not predict spontaneous labor(AUC 0.65, 95% 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(OR 0.33, 95% CI 0.21-0.53) and NICU admission(OR 0.38, 95% CI 0.15-0.94). Other perinatal outcomes were similar between groups. Conclusions : Maternal characteristics did not predict spontaneous labor onset ≥39 weeks’ gestation with high accuracy. Patients should be counseled on challenges of labor prediction regardless of parity and cervical examination, outcomes if spontaneous labor does not occur and benefits of elective labor induction discussed.

Objective: To compare the risks of adverse perinatal outcomes by BMI categories in healthy pregnant individuals delivered by term elective repeat cesarean (ERCD) in order to describe an optimal timing of delivery in otherwise healthy patients at the highest-risk BMI threshold. Study Design: A secondary analysis of a prospective cohort of pregnant individuals undergoing ERCD at 19 centers in the Maternal Fetal Medicine Units Network from 1999-2002. Non-anomalous singletons, undergoing pre-labor ERCD at term were included. The primary outcome was composite neonatal morbidity; secondary outcomes included composite maternal morbidity and individual components of the composites. Patients were stratified by BMI classes and in order to identify a BMI threshold for which morbidity was highest. Outcomes were then examined by completed week’s gestation, between BMI classes. Multivariable logistic regression was used to calculate adjusted ORs and 95% CIs. Results: 12,755 patients were included in analysis. Patient’s with BMI ≥40 had highest rates of newborn sepsis, neonatal ICU admissions, and wound complications. While a weight-related response was observed between BMI class and neonatal composite morbidity (p

Objective: 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: Retrospective cohort study of patients ≥23 weeks' gestation delivering at a single tertiary care referral center from 2013-2018. Demographic characteristics, mode of delivery, and main indication for cesarean delivery were ascertained by individual chart review. Cesarean delivery indications (mutually exclusive) were: repeat cesarean delivery, non-reassuring 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, 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

Background Early coronavirus disease 2019 (COVID-19) vaccine trials excluded pregnant women, resulting in limited data about immunogenicity and maternal–fetal antibody transfer, particularly by gestational timing of vaccination. Methods In this multicenter observational immunogenicity study, pregnant and nonpregnant women receiving COVID-19 vaccines were prospectively enrolled. Participants had sera collected before vaccination, at 14–28 days after each vaccine dose, at delivery (umbilical cord and peripheral), and from their infants at 3 and 6 months. Geometric mean titers (GMTs) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ID50 neutralizing antibody (nAb) against D614G-like viruses were compared by participant characteristics. Results Overall, 23 nonpregnant and 85 pregnant participants (trimester of first vaccine dose: 10 first, 47 second, 28 third) were enrolled. Ninety-three percent (76/82 with blood samples) of pregnant participants had detectable SARS-CoV-2 nAb after 2 vaccine doses, but GMTs (95% confidence intervals) were lower in pregnant participants than nonpregnant participants (1722 [1136–2612] vs 4419 [2012–9703]; P = .04). By 3 and 6 months, 28% and 74% of infants, respectively, of vaccinated participants had no detectable nAb to D614G-like viruses. Among the 71 pregnant participants without detectable nAb before vaccination, cord blood GMTs at delivery were 5-fold higher among participants vaccinated during the third versus first trimester, and cord blood nAb titers appeared inversely correlated with weeks since first vaccine dose (R2 = 0.06, P = .06). Conclusions Though most pregnant women develop nAb after 2 doses of mRNA COVID-19 vaccines, this analysis suggests that infant protection from maternal vaccination varies by gestational timing of vaccination and wanes. Additional prevention strategies such as caregiver vaccination may warrant consideration to optimize infant protection.

We examined associations between mild or asymptomatic prenatal SARS-CoV-2 infection and preterm live birth in a prospective cohort study. During August 2020–October 2021, pregnant persons were followed with systematic surveillance for RT-PCR or serologically-confirmed SARS-CoV-2 infection until pregnancy end. The association between prenatal SARS-CoV-2 infection and preterm birth was assessed using Cox proportional-hazards regression. Among 954 pregnant persons with a live birth, 185 (19%) had prenatal SARS-CoV-2 infection and 123 (13%) had preterm birth. The adjusted hazard ratio for the association between SARS-CoV-2 infection and preterm birth was 1.28 (95% confidence interval 0.82-1.99, p=0.28), although results did not reach statistical significance.

The aim of the study was to investigate the differences in reliable contraceptive use between black women and white women with maternal cardiac disease. The study comprised a retrospective cohort of women with maternal cardiac disease managed by the University of Alabama at Birmingham (UAB) Comprehensive Pregnancy and Heart Program (CPHP). Women were included if they had attended one or more prenatal visits at the UAB CPHP and delivered at the UAB hospital between March 2015 and June 2019. The primary outcome was reliable contraceptive use within 2 months postpartum, defined by receipt of long-acting reversible contraception (i.e., an intrauterine contraceptive device or an etonogestrel implant) or female sterilisation. All outcomes were compared based on self-reported race. One hundred and forty-nine women met the inclusion criteria. Black women (n = 63) were more likely than white women (n = 86) to use reliable contraception (65% vs 43%; p = 0.008). Black women were less likely than white women to be undecided or decline contraception at the time of admission (13% vs 27%; p = 0.037). There was no difference in reliable contraceptive use between black women (n = 20, 63%) and white women (n = 23, 72%) with modified World Health Organisation (WHO) class III/IV lesions (p = 0.42). Black women with maternal cardiac disease were more likely than white women to receive reliable contraception. Interventions to prevent unintended pregnancy in women with maternal cardiac disease should focus on improving reliable contraceptive use, especially for women with modified WHO class III/IV lesions.

Background: Rates of severe maternal mor­bidity and maternal mortality (SMM/MM) in the United States are rising. Disparities in SMM/MM persist by race, ethnicity and geography, and could partially be attributed to social determinants of health.Purpose: Utilizing data from the largest, statewide referral hospital in Alabama, we investigated the relationship between residence in disadvantaged neighborhoods and SMM/MM.Methods: Data on all pregnancies between 2010 and 2020 were included; SMM/MM cases were identified using CDC definitions. Area deprivation index (ADI) available at the census-block group was geographically linked to individual records and categorized using quintile cutoffs; higher ADI score indi­cated higher socioeconomic disadvantage. Generalized estimating equation models were used to adjust for spatial autocorrela­tion and ORs were computed to evaluate the relationship between ADI and SMM/ MM, adjusted for covariates including age, race, insurance, residence in medically underserved areas/population (MUAP), and urban/rural residence.Results: Overall, 32,909 live-birth deliveries were identified, with a prevalence of 9.8% deliveries with SMM/MM with blood trans­fusion and 5.3% without blood transfusion, respectively. Increased levels of ADI were associated with increased odds of SMM/ MM. Compared to women in the lowest quintile, the adjusted OR for SMM/MM among women in highest quintile was 1.78 (95%CI, 1.22-2.59, P=.0027); increas­ing age, non-Hispanic Black, government insurance and residence in MUAP were also significantly associated with increased odds of SMM/MM.Conclusion: Our results suggest that resi­dence within disadvantaged neighborhoods may contribute to SMM/MM even after adjusting for patient-level factors. Measures such as ADI can help identify the most vulnerable populations and provide points to intervene.Ethn Dis.2022;32(4):293-304; doi:10.18865/ed.32.4.293

Maternal and newborn infections are a major contributor to mortality and morbidity globally. Lost-cost, effective and safe interventions are needed to address these. Based on promising findings, azithromycin has been identified as potentially effective antibiotic to reduce maternal and newborn infections in low- and middle-income countries (LMICs). However, robust randomized clinical trials in a range of settings are needed to confirm these findings as well as to understand the implications for antimicrobial resistance. To better understand the impact of azithromycin on maternal and newborn health, at least three clinical trials are being conducted to evaluate azithromycin in LMICs. We describe these trials, the importance of harmonizing study measures and the potential public health impact of azithromycin in LMICs.

