Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial.

Importance: Insulin is recommended for pregnant persons with preexisting type 2 diabetes or diabetes diagnosed early in pregnancy. The addition of metformin to insulin may improve neonatal outcomes. Objective: To estimate the effect of metformin added to insulin for preexisting type 2 or diabetes diagnosed early in pregnancy on a composite adverse neonatal outcome. Design, Setting, and Participants: This randomized clinical trial in 17 US centers enrolled pregnant adults aged 18 to 45 years with preexisting type 2 diabetes or diabetes diagnosed prior to 23 weeks' gestation between April 2019 and November 2021. Each participant was treated with insulin and was assigned to add either metformin or placebo. Follow-up was completed in May 2022. Intervention: Metformin 1000 mg or placebo orally twice per day from enrollment (11 weeks -<23 weeks) through delivery. Main Outcome and Measures: The primary outcome was a composite of neonatal complications including perinatal death, preterm birth, large or small for gestational age, and hyperbilirubinemia requiring phototherapy. Prespecified secondary outcomes included maternal hypoglycemia and neonatal fat mass at birth, and prespecified subgroup analyses by maternal body mass index less than 30 vs 30 or greater and those with preexisting vs diabetes early in pregnancy. Results: Of the 831 participants randomized, 794 took at least 1 dose of the study agent and were included in the primary analysis (397 in the placebo group and 397 in the metformin group). Participants' mean (SD) age was 32.9 (5.6) years; 234 (29%) were Black, and 412 (52%) were Hispanic. The composite adverse neonatal outcome occurred in 280 (71%) of the metformin group and in 292 (74%) of the placebo group (adjusted odds ratio, 0.86 [95% CI 0.63-1.19]). The most commonly occurring events in the primary outcome in both groups were preterm birth, neonatal hypoglycemia, and delivery of a large-for-gestational-age infant. The study was halted at 75% accrual for futility in detecting a significant difference in the primary outcome. Prespecified secondary outcomes and subgroup analyses were similar between groups. Of individual components of the composite adverse neonatal outcome, metformin-exposed neonates had lower odds to be large for gestational age (adjusted odds ratio, 0.63 [95% CI, 0.46-0.86]) when compared with the placebo group. Conclusions and Relevance: Using metformin plus insulin to treat preexisting type 2 or gestational diabetes diagnosed early in pregnancy did not reduce a composite neonatal adverse outcome. The effect of reduction in odds of a large-for-gestational-age infant observed after adding metformin to insulin warrants further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02932475.

The Association of Nutrition and Exercise Behaviors of Women with Diabetes in Pregnancy with Infant Breastfeeding Practices.

Background: Although breastfeeding confers significant benefits to infants, women with diabetes in pregnancy experience unique nutrition and health challenges, which may influence infant feeding practice. This study aimed to determine the association between nutrition and exercise behaviors of women with diabetes in pregnancy and breastfeeding at birth and 6 months. Methods: A secondary data analysis of a longitudinal study on maternal pregestational diabetes mellitus (DM) and gestational diabetes (GDM) and infant development was conducted. Women self-reported engaging in nutrition behaviors, such as using meal plans, and exercise health behaviors. Primary outcomes were exclusive breastfeeding at birth and any breastfeeding at 6 months. Logistic regression models adjusted for significant maternal-infant covariates. Results: Of n = 48 women with diabetes in pregnancy, 94% had GDM and 6% had pregestational type 1 or type 2 DM. Forty percent of women exclusively breastfed at birth and 68% partially or exclusively breastfed at 6 months (of n = 34 with complete 6-month data). Women who cooked their own meals had two times greater adjusted odds of exclusive breastfeeding at birth (adjusted odds ratio [AOR] = 1.94, 95% confidence interval [CI] = 1.12-5.11), and women who exercised during pregnancy had seven times greater adjusted odds of any breastfeeding at 6 months (AOR = 7.2, 95% CI = 1.10-42.8). Conclusion: Nutrition and exercise behaviors were associated with exclusive breastfeeding at birth and any breastfeeding at 6 months. Health behaviors to effectively manage diabetes during pregnancy may inform efforts to improve breastfeeding initiation and duration, and future studies in a larger sample are needed.

Neonatal Hypoglycemia following Late Preterm Antenatal Corticosteroid Administration in Individuals with Diabetes in Pregnancy.

