Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

Covid19 Clinical Trial

— STOPCOVID19  

Official title:

Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04718220
• Other study ID #: 202012075
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Covid19
• Maternal Complication of Pregnancy
• Neonatal Infection
• Pregnancy Complications
• Pregnancy Related
• Premature Birth
• Prenatal Stress
• Preterm Birth

Intervention

Diagnostic Test:
• Antibody testing for SARS-CoV-2 IgG
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.
• Testing for SARS-CoV-2 RNA
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.
• Testing for SARS-CoV-2 IgM/IgG
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.

Locations

Country	Name	City	State
United States	Washington University Medical Center	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 weeks gestation until childbirth
Secondary	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).	After 20 weeks gestation and up to 6 weeks postpartum
Secondary	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).	After 20 weeks gestation and up to 6 weeks postpartum
Secondary	Rate of cesarean section	Delivery via a cesarean section operation.	Time of delivery
Secondary	Rate of stillbirth	Fetal demise in utero after 20 weeks gestation.	Between 20 weeks gestation and childbirth
Secondary	Rate of fetal growth restriction	Estimated fetal weight by sonographic assessment less than the 10th percentile for gestational age.	Between conception and childbirth
Secondary	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.	Between conception and childbirth
Secondary	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.	Between conception and childbirth
Secondary	Perinatal death	Fetal or neonatal death occurring after 20 weeks gestation and up to 21 days of life.	During the pregnancy after 20 weeks of pregnancy to 21 days after delivery
Secondary	Rate of premature preterm rupture of membranes	Rupture of membranes prior to 37 weeks gestation.	Between conception and 36 weeks 6 days of pregnancy
Secondary	Rate of neonatal intensive care unit (NICU) admission	Admission of the newborn to the NICU after delivery during delivery hospitalization.	After delivery of newborn during delivery hospitalization
Secondary	Rate of neonatal sepsis	Clinical syndrome that includes systemic signs of infection and bacteremia.	After delivery of newborn during delivery hospitalization up to 6 weeks of life
Secondary	Rate of oxygen therapy	Use of oxygen therapy for the newborn after delivery during delivery hospitalization.	After delivery of newborn during delivery hospitalization up to 6 weeks of life
Secondary	Percentage of infants with low 5-minute Apgar	Five minute Apgar less than 7. Maximum 10, minimum 0. Higher scores typically have improved outcomes.	At time of delivery
Secondary	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.	At time of delivery
Secondary	Low birth weight	Weight at birth less than 2,500 grams.	At time of delivery
Secondary	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).	Testing will be conducted at time of delivery.
Secondary	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.	At time of delivery
Secondary	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.	At time of delivery