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 p = 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

Background: Respiratory symptoms and asthma in children pose a significant clinical and public health burden. Our aim was to examine exposures to environmental air pollution in relation to asthma and related symptoms in a multi-racial cohort of children. Methods: We conducted a cross-sectional analysis evaluating the association between reported neighborhood traffic (a proxy for traffic-related air pollution) and asthma among 855 children aged 4 to 8 years old who participated in the Environmental Influences on Child Health Outcomes (ECHO) cohort. The primary outcome, asthma/asthma like symptoms (defined as current and/or past physician diagnosed asthma, past wheezing, or nighttime cough or wheezing in the past 12 months), was assessed by parental report via questionnaire. The relationship between the primary exposure and asthma/asthma like symptoms was examined using logistic regression. Results: The prevalence of asthma/asthma like symptoms was 23%. Fifteen percent of parents responded “Agree” or “Strongly Agree” to the question, “There is so much traffic along the streets that it makes it difficult or dangerous to walk with my child in my neighborhood” (n=129/855). Children whose parents had affirmed significant neighborhood traffic had a higher odds of having asthma/asthma like symptoms than children without significant neighborhood traffic [adjusted OR=1.78 (95% CI: 1.10, 2.88)] after controlling for child’s race-ethnicity, age, sex, maternal education level, family history of asthma, presence of play equipment in the home environment, public parks in the neighborhood and obesity. Other factors significantly associated with asthma/asthma like symptoms were: non-Hispanic Black and Hispanic race/ethnicity [OR=2.53 (95% CI: 1.43, 4.50)] and [OR=2.25 (95% CI: 1.28, 3.94), respectively, vs. non-Hispanic White referent], play equipment in the home environment or backyard [OR=1.60 (95% CI: 1.09, 2.35)], obese status [OR=2.54 (95% CI: 1.55, 4.17)], male sex [OR=1.53 (1.06, 2.22)] and family history of asthma [OR=3.19 (2.20, 4.64)]. Conclusions: Reported neighborhood traffic, non-Hispanic Black and Hispanic race/ethnicity, male sex, play equipment within the home environment, obesity, and family history of asthma were associated with greater odds for asthma/asthma like symptoms. Further characterization of neighborhood traffic patterns is needed, since many children live near this source of environmental air pollution and significant racial/ethnic disparities exist.

The objective of the study was to describe characteristics and outcomes of a review of multisite perinatal studies by individual institutional review boards (IRBs) and identify barriers and opportunities for streamlined IRB review.We compared the review of 5 collaborative protocols by individual IRBs at National Perinatal Research Consortium centers from 2007 through 2012. Three randomized trials, 1 observational study, and 1 follow-up study of a trial were selected. IRB logs and communications were reviewed and abstracted by trained team members.Seven or 8 IRBs reviewed each protocol. Monthly IRB meeting frequency varied from 1 to 6. Full board review was required by all IRBs for the primary trials but not by all for the observational protocols. The overall duration from submission to approval (P = .024) and number of stipulations (P = .007) differed across protocols but not across IRBs. However, times from submission-to-IRB review (P = .011) and IRB review-to-initial letter (P.007) differed across sites. Both overall submission-to-approval and initial review-to-approval times increased with the increasing number of IRB review stipulations (both values P.001). Significant delays (60 days) were few and not consistent across IRBs or protocols. Most stipulations were stylistic or editorial modifications rather than regulatory requests. All protocols were approved without changes, and no more than 1 IRB meeting was needed at each site.Findings confirm unnecessary duplication and variability and some similarities in IRB review processes and outcomes for multisite perinatal studies. This may help guide initiatives to streamline IRB review and reduce research delays and burdens.