OBJECTIVE: Antenatal corticosteroid (ACS) administration is standard practice for pregnant individuals delivering in the late preterm period, though no guidelines are in place for those with diabetes. This study aims to characterize the prevalence of neonatal hypoglycemia after ACS administration in pregnant individuals with diabetes delivering in the late preterm period. STUDY DESIGN: This is a retrospective, single-center, case-control study of individuals with diabetes who delivered between 340/7 and 366/7 weeks' gestation at a large academic medical center from 2016 to 2021. A total of 169 individuals were included in the analysis; 87 received corticosteroids and 82 did not. The proportion of neonates with hypoglycemia, neonatal intensive care unit (NICU) admission, respiratory distress syndrome, and hyperbilirubinemia were compared between parents who received ACSs versus those who did not. RESULTS: The prevalence of neonatal hypoglycemia (40.2 vs. 23.2%, p = 0.027), requiring treatment (40.3 vs. 22.4%, p = 0.041), and hyperbilirubinemia (35.6 vs 18.5%, p = 0.018) was greater for neonates born to individuals with diabetes who received late preterm ACSs compared with those who did not. There was no difference in NICU admission and respiratory distress between the groups. These results remained unchanged after controlling for confounders including gestational age at delivery and birth weight. CONCLUSION: This study demonstrates that late preterm corticosteroid administration to pregnant individuals with diabetes increases the risk for neonatal hypoglycemia without changing the rates of respiratory morbidity. KEY POINTS: · Late preterm ACS in diabetic patients resulted in higher rates of neonatal hypoglycemia.. · There are no differences in rates of respiratory distress syndrome and transient tachypnea of the newborn between the ACS group and control group.. · There was no noted difference in rate of NICU admission and length of stay between the two groups..

Assessment of Neurodevelopment in Infants With and Without Exposure to Asymptomatic or Mild Maternal SARS-CoV-2 Infection During Pregnancy.

Importance: Associations between prenatal SARS-CoV-2 exposure and neurodevelopmental outcomes have substantial public health relevance. A previous study found no association between prenatal SARS-CoV-2 infection and parent-reported infant neurodevelopmental outcomes, but standardized observational assessments are needed to confirm this finding. Objective: To assess whether mild or asymptomatic maternal SARS-CoV-2 infection vs no infection during pregnancy is associated with infant neurodevelopmental differences at ages 5 to 11 months. Design, Setting, and Participants: This cohort study included infants of mothers from a single-site prospective cross-sectional study (COVID-19 Mother Baby Outcomes [COMBO] Initiative) of mother-infant dyads and a multisite prospective cohort study (Epidemiology of Severe Acute Respiratory Syndrome Coronavirus 2 in Pregnancy and Infancy [ESPI]) of pregnant individuals. A subset of ESPI participants was subsequently enrolled in the ESPI COMBO substudy. Participants in the ongoing COMBO study were enrolled beginning on May 26, 2020; participants in the ESPI study were enrolled from May 7 to November 3, 2021; and participants in the ESPI COMBO substudy were enrolled from August 2020 to March 2021. For the current analysis, infant neurodevelopment was assessed between March 2021 and June 2022. A total of 407 infants born to 403 mothers were enrolled (204 from Columbia University Irving Medical Center in New York, New York; 167 from the University of Utah in Salt Lake City; and 36 from the University of Alabama in Birmingham). Mothers of unexposed infants were approached for participation based on similar infant gestational age at birth, date of birth, sex, and mode of delivery to exposed infants. Exposures: Maternal symptomatic or asymptomatic SARS-CoV-2 infection. Main Outcomes and Measures: Infant neurodevelopment was assessed using the Developmental Assessment of Young Children, second edition (DAYC-2), adapted for telehealth assessment. The primary outcome was age-adjusted standard scores on 5 DAYC-2 subdomains: cognitive, gross motor, fine motor, expressive language, and receptive language. Results: Among 403 mothers, the mean (SD) maternal age at delivery was 32.1 (5.4) years; most mothers were of White race (240 [59.6%]) and non-Hispanic ethnicity (253 [62.8%]). Among 407 infants, 367 (90.2%) were born full term and 212 (52.1%) were male. Overall, 258 infants (63.4%) had no documented prenatal exposure to SARS-CoV-2 infection, 112 (27.5%) had confirmed prenatal exposure, and 37 (9.1%) had exposure before pregnancy or at an indeterminate time. In adjusted models, maternal SARS-CoV-2 infection during pregnancy was not associated with differences in cognitive (ß = 0.31; 95% CI, -2.97 to 3.58), gross motor (ß = 0.82; 95% CI, -1.34 to 2.99), fine motor (ß = 0.36; 95% CI, -0.74 to 1.47), expressive language (ß = -1.00; 95% CI, -4.02 to 2.02), or receptive language (ß = 0.45; 95% CI, -2.15 to 3.04) DAYC-2 subdomain scores. Trimester of exposure and maternal symptom status were not associated with DAYC-2 subdomain scores. Conclusions and Relevance: In this study, results of a novel telehealth-adapted observational neurodevelopmental assessment extended a previous finding of no association between prenatal exposure to maternal SARS-CoV-2 infection and infant neurodevelopment. Given the widespread and continued high prevalence of COVID-19, these data offer information that may be helpful for pregnant individuals who experience asymptomatic or mild SARS-CoV-2 infections.

