PregnancyNCT04826640
Observational Maternal COVID-19 Vaccination Study
An observational study of Pregnancy, run by Duke University at 4 sites in United States.
Trial summary
This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following the second vaccination using either identical web-based or paper diaries… Read more about this study
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 350 adult pregnant women aged 18-45 years at < 34 weeks gestation who plan on receiving COVID-19 vaccination during the current pregnancy in accordance with the Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians \& Gynecologists (ACOG) national recommendations.
Who may be able to join
- Pregnant women 18-45 years of age at the time of consent, inclusive
- Intention of receiving or within 1 day of receiving the first dose or only dose of COVID-19 vaccine based on Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians and Gynecologists (ACOG) guidelines in response to the FDA Emergency Use Authorization (EUA) and in conjunction with federal and local vaccination campaign distribution plans
- Willing to provide informed consent in a written or electronic format
- Gestational age at time of consent < 34 weeks 0 days based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA-EDD) will be based on reconciliation of "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
- Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.
- English or Spanish literate
Who cannot join
- Has immunosuppression as a result of an underlying illness or medications, such as antirejection/transplant regiments or immunomodulatory agents. Stable HIV disease is permitted per the following parameters:
- Confirmed stable HIV disease defined as document viral load <50 copies/mL and CD4 count >200 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months
- Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per the following parameters:
- If known HBV: confirmed inactive chronic HBV infection: HBsAg present for ≥6 months and HBeAg negative, anti-HBe positive; serum HBV DNA <2000 IU/mL; persistently normal ALT or AST levels; in those who had liver biopsy, findings that confirm absence of significant necroinflammation
- If known HCV: evidence of sustained virological response for ≥12 weeks after treatment or without evidence of HCV RNA viremia (undetectable HCV RNA)
- Use of oral, parenteral, or high-dose inhaled glucocorticoids
Show all 12Show fewer
- Has an active neoplastic disease (excluding non-melanoma skin cancer), including those who used anti-cancer chemotherapy or radiation therapy during the current pregnancy
- Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement)
- Known fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound
- Anyone who is already enrolled or plans to enroll in a randomized clinical trial with any drug, vaccine or medical device. Co-enrollment in behavioral or other observational intervention studies are allowed at any time.
- Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
- Anyone who is a relative of any research study personnel or is an employee supervised by study staff.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
Boston Medical Center
Boston, Massachusetts, 02118
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 27705
About this study
Official title: A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Pregnant Women
This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination.
Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following the second vaccination using either identical web-based or paper diaries, depending on study participant preference.
Read more
Maternal serum samples will be collected for antibody titers relevant to COVID-19 at time points that include: prior to vaccination, ~29 days post second vaccination, and at delivery. At Duke University, maternal and infant cord blood will be collected at delivery and analyzed for the same antibody titers. At other clinical sites, these delivery samples will only be collected if feasible.
Pregnant women will be followed through 90 days postpartum. with comprehensive obstetric and neonatal outcomes obtained from medical record review.
- Conditions
- Pregnancy
- Being tested
- Observational
- Keywords
- COVID-19 Vaccination, Immunizations in Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women who receive COVID-19 vaccine | Pregnant women who receive COVID-19 vaccine Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse pregnancy outcomes in pregnant women vaccinated with COVID-19 vaccine
As measured by the proportion of women experiencing one of the following:
Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death.
Measured: 12 months
Secondary outcomes (5)
Preterm birth after COVID-19 vaccination
As measured by proportions of preterm birth after COVID-19 vaccination
Measured: 12 months
Combined fetal and neonatal death after COVID-19 vaccination
As measured by proportions of combined fetal and neonatal death after COVID-19 vaccination
Measured: 12 months
Spontaneous abortion after COVID-19 vaccination
As measured by proportions of spontaneous abortion after COVID-19 vaccination
Measured: 12 months
Pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination
As measured by proportions of pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination
Measured: 7 days
Women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination
As measured by proportion of women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start24 May 2021
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Hospital Medical Center, Cincinnati, Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Geeta K Swamy, MD, Principal investigator, Duke UniversityKaren R Broder, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826640
- Sponsor's protocol ID
- Pro00107518
- Status last verified
- Jun 2023
- First submitted
- 30 Mar 2021
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Pregnant Women
- ClinicalTrials.gov ID
- NCT04826640
- Acronym / sponsor ID
- Pro00107518
- Conditions
- Pregnancy
- Keywords
- COVID-19 Vaccination, Immunizations in Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Hospital Medical Center, Cincinnati, Boston Medical Center
- Study start
- 24 May 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 1 Apr 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.
This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination.
Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following the second vaccination using either identical web-based or paper diaries, depending on study participant preference.
Maternal serum samples will be collected for antibody titers relevant to COVID-19 at time points that include: prior to vaccination, ~29 days post second vaccination, and at delivery. At Duke University, maternal and infant cord blood will be collected at delivery and analyzed for the same antibody titers. At other clinical sites, these delivery samples will only be collected if feasible.
Pregnant women will be followed through 90 days postpartum. with comprehensive obstetric and neonatal outcomes obtained from medical record review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who receive COVID-19 vaccine | – | Other: ObservationalPregnant women who receive COVID-19 vaccine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 350 adult pregnant women aged 18-45 years at < 34 weeks gestation who plan on receiving COVID-19 vaccination during the current pregnancy in accordance with the Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians \& Gynecologists (ACOG) national recommendations.
Key inclusion criteria (6 listed)
- Pregnant women 18-45 years of age at the time of consent, inclusive
- Intention of receiving or within 1 day of receiving the first dose or only dose of COVID-19 vaccine based on Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians and Gynecologists (ACOG) guidelines in response to the FDA Emergency Use Authorization (EUA) and in conjunction with federal and local vaccination campaign distribution plans
- Willing to provide informed consent in a written or electronic format
- Gestational age at time of consent < 34 weeks 0 days based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA-EDD) will be based on reconciliation of "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
- Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.
Key exclusion criteria (12 listed)
- Has immunosuppression as a result of an underlying illness or medications, such as antirejection/transplant regiments or immunomodulatory agents. Stable HIV disease is permitted per the following parameters:
- Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per the following parameters:
- Use of oral, parenteral, or high-dose inhaled glucocorticoids
- Has an active neoplastic disease (excluding non-melanoma skin cancer), including those who used anti-cancer chemotherapy or radiation therapy during the current pregnancy
- Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement)
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 |
|---|---|---|
| ObservationalObservational | Other | Pregnant women who receive COVID-19 vaccine |
Primary outcome
Adverse pregnancy outcomes in pregnant women vaccinated with COVID-19 vaccine
Time frame: 12 months
As measured by the proportion of women experiencing one of the following: Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death.
5 secondary outcomes
Preterm birth after COVID-19 vaccination
Time frame: 12 months
Combined fetal and neonatal death after COVID-19 vaccination
Time frame: 12 months
Spontaneous abortion after COVID-19 vaccination
Time frame: 12 months
Pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination
Time frame: 7 days
Women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination
Time frame: 3 months
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 10 Jul 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.
Geeta K Swamy, MD principal investigator
Duke University
Karen R Broder, MD principal investigator
Centers for Disease Control and Prevention
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Adverse pregnancy outcomes in pregnant women vaccinated with COVID-19 vaccine (time frame: 12 months). 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 10 Jul 2025.