Covid19STOPCOVID19NCT04718220
Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
A study testing Antibody testing for SARS-CoV-2 IgG, Testing for SARS-CoV-2 RNA and Testing for SARS-CoV-2 IgM/IgG in people with Covid19 and Pregnancy Related, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19, Pregnancy Related, Maternal Complication of Pregnancy
- What is being tested?
- Antibody testing for SARS-CoV-2 IgG, Testing for SARS-CoV-2 RNA and Testing for SARS-CoV-2 IgM/IgG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical Center
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Covid19, Pregnancy Related, Maternal Complication of Pregnancy, Coronavirus, Neonatal Infection, Prenatal Stress
- Being tested
- Antibody testing for SARS-CoV-2 IgG, Testing for SARS-CoV-2 RNA, Testing for SARS-CoV-2 IgM/IgG
- 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
- Medical subject headings
- COVID-19, Coronavirus Infections, Premature Birth, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody testing for SARS-CoV-2 IgGDiagnostic test
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 RNADiagnostic test
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/IgGDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Unexposed (SARS-CoV-2 negative) cohort | Placebo comparator | Women who do not experience laboratory-confirmed SARS-CoV-2 infection during pregnancy. Receives: Diagnostic Test: Antibody testing for SARS-CoV-2 IgG |
| Exposed (SARS-CoV-2 positive) cohort | Active comparator | Women who experience laboratory-confirmed SARS-CoV-2 infection during pregnancy. Receives: Diagnostic Test: Testing for SARS-CoV-2 RNA; Diagnostic Test: Testing for SARS-CoV-2 IgM/IgG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks gestation until childbirth
Secondary outcomes (18)
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).
Measured: 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).
Measured: After 20 weeks gestation and up to 6 weeks postpartum
Rate of cesarean section
Delivery via a cesarean section operation.
Measured: Time of delivery
Rate of stillbirth
Fetal demise in utero after 20 weeks gestation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between conception and childbirth
Perinatal death
Fetal or neonatal death occurring after 20 weeks gestation and up to 21 days of life.
Measured: 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.
Measured: 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.
Measured: After delivery of newborn during delivery hospitalization
Rate of neonatal sepsis
Clinical syndrome that includes systemic signs of infection and bacteremia.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of delivery
Low birth weight
Weight at birth less than 2,500 grams.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Mar 2021
- Primary completion9 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Research
- Responsible party
- Principal investigator, Jeannie Kelly, Washington University School of Medicine
- Investigators
- Megan E Foeller, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718220
- Sponsor's protocol ID
- 202012075
- Acronym
- STOPCOVID19
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
- ClinicalTrials.gov ID
- NCT04718220
- Acronym / sponsor ID
- STOPCOVID19 / 202012075
- Conditions
- Covid19, Pregnancy Related, Maternal Complication of Pregnancy, Coronavirus, Neonatal Infection, Prenatal Stress
- Keywords
- pregnancy, COVID-19, SARS-CoV-2, antibody testing, pregnancy complication, maternal complication, neonatal complication, mother-to-fetal transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Mercy Research
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unexposed (SARS-CoV-2 negative) cohort | Placebo comparator | Diagnostic Test: Antibody testing for SARS-CoV-2 IgGWomen who do not experience laboratory-confirmed SARS-CoV-2 infection during pregnancy. |
| Exposed (SARS-CoV-2 positive) cohort | Active comparator | Diagnostic Test: Testing for SARS-CoV-2 RNA, Diagnostic Test: Testing for SARS-CoV-2 IgM/IgGWomen who experience laboratory-confirmed SARS-CoV-2 infection during pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibody testing for SARS-CoV-2 IgGWomen 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. | Diagnostic test | Unexposed (SARS-CoV-2 negative) cohort |
| Testing for SARS-CoV-2 RNAWomen 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. | Diagnostic test | Exposed (SARS-CoV-2 positive) cohort |
| Testing for SARS-CoV-2 IgM/IgGWomen 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. | Diagnostic test | Exposed (SARS-CoV-2 positive) cohort |
Primary outcome
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.
18 secondary outcomes
Rate of preeclampsia
Time frame: After 20 weeks gestation and up to 6 weeks postpartum
Rate of gestational hypertension
Time frame: After 20 weeks gestation and up to 6 weeks postpartum
Rate of cesarean section
Time frame: Time of delivery
Rate of stillbirth
Time frame: Between 20 weeks gestation and childbirth
Rate of fetal growth restriction
Time frame: Between conception and childbirth
Rate of fetal hydrops
Time frame: Between conception and childbirth
Rate of oligohydramnios
Time frame: Between conception and childbirth
Perinatal death
Time frame: During the pregnancy after 20 weeks of pregnancy to 21 days after delivery
Rate of premature preterm rupture of membranes
Time frame: Between conception and 36 weeks 6 days of pregnancy
Rate of neonatal intensive care unit (NICU) admission
Time frame: After delivery of newborn during delivery hospitalization
Rate of neonatal sepsis
Time frame: After delivery of newborn during delivery hospitalization up to 6 weeks of life
Rate of oxygen therapy
Time frame: After delivery of newborn during delivery hospitalization up to 6 weeks of life
Percentage of infants with low 5-minute Apgar
Time frame: At time of delivery
Percentage of infants with abnormal umbilical cord gas
Time frame: At time of delivery
Low birth weight
Time frame: At time of delivery
Confirmed congenital infection
Time frame: Testing will be conducted at time of delivery.
Probable congenital infection
Time frame: At time of delivery
Possible congenital infection
Time frame: At time of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan E Foeller, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibody testing for SARS-CoV-2 IgG, Testing for SARS-CoV-2 RNA and Testing for SARS-CoV-2 IgM/IgG in people with Covid19 and Pregnancy Related, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of preterm delivery (time frame: 20 weeks gestation until childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.