Clinical trial NCT04718220: Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
Official title: Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Pregnancy Related
Maternal Complication of Pregnancy
Coronavirus
Neonatal Infection
Prenatal Stress
Preterm Birth
Keywords: pregnancy
COVID-19
SARS-CoV-2
antibody testing
pregnancy complication
maternal complication
neonatal complication
mother-to-fetal transmission
placental pathology
prenatal
stress
SARS-CoV-2 testing
social determinants of health
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Mercy Research
First posted: 2021-01-22
Enrollment: 448
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective study that will 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. Outcomes will be compared between the two cohorts.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria for exposed (SARS-CoV-2 positive) cohort:

* Viable intrauterine pregnancy
* Seroconversion or SARS-CoV-2 IgG antibodies or positive RT-PCR for SARS-CoV-2 during current pregnancy

Exclusion Criteria for exposed (SARS-CoV-2 positive) cohort:

* No viable intrauterine pregnancy
* No history of SARS-CoV-2 infection during pregnancy

Inclusion Criteria for unexposed (SARS-CoV-2 negative) cohort:

* Viable intrauterine pregnancy
* No history of SARS-CoV-2 infection prior to pregnancy

Exclusion Criteria for unexposed (SARS-CoV-2 negative) cohort:

* No viable intrauterine pregnancy
* Detection of SARS-CoV-2 IgG antibodies at enrollment

Primary outcomes:
measure: Rate of preterm delivery
timeFrame: 20 weeks gestation until childbirth
Secondary outcomes:
measure: Rate of preeclampsia
timeFrame: After 20 weeks gestation and up to 6 weeks postpartum
measure: Rate of gestational hypertension
timeFrame: After 20 weeks gestation and up to 6 weeks postpartum
measure: Rate of cesarean section
timeFrame: Time of delivery
measure: Rate of stillbirth
timeFrame: Between 20 weeks gestation and childbirth
measure: Rate of fetal growth restriction
timeFrame: Between conception and childbirth
measure: Rate of fetal hydrops
timeFrame: Between conception and childbirth
measure: Rate of oligohydramnios
timeFrame: Between conception and childbirth
measure: Perinatal death
timeFrame: During the pregnancy after 20 weeks of pregnancy to 21 days after delivery
measure: Rate of premature preterm rupture of membranes
timeFrame: Between conception and 36 weeks 6 days of pregnancy
measure: Rate of neonatal intensive care unit (NICU) admission
timeFrame: After delivery of newborn during delivery hospitalization
measure: Rate of neonatal sepsis
timeFrame: After delivery of newborn during delivery hospitalization up to 6 weeks of life
measure: Rate of oxygen therapy
timeFrame: After delivery of newborn during delivery hospitalization up to 6 weeks of life
measure: Percentage of infants with low 5-minute Apgar
timeFrame: At time of delivery
measure: Percentage of infants with abnormal umbilical cord gas
timeFrame: At time of delivery
measure: Low birth weight
timeFrame: At time of delivery
measure: Confirmed congenital infection
timeFrame: Testing will be conducted at time of delivery.
measure: Probable congenital infection
timeFrame: At time of delivery
measure: Possible congenital infection
timeFrame: At time of delivery
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Megan E Foeller, MD
role: PRINCIPAL_INVESTIGATOR
References: