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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
448
Women enrolled into the unexposed (SARS-CoV-2 negative) cohort will undergo testing for SARS-CoV-2 IgG antibodies at enrollment, every trimester of pregnancy, and during delivery hospitalization.
Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of placental tissue, umbilical cord blood, amniotic tissue, and neonates for SARS-CoV-2 RNA, as available.
Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of umbilical cord blood for SARS-CoV-2 IgG and IgM antibodies, as available.
Washington University Medical Center
St Louis, Missouri, United States
Rate of preterm delivery
Childbirth prior to 37 weeks of pregnancy, to be determined in accordance to standard pregnancy dating and the established estimated due date.
Time frame: 20 weeks gestation until childbirth
Rate of preeclampsia
Standard definitions will be used (new-onset presence of elevated blood pressure \> 140 systolic or \> 90 diastolic separated by \>4 hours and new onset proteinuria after 20 weeks of pregnancy or evidence of severe features of preeclampsia).
Time frame: After 20 weeks gestation and up to 6 weeks postpartum
Rate of gestational hypertension
Standard definitions of gestational hypertension will be used (new-onset presence of elevated blood pressure \> 140 systolic or \> 90 diastolic separated by \>4 hours without proteinuria after 20 weeks of pregnancy).
Time frame: After 20 weeks gestation and up to 6 weeks postpartum
Rate of cesarean section
Delivery via a cesarean section operation.
Time frame: Time of delivery
Rate of stillbirth
Fetal demise in utero after 20 weeks gestation.
Time frame: Between 20 weeks gestation and childbirth
Rate of fetal growth restriction
Estimated fetal weight by sonographic assessment less than the 10th percentile for gestational age.
Time frame: Between conception and childbirth
Rate of fetal hydrops
The presence of abnormally located fluid collections in two or more areas in the fetal body (i.e., fetal ascites and pericardial effusion) or one abnormal fluid collection plus fetal skin thickening.
Time frame: Between conception and childbirth
Rate of oligohydramnios
Estimated amniotic fluid index less than 5 or estimated deepest vertical pocket (no presence of umbilical cord) less than 2 by sonographic assessment.
Time frame: Between conception and childbirth
Perinatal death
Fetal or neonatal death occurring after 20 weeks gestation and up to 21 days of life.
Time frame: During the pregnancy after 20 weeks of pregnancy to 21 days after delivery
Rate of premature preterm rupture of membranes
Rupture of membranes prior to 37 weeks gestation.
Time frame: Between conception and 36 weeks 6 days of pregnancy
Rate of neonatal intensive care unit (NICU) admission
Admission of the newborn to the NICU after delivery during delivery hospitalization.
Time frame: After delivery of newborn during delivery hospitalization
Rate of neonatal sepsis
Clinical syndrome that includes systemic signs of infection and bacteremia.
Time frame: After delivery of newborn during delivery hospitalization up to 6 weeks of life
Rate of oxygen therapy
Use of oxygen therapy for the newborn after delivery during delivery hospitalization.
Time frame: After delivery of newborn during delivery hospitalization up to 6 weeks of life
Percentage of infants with low 5-minute Apgar
Five minute Apgar less than 7. Maximum 10, minimum 0. Higher scores typically have improved outcomes.
Time frame: At time of delivery
Percentage of infants with abnormal umbilical cord gas
pH of arterial blood of umbilical cord blood less than 7 and/or base excess greater than -12.
Time frame: At time of delivery
Low birth weight
Weight at birth less than 2,500 grams.
Time frame: At time of delivery
Confirmed congenital infection
SARS-CoV-2 RNA detection in the umbilical cord blood, in amniotic fluid if collected before rupture of membranes or in neonatal nasopharyngeal swabs collected both immediately after birth (and after cleaning of the infant).
Time frame: Testing will be conducted at time of delivery.
Probable congenital infection
SARS-CoV-2 RNA detection in the neonatal nasopharyngeal swabs collected immediately after birth (after cleaning of infant) and in the fetal side of the placenta.
Time frame: At time of delivery
Possible congenital infection
Anti-SARS-CoV-2 IgM antibodies detection in the umbilical cord blood but no SARS-CoV-2 RNA detected in the neonate.
Time frame: At time of delivery
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