'We tend to prioritise others and forget ourselves': How women's caregiving responsibilities can facilitate or impede diabetes self-management.

AIM: The objective of the parent study was to examine attitudes and experiences regarding counselling about preconception care among Black and/or Latina women in the United States with type 2 diabetes (T2DM). Here, we present emergent findings from a secondary analysis of caregiving. METHODS: In this qualitative descriptive study, we used conventional content analysis to identify themes from semi-structured interviews with 32 Black and/or Latina women ages 18-40 who have T2DM in the United States recruited from online platforms and snowball sampling. RESULTS: Caregiving responsibilities both motivate and disrupt diabetes self-management behaviours. Caregiving largely meant taking care of children, but women also had responsibilities to adult family members and romantic partners. Women were motivated to manage their diabetes in order to prevent negative health effects on their children and to stay healthy so they could fulfil caregiving responsibilities. However, caregiving competed for time, energy and money with self-management. Struggling to balance caregiving and self-management caused stress that women felt was intrinsically unhealthy and undermined self-management. CONCLUSIONS: Young adult women with T2DM identified different ways that the roles and responsibilities in the family could affect their diabetes self-management. Providers and policymakers should develop health-promoting interventions that accommodate caregiving responsibilities.

Trends in delivery hospitalizations with pregestational and gestational diabetes mellitus and associated outcomes: 2000-2019.

BACKGROUND: Pregestational diabetes mellitus and its associated risks may be increasing in the obstetrical population. OBJECTIVE: This study aimed to characterize the trends in delivery hospitalizations with pregestational diabetes mellitus, the prevalence of chronic diabetes complications, and the risk for adverse outcomes. STUDY DESIGN: This repeated, cross-sectional study used the United States National Inpatient Sample to identify delivery hospitalizations with pregestational diabetes mellitus between 2000 and 2019. Trends in delivery hospitalizations with pregestational diabetes mellitus were assessed using joinpoint regression to determine the average annual percent change. Trends in chronic diabetes complications, including chronic kidney disease, neuropathy, peripheral vascular disease, and diabetic retinopathy, were also analyzed. The risk for adverse obstetrical outcomes was compared between patients with and those without pregestational diabetes mellitus using adjusted logistic regression models that were adjusted for demographic, clinical, and hospital characteristics with adjusted odds ratios with 95% confidence intervals as measures of association. RESULTS: Of 76.7 million delivery hospitalizations, 179,885 (0.23%) had type 1 diabetes mellitus, 430,544 (0.56%) had type 2 diabetes mellitus, and 99,327 (0.13%) had unspecified diabetes mellitus. From 2000 to 2019, the prevalence of diabetes mellitus increased from 1.8 to 7.3 per 1000 deliveries for type 2 diabetes mellitus (average annual percent change, 8.0%; 95% confidence interval, 6.9%-9.2%), from 1.5 to 3.2 per 1000 deliveries for unspecified diabetes mellitus (average annual percent change, 3.9%; 95% confidence interval, 1.4%-6.3%), and from 2.7 in 2000 to 2.8 per 1000 deliveries (average annual percent change, 0.2%; 95% confidence interval, -0.8% to 1.3%) for type 1 diabetes mellitus. The prevalence of chronic diabetes mellitus complications increased from 2.7% to 5.6% over the study period (average annual percent change, 5.9%; 95% confidence interval, 3.7%-8.0%). Pregestational diabetes mellitus was associated with severe maternal morbidity, cesarean delivery, hypertensive disorders of pregnancy, preterm birth, and shoulder dystocia. CONCLUSION: Pregestational diabetes mellitus increased over the study period, driven by a quadrupling in the prevalence of type 2 diabetes mellitus. Notably, the prevalence of chronic diabetes mellitus complications doubled concomitantly. Pregestational diabetes mellitus was associated with a range of adverse outcomes. These findings are further evidence that pregestational diabetes mellitus is an important contributor to maternal risk and that optimizing diabetes care in women of childbearing age will continue to be of major public health importance.

Telehealth for the Management of Diabetes in Pregnancy.

