Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study.

BACKGROUND: Annually in the US, over 100,000 pregnant women with overt type 2 diabetes give birth. Strict maternal glycemic control is the key to optimizing infant outcomes. Medical treatment of type 2 diabetes in pregnancy is generally restricted to insulin, as data on the safety and efficacy of oral hypoglycemic agents in pregnancy are limited. However, over one-third of infants born to women with type 2 diabetes experience an adverse outcome, such as premature delivery, large-for-gestational age, hypoglycemia, hyperbilirubinemia, or birth trauma, suggesting that current treatment regimens fall short of optimizing outcomes. Metformin is the pharmacologic treatment of choice for type 2 diabetes outside of pregnancy. Metformin is favored over insulin because it results in less weight gain, fewer hypoglycemic episodes, and is administered orally rather than injected. However, metformin is not typically used for treatment of type 2 diabetes complicating pregnancy, mainly because no large clinical studies have been conducted to examine its use in this context. METHODS/DESIGN: This is a randomized double-blind multi-center clinical trial of insulin plus metformin versus insulin plus placebo for the treatment of type 2 diabetes complicating pregnancy. A total of 1200 women with type 2 diabetes will be randomized between 10 weeks 0 days' and 20 weeks 6 days' gestation and followed until 30 days after delivery. Neonate outcomes will be followed until 30 days of age. The primary aim is to compare the effect of insulin and metformin versus insulin and placebo on composite adverse neonatal outcomes, comprising perinatal mortality, preterm delivery, neonatal hypoglycemia, hyperbilirubinemia, large-for-gestational age small for gestational age, low birth weight, and/or birth trauma. Key secondary aims are to compare treatment groups for neonatal fat mass and rate of maternal hypoglycemia. Additional aims are to assess the side effects and safety of insulin and metformin among pregnant women with overt type 2 diabetes and to compare gestational weight gain among women treated with metformin plus insulin versus insulin alone. DISCUSSION: Successful completion of this study will result in high-quality, contemporary evidence for management of overt type 2 diabetes complicating pregnancy to improve neonatal outcomes. TRIAL REGISTRATION: NCT02932475 (05/17/2016).

Single-center serological surveillance of SARS-CoV-2 in pregnant patients presenting to labor and delivery.

OBJECTIVE: To measure maternal/fetal SARS-CoV-2 antibody levels. METHODS: A prospective observational study of eligible parturients admitted to the hospital for infant delivery was conducted between April and September 2020. SARS-CoV-2 antibody levels were measured in maternal and umbilical cord specimens using an in-house ELISA based on the receptor-binding domain (RBD) of the spike protein. Among SARS-CoV-2 seropositive patients, spike RBD antibody isotypes (IgG, IgM, and IgA) and ACE2 inhibiting antibodies were measured. RESULTS: In total, 402 mothers were enrolled and spike RBD antibodies in 388 pregnancies were measured (336 maternal and 52 cord specimens). Of them, 19 were positive (15 maternal, 4 cord) resulting in a seroprevalence estimate of 4.8% (95% confidence interval 2.9-7.4). Of the 15 positive maternal specimens, all had cord blood tested. Of the 15 paired specimens, 14 (93.3%) were concordant. Four of the 15 pairs were from symptomatic mothers, and all four showed high spike-ACE2 blocking antibody levels, compared to only 3 of 11 (27.3%) from asymptomatic mothers. CONCLUSION: A variable antibody response to SARS-CoV-2 in pregnancy among asymptomatic infections compared to symptomatic infections was found, the significance of which is unknown. Although transfer of transplacental neutralizing antibodies occurred, additional research is needed to determine how long maternal antibodies can protect the infant against SARS-CoV-2 infection.

Internet Use and Access Among Pregnant Women via Computer and Mobile Phone: Implications for Delivery of Perinatal Care.

BACKGROUND: The use of Internet-based behavioral programs may be an efficient, flexible method to enhance prenatal care and improve pregnancy outcomes. There are few data about access to, and use of, the Internet via computers and mobile phones among pregnant women. OBJECTIVE: We describe pregnant women's access to, and use of, computers, mobile phones, and computer technologies (eg, Internet, blogs, chat rooms) in a southern United States population. We describe the willingness of pregnant women to participate in Internet-supported weight-loss interventions delivered via computers or mobile phones. METHODS: We conducted a cross-sectional survey among 100 pregnant women at a tertiary referral center ultrasound clinic in the southeast United States. Data were analyzed using Stata version 10 (StataCorp) and R (R Core Team 2013). Means and frequency procedures were used to describe demographic characteristics, access to computers and mobile phones, and use of specific Internet modalities. Chi-square testing was used to determine whether there were differences in technology access and Internet modality use according to age, race/ethnicity, income, or children in the home. The Fisher's exact test was used to describe preferences to participate in Internet-based postpartum weight-loss interventions via computer versus mobile phone. Logistic regression was used to determine demographic characteristics associated with these preferences. RESULTS: The study sample was 61.0% white, 26.0% black, 6.0% Hispanic, and 7.0% Asian with a mean age of 31.0 (SD 5.1). Most participants had access to a computer (89/100, 89.0%) or mobile phone (88/100, 88.0%) for at least 8 hours per week. Access remained high (>74%) across age groups, racial/ethnic groups, income levels, and number of children in the home. Internet/Web (94/100, 94.0%), email (90/100, 90.0%), and Facebook (50/100, 50.0%) were the most commonly used Internet technologies. Women aged less than 30 years were more likely to report use of Twitter and chat rooms compared to women 30 years of age or older. Of the participants, 82.0% (82/100) were fairly willing or very willing to participate in postpartum lifestyle intervention. Of the participants, 83.0% (83/100) were fairly willing or very willing to participate in an Internet intervention delivered via computer, while only 49.0% (49/100) were fairly willing or very willing to do so via mobile phone technology. Older women and women with children tended to be less likely to desire a mobile phone-based program. CONCLUSIONS: There is broad access and use of computer and mobile phone technology among southern US pregnant women with varied demographic characteristics. Pregnant women are willing to participate in Internet-supported perinatal interventions. Our findings can inform the development of computer- and mobile phone-based approaches for the delivery of clinical and educational interventions.