Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Washington University School of Medicine
- Enrollment
- 448
- Locations
- 1
- Primary Endpoint
- Rate of preterm delivery
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.
Detailed Description
Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk of preterm birth, cesarean section, and maternal intensive care. The objectives of this study are to: (a) evaluate the full impact of SARS-CoV-2 in pregnancy to inform testing strategies, (b) examine the factors that impede testing during pregnancy, and (c) use study data to devise implementation strategies that improve SARS-CoV-2 testing in pregnancy and prenatal care during the pandemic. Investigators will prospectively enroll two cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2 antibodies will cross over to the exposed cohort. In Aim 1, investigators will evaluate patients' and providers' perceptions of SARS-CoV-2 testing during pregnancy and the influence of COVID-19 on maternal care-seeking behavior and anxiety via surveys and semi-structured interviews. In Aim 2, investigators will determine the effect of SARS-CoV-2 infection during pregnancy on the risk of preterm birth and other adverse pregnancy outcomes in symptomatic and asymptomatic disease. It is hypothesized that SARS-CoV-2 infection will increase the risk of preterm birth by 12%. In Aim 3, investigators will estimate the risk of mother-to-fetus SARS-CoV-2 transmission and viral presence in umbilical cord blood, placenta, and amniotic fluid by assaying for viral RNA in the neonate, cord blood, and placenta. Collectively, Aims 1-3 will be interpreted by investigators, the Scientific Advisory Board and the Community Advisory Board who will apply data to devising targeted implementation strategies designed for rapid community dissemination to improve testing and prenatal care.
Investigators
Jeannie Kelly
Assistant Professor
Washington University School of Medicine
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of preterm delivery
Time Frame: 20 weeks gestation until childbirth
Childbirth prior to 37 weeks of pregnancy, to be determined in accordance to standard pregnancy dating and the established estimated due date.
Secondary Outcomes
- Rate of preeclampsia(After 20 weeks gestation and up to 6 weeks postpartum)
- Perinatal death(During the pregnancy after 20 weeks of pregnancy to 21 days after delivery)
- Rate of fetal hydrops(Between conception and childbirth)
- Rate of gestational hypertension(After 20 weeks gestation and up to 6 weeks postpartum)
- Rate of cesarean section(Time of delivery)
- Rate of stillbirth(Between 20 weeks gestation and childbirth)
- Rate of fetal growth restriction(Between conception and childbirth)
- Rate of neonatal sepsis(After delivery of newborn during delivery hospitalization up to 6 weeks of life)
- Rate of oxygen therapy(After delivery of newborn during delivery hospitalization up to 6 weeks of life)
- Percentage of infants with low 5-minute Apgar(At time of delivery)
- Possible congenital infection(At time of delivery)
- Rate of oligohydramnios(Between conception and childbirth)
- Rate of premature preterm rupture of membranes(Between conception and 36 weeks 6 days of pregnancy)
- Low birth weight(At time of delivery)
- Confirmed congenital infection(Testing will be conducted at time of delivery.)
- Rate of neonatal intensive care unit (NICU) admission(After delivery of newborn during delivery hospitalization)
- Probable congenital infection(At time of delivery)
- Percentage of infants with abnormal umbilical cord gas(At time of delivery)