PURPOSE OF REVIEW: Telehealth initiatives are becoming ubiquitous in clinical practice and can be a useful tool in the management of diabetes in pregnancy. The purpose of this review is to summarize new techniques in telemedicine delivery and offer details on how to leverage telehealth in delivering care to pregnant women with diabetes. RECENT FINDINGS: Using mobile phone technology to collect glucose values in women with gestational diabetes has been found to be beneficial by increasing the amount of glucose data available for interpretation. Remote patient monitoring in non-pregnant people with type 2 diabetes has shown a modest improvement in glucose control. In pregnant women with diabetes, the use of remote patient monitoring does not appear to improve outcomes but can decrease in-office visits and lower healthcare costs. However, telehealth may not be the only solution to helping patients with diabetes in pregnancy who have difficulty engaging in their care. Telehealth affords improvements in convenience, efficiency, and frequency of communication with healthcare professionals, and the amount of data available to patients and providers alike, yielding the potential for better outcomes when telehealth modalities are adopted.

Association of Birth During the COVID-19 Pandemic With Neurodevelopmental Status at 6 Months in Infants With and Without In Utero Exposure to Maternal SARS-CoV-2 Infection.

Importance: Associations between in utero exposure to maternal SARS-CoV-2 infection and neurodevelopment are speculated, but currently unknown. Objective: To examine the associations between maternal SARS-CoV-2 infection during pregnancy, being born during the COVID-19 pandemic regardless of maternal SARS-CoV-2 status, and neurodevelopment at age 6 months. Design, Setting, and Participants: A cohort of infants exposed to maternal SARS-CoV-2 infection during pregnancy and unexposed controls was enrolled in the COVID-19 Mother Baby Outcomes Initiative at Columbia University Irving Medical Center in New York City. All women who delivered at Columbia University Irving Medical Center with a SARS-CoV-2 infection during pregnancy were approached. Women with unexposed infants were approached based on similar gestational age at birth, date of birth, sex, and mode of delivery. Neurodevelopment was assessed using the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) at age 6 months. A historical cohort of infants born before the pandemic who had completed the 6-month ASQ-3 were included in secondary analyses. Exposures: Maternal SARS-CoV-2 infection during pregnancy and birth during the COVID-19 pandemic. Main Outcomes and Measures: Outcomes were scores on the 5 ASQ-3 subdomains, with the hypothesis that maternal SARS-CoV-2 infection during pregnancy would be associated with decrements in social and motor development at age 6 months. Results: Of 1706 women approached, 596 enrolled; 385 women were invited to a 6-month assessment, of whom 272 (70.6%) completed the ASQ-3. Data were available for 255 infants enrolled in the COVID-19 Mother Baby Outcomes Initiative (114 in utero exposed, 141 unexposed to SARS-CoV-2; median maternal age at delivery, 32.0 [IQR, 19.0-45.0] years). Data were also available from a historical cohort of 62 infants born before the pandemic. In utero exposure to maternal SARS-CoV-2 infection was not associated with significant differences on any ASQ-3 subdomain, regardless of infection timing or severity. However, compared with the historical cohort, infants born during the pandemic had significantly lower scores on gross motor (mean difference, -5.63; 95% CI, -8.75 to -2.51; F1,267 = 12.63; P<.005), fine motor (mean difference, -6.61; 95% CI, -10.00 to -3.21; F1,267 = 14.71; P < .005), and personal-social (mean difference, -3.71; 95% CI, -6.61 to -0.82; F1,267 = 6.37; P<.05) subdomains in fully adjusted models. Conclusions and Relevance: In this study, birth during the pandemic, but not in utero exposure to maternal SARS-CoV-2 infection, was associated with differences in neurodevelopment at age 6 months. These early findings support the need for long-term monitoring of children born during the COVID-19 pandemic.

Obstetric Inpatient and Ultrasound Clinical Personnel Absences during the COVID-19 Pandemic in New York City.

OBJECTIVE: To review obstetric personnel absences at a hospital during the initial peak of coronavirus disease 2019 (COVID-19) infection risk in New York City from March 25 to April 21, 2020. STUDY DESIGN: This retrospective study evaluated absences at Morgan Stanley Children's Hospital. Clinical absences for (1) Columbia University ultrasonographers, (2) inpatient nurses, (3) labor and delivery operating room (OR) technicians, (4) inpatient obstetric nurse assistants, and (5) attending physicians providing inpatient obstetric services were analyzed. Causes of absences were analyzed and classified as illness, vacation and holidays, leave, and other causes. Categorical variables were compared with the chi-square test or Fisher's exact test. RESULTS: For nurses, absences accounted for 1,052 nursing workdays in 2020 (17.2% of all workdays) compared with 670 (11.1%) workdays in 2019 (p < 0.01). Significant differentials in days absent in 2020 compared with 2019 were present for (1) postpartum nurses (21.9% compared with 12.9%, p < 0.01), (2) labor and delivery nurses (14.8% compared with 10.6%, p < 0.01), and (3) antepartum nurses (10.2% compared with 7.4%, p = 0.03). Evaluating nursing assistants, 24.3% of workdays were missed in 2020 compared with 17.4% in 2019 (p < 0.01). For ultrasonographers, there were 146 absences (25.2% of workdays) in 2020 compared with 96 absences (16.0% of workdays) in 2019 (p < 0.01). The proportion of workdays missed by OR technicians was 22.6% in 2020 and 18.3% in 2019 (p = 0.25). Evaluating attending physician absences, a total of 78 workdays were missed due to documented COVID-19 infection. Evaluating the causes of absences, illness increased significantly between 2019 and 2020 for nursing assistants (42.6 vs. 57.4%, p = 0.02), OR technicians (17.1 vs. 55.9%, p < 0.01), and nurses (15.5 vs. 33.7%, p < 0.01). CONCLUSION: COVID-19 outbreak surge planning represents a major operational issue for medical specialties such as critical care due to increased clinical volume. Findings from this analysis suggest it is prudent to devise backup staffing plans. KEY POINTS: · 1) COVID-19 outbreak surge planning represents a major operational issue for obstetrics.. · 2) Inpatient obstetric volume cannot be reduced.. · 3) Staffing contingencies plans for nurses, sonographers, and physicians may be required..

Fetal growth velocity in diabetics and the risk for shoulder dystocia: a case-control study.

INTRODUCTION: Shoulder dystocia complicates up to 3% of vaginal births. The clinical ability to predict shoulder dystocia is limited, especially among diabetic women. We sought to evaluate if fetal growth trajectory measured from ultrasonographic (US) estimated fetal weight (EFW) percentiles was associated with increased risk for shoulder dystocia. METHODS: We performed a case-control study among women diagnosed with diabetes at a single institution between 2005 and 2015. Two diabetic controls without shoulder dystocia based on the year of delivery were included for each woman with a shoulder dystocia. Women with a single EFW measurement, delivery by cesarean, or multiple gestation were excluded. Demographic and US data were collected. Fetal growth trajectory was calculated from EFW measurements in the last two growth ultrasound scans performed closest to delivery. We compared the odds of EFW percentile change per week above specific thresholds for shoulder dystocia cases versus controls. The following cutoffs were generated: a mean percentile per week increase of > 0%, ≥ 0.5%, ≥ 1%, and ≥ 2%. Among those with EFW percentile changes that decreased (<0%), we evaluated whether odds of an abdominal circumference (AC) > 75th percentile or an EFW > 75th percentile was higher for women with shoulder dystocia. The primary exposure was increased growth trajectory. Secondary outcomes included analysis of the following adverse neonatal outcomes: (i) low 5 minutes Apgar score, (ii) rates of NICU admission, and (iii) neonatal demise. RESULTS: Of 3954 diabetics, we identified 68 cases with shoulder dystocia and 136 controls who did not have shoulder dystocia. Women who experienced a shoulder dystocia were more likely to be of advanced maternal age as compared to those without a shoulder dystocia (41.9% versus 23.5, p = .01); all other demographic characteristics were similar between groups. At growth trajectory cutoffs of > 0%, ≥ 0.5%, ≥ 1%, and ≥ 2% per week, odds ratios were increased among shoulder dystocia cases versus controls (OR = 1.8, 95% confidence interval (CI) = 0.9-3.3; OR = 1.6, 95% CI = 0.8-3.2; OR = 1.7, 95% CI = 0.7-3.9; and OR = 1.8, 95% CI = 0.6-5.3; respectively); however, this was not statistically significant. For women with fetal growth trajectories that decreased (< 0%), shoulder dystocia was associated with increased odds of fetal AC > 75th percentile and overall growth > 75th percentile (OR = 3.3, 95% CI = 1.5-7.1, OR = 4.8, 95% CI = 1.3-17.4, respectively). There was no difference in neonatal outcomes between shoulder dystocia cases and controls. CONCLUSION: Future research is required to determine if fetal growth velocity proves to be a useful tool in identifying women at increased risk for shoulder dystocia. Larger studies are required for precise estimates of risk, and associated neonatal outcomes.

Hypertensive disorders of pregnancy in twin gestations complicated by gestational diabetes.

Objective: Gestational diabetes (GDM) in singleton pregnancies is known to be associated with an increased risk for hypertensive disorders of pregnancy. The data are mixed regarding the effect of GDM on the risk for hypertensive disorders of pregnancy in twin gestations. The objective of our study was to assess the rate of hypertensive disorders of pregnancy in twin gestations complicated by GDM.Methods: This is a secondary analysis of a multicenter randomized trial in which twin gestations were assigned to weekly intramuscular injections of progesterone in order to reduce the rate of preterm birth. We included all twin pregnancies with and without GDM. Women with pregestational diabetes, chronic hypertension, twin pregnancies complicated by twin to twin transfusion syndrome and congenital fetal anomalies were excluded. Our primary outcome was the rate of hypertensive disorders in twin pregnancies complicated by GDM. Our secondary outcomes included the rate of cesarean section, number of neonates who were small for gestational age, Apgar scores, and a composite adverse neonatal outcome. Logistic regression analysis was used to control for confounding variables.Results: Six hundred fourteen twin pregnancies were included, 570 (93%) without GDM and 44 (7%) with GDM. The group with GDM had a significantly higher prepregnancy body mass index (BMI) and maternal age, and were more likely to have undergone in vitro fertilization (IVF). The rate of hypertensive disorders of pregnancy in the GDM group was significantly higher when compared to the non-GDM group (31.8 versus 17.9%, p = .033, RR 1.78 [95% CI = 1.11-2.84]); however, after adjusting for maternal age, IVF treatment and prepregnancy BMI, this association lost its statistical significance (aRR = 1.36 [95% CI = 0.83-2.21]). The cesarean section rate was higher in the GDM group as compared to the non-GDM group and after adjusting for confounders, the rate of cesarean section was still higher in the GDM group (77.3 versus 61.1%, p = .003, aRR = 1.27 [95% CI = 1.06-1.50]). Neonates born to women in the GDM group were more likely to experience the adverse composite outcome (26.4 versus 8.2%, p = 0.02, RR = 1.81 [95% CI = 1.09-2.99]).Conclusion: In this prospective cohort of twin pregnancies, the rate of hypertensive disorders of pregnancy did not differ between women with and without gestational diabetes after adjusting for maternal age, IVF treatment, race, and prepregnancy BMI. To better target complications associated with GDM in twin gestations, large prospective studies evaluating the effect of GDM on outcomes specifically in twin pregnancies are warranted.

Infection prevention and control for labor and delivery, well baby nurseries, and neonatal intensive care units.

During the early months of the COVID-19 pandemic, infection prevention and control (IP&C) for women in labor and mothers and newborns during delivery and receiving post-partum care was quite challenging for staff, patients, and support persons due to a relative lack of evidence-based practices, high rates of community transmission, and shortages of personal protective equipment (PPE). We present our IP&C policies and procedures for the obstetrical population developed from mid-March to mid-May 2020 when New York City served as the epicenter of the pandemic in the U.S. For patients, we describe screening for COVID-19, testing for SARS-CoV-2, and clearing patients from COVID-19 precautions. For staff, we address self-monitoring for symptoms, PPE in different clinical scenarios, and reducing staff exposures to SARS-CoV-2. For visitors/support persons, we address limiting them in labor and delivery, the postpartum units, and the NICU to promote staff and patient safety. We describe management of SARS-CoV-2-positive mothers and their newborns in both the well-baby nursery and in the neonatal ICU. Notably, in the well-baby nursery we do not separate SARS-CoV-2-positive mothers from their newborns, but emphasize maternal mask use and social distancing by placing newborns in isolates and asking mothers to remain 6 feet away unless feeding or changing their newborn. We also encourage direct breastfeeding and do not advocate early bathing. Newborns of SARS-CoV-2-positive mothers are considered persons under investigation (PUIs) until 14 days of life, the duration of the incubation period for SARS-CoV-2. We share two models of community-based care for PUI neonates. Finally, we provide our strategies for enhancing communication and education during the early months of the pandemic.

Conversion and optimization of telehealth in obstetric care during the COVID-19 pandemic.

When New York City became the international epicenter of the COVID-19 pandemic, telehealth at Columbia University Irving Medical Center was expanded in the inpatient and outpatient settings. The goals of telehealth during the pandemic were to maintain patient access to care while reducing the risk for COVID-19 exposure for patients and staff. Recommendations are made on how telehealth can be implemented and utilized to accomplish these goals. In the outpatient setting, virtual prenatal care visits and consultations can replace most in-person visits. When visitor restrictions are in effect telehealth can be used to engage support persons in the delivery room. Telehealth innovations can be leveraged to greatly improve care for COVID-19 mothers and their infants during the COVID-19 pandemic and beyond.

Adaptation of prenatal care and ultrasound.

In the spring of 2020, expeditious changes to obstetric care were required in New York as cases of COVID-19 increased and pandemic panic ensued. A reduction of in-person office visits was planned with provider appointments scheduled to coincide with routine maternal blood tests and obstetric ultrasounds. Dating scans were combined with nuchal translucency assessments to reduce outpatient ultrasound visits. Telehealth was quickly adopted for selected prenatal visits and consultations when deemed appropriate. The more sensitive cell-free fetal DNA test was commonly used to screen for aneuploidy in an effort to decrease return visits for diagnostic genetic procedures. Antenatal testing guidelines were modified with a focus on providing evidence-based testing for maternal and fetal conditions. For complex pregnancies, fetal interventions were undertaken earlier to avoid serial surveillance and repeated in-person hospital visits. These rapid adaptations to traditional prenatal care were designed to decrease the risk of coronavirus exposure of patients, staff, and physicians while continuing to provide safe and comprehensive obstetric care.

From the trenches: inpatient management of coronavirus disease 2019 in pregnancy.

The novel coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 has become a pandemic. It has quickly swept across the globe, leaving many clinicians to care for infected patients with limited information about the disease and best practices for care. Our goal is to share our experiences of caring for pregnant and postpartum women with novel coronavirus disease 2019 in New York, which is the coronavirus disease 2019 epicenter in the United States, and review current guidelines. We offer a guide, focusing on inpatient management, including testing policies, admission criteria, medical management, care for the decompensating patient, and practical tips for inpatient antepartum service management.

Inpatient obstetric management of COVID-19.

OBJECTIVE: To describe inpatient management strategies and considerations for pregnant patients with severe acute respiratory syndrome coronavirus 2 infection. FINDINGS: The novel coronavirus has posed challenges to both obstetric patients and the staff caring for them, due to its variable presentation and current limited knowledge about the disease. Inpatient antepartum, intrapartum and postpartum management can be informed by risk stratification, severity of disease, and gestational age. Careful planning and anticipation of emergent situations can prevent unnecessary exposures to patients and clinical staff. CONCLUSION: As new data arises, management recommendations will evolve, thus practitioners must maintain a low threshold for adaptation of their clinical practice during obstetric care for patients with severe acute respiratory syndrome coronavirus 2 infection.

Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.

BACKGROUND: Women with twin pregnancies and a dilated cervix in the second trimester are at increased risk of pregnancy loss and early preterm birth; there is currently no proven therapy to prevent preterm birth in this group of women. OBJECTIVE: This study aimed to determine whether physical examination-indicated cerclage reduces the incidence of preterm birth in women with a diagnosis of twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation. STUDY DESIGN: Multicenter, parallel group, open-label, randomized controlled trial of women with twin pregnancies and asymptomatic cervical dilation of 1 to 5 cm between 16 weeks 0/7 days of gestation and 23 weeks 6/7 days of gestation were enrolled from July 2015 to July 2019 in 8 centers. Eligible women were randomized in a 1:1 ratio into either cerclage or no cerclage groups. We excluded women with monochorionic-monoamniotic twin pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis. The primary outcome was the incidence of preterm birth at <34 weeks of gestation. Secondary outcomes were preterm births at <32, <28, and <24 weeks of gestation, interval from diagnosis to delivery, and perinatal mortality. Data were analyzed by intention-to-treat methods. RESULTS: After an interim analysis was performed, the Data and Safety Monitoring Board recommended stopping the trial because of a significant decrease in perinatal mortality in the cerclage group. We randomized 34 women, with 4 women being excluded because of expired informed consent. A total of 17 women were randomized to physical examination-indicated cerclage and 13 women to no cerclage. Whereas 4 women randomized to cerclage did not receive the surgical procedure, no women in the no cerclage group received cerclage. Maternal demographics were not significantly different. All women in the cerclage group also received indomethacin and antibiotics. When comparing the cerclage group vs the no cerclage group, the incidence of preterm birth was significantly decreased as follows: preterm birth at <34 weeks of gestation, 12 of 17 women (70%) vs 13 of 13 women (100%) (risk ratio, 0.71; 95% confidence interval, 0.52-0.96); preterm birth at <32 weeks of gestation, 11 of 17 women (64.7%) vs 13 of 13 women (100%) (risk ratio, 0.65; 95% confidence interval, 0.46-0.92); preterm birth at <28 weeks of gestation, 7 of 17 women (41%) vs 11 of 13 women (84%) (risk ratio, 0.49; 95% confidence interval, 0.26-0.89); and preterm birth at <24 weeks of gestation, 5 of 17 women (30%) vs 11 of 13 women (84%) (risk ratio, 0.35; 95% confidence interval, 0.16-0.75). The mean gestational age at delivery was 29.05±1.7 vs 22.5±3.9 weeks (P<.01), respectively; the mean interval from diagnosis of cervical dilation to delivery was 8.3±5.8 vs 2.9±3.0 weeks (P=.02), respectively. Perinatal mortality was also significantly reduced in the cerclage group compared with the no cerclage group as follows: 6 of 34 women (17.6%) vs 20 of 26 women (77%) (risk ratio, 0.22; 95% confidence interval, 0.1-0.5), respectively. CONCLUSION: In women with twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation, a combination of physical examination-indicated cerclage, indomethacin, and antibiotics significantly decreased preterm birth at all evaluated gestational ages. Most importantly, cerclage in this population was associated with a 50% decrease in early preterm birth at <28 weeks of gestation and with a 78% decrease in perinatal mortality.

Telehealth Uptake into Prenatal Care and Provider Attitudes during the COVID-19 Pandemic in New York City: A Quantitative and Qualitative Analysis.

OBJECTIVE: This study aimed to (1) determine to what degree prenatal care was able to be transitioned to telehealth at prenatal practices associated with two affiliated hospitals in New York City during the novel coronavirus disease 2019 (COVID-19) pandemic and (2) describe providers' experience with this transition. STUDY DESIGN: Trends in whether prenatal care visits were conducted in-person or via telehealth were analyzed by week for a 5-week period from March 9 to April 12 at Columbia University Irving Medical Center (CUIMC)-affiliated prenatal practices in New York City during the COVID-19 pandemic. Visits were analyzed for maternal-fetal medicine (MFM) and general obstetrical faculty practices, as well as a clinic system serving patients with public insurance. The proportion of visits that were telehealth was analyzed by visit type by week. A survey and semistructured interviews of providers were conducted evaluating resources and obstacles in the uptake of telehealth. RESULTS: During the study period, there were 4,248 visits, of which approximately one-third were performed by telehealth (n = 1,352, 31.8%). By the fifth week, 56.1% of generalist visits, 61.5% of MFM visits, and 41.5% of clinic visits were performed via telehealth. A total of 36 providers completed the survey and 11 were interviewed. Accessing technology and performing visits, documentation, and follow-up using the telehealth electronic medical record were all viewed favorably by providers. In transitioning to telehealth, operational challenges were more significant for health clinics than for MFM and generalist faculty practices with patients receiving public insurance experiencing greater difficulties and barriers to care. Additional resources on the patient and operational level were required to optimize attendance at in-person and video visits for clinic patients. CONCLUSION: Telehealth was rapidly implemented in the setting of the COVID-19 pandemic and was viewed favorably by providers. Limited barriers to care were observed for practices serving patients with commercial insurance. However, to optimize access for patients with Medicaid, additional patient-level and operational supports were required. KEY POINTS: · Telehealth uptake differed based on insurance.. · Medicaid patients may require increased assistance for telehealth.. · Quick adoption of telehealth is feasible..

Telehealth for High-Risk Pregnancies in the Setting of the COVID-19 Pandemic.

As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-19) pandemic, telehealth was rapidly integrated into prenatal care at Columbia University Irving Medical Center, an academic hospital system in Manhattan. Goals of implementation were to consolidate in-person prenatal screening, surveillance, and examinations into fewer in-person visits while maintaining patient access to ongoing antenatal care and subspecialty consultations via telehealth virtual visits. The rationale for this change was to minimize patient travel and thus risk for COVID-19 exposure. Because a large portion of obstetric patients had underlying medical or fetal conditions placing them at increased risk for adverse outcomes, prenatal care telehealth regimens were tailored for increased surveillance and/or counseling. Based on the incorporation of telehealth into prenatal care for high-risk patients, specific recommendations are made for the following conditions, clinical scenarios, and services: (1) hypertensive disorders of pregnancy including preeclampsia, gestational hypertension, and chronic hypertension; (2) pregestational and gestational diabetes mellitus; (3) maternal cardiovascular disease; (4) maternal neurologic conditions; (5) history of preterm birth and poor obstetrical history including prior stillbirth; (6) fetal conditions such as intrauterine growth restriction, congenital anomalies, and multiple gestations including monochorionic placentation; (7) genetic counseling; (8) mental health services; (9) obstetric anesthesia consultations; and (10) postpartum care. While telehealth virtual visits do not fully replace in-person encounters during prenatal care, they do offer a means of reducing potential patient and provider exposure to COVID-19 while providing consolidated in-person testing and services. KEY POINTS: · Telehealth for prenatal care is feasible.. · Telehealth may reduce coronavirus exposure during prenatal care.. · Telehealth should be tailored for high risk prenatal patients..