COVID-19 Vaccines International Pregnancy Exposure Registry

NCT04705116 | Recruiting FDA Drug

• 1 other identifier: PR004
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-19 vaccine. Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes (major congenital malformations, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19), and infant outcomes (developmental milestones \[motor, cognitive, language, social-emotional, and mental health skills\], height, weight, failure to thrive, medical conditions during the first 12 months of life, COVID-19) among pregnant women exposed to single (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 days prior to the first day of the last menstrual period to end of pregnancy and their offspring relative to a matched reference group who received no COVID-19 vaccines during pregnancy.

Conditions

Covid19

Outcome Measures

Primary Outcomes (6)

• Obstetric outcomes

  Number of pregnant women vaccinated against COVID-19 and number of pregnant women not vaccinated against COVID-19 who experience spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, or COVID-19.

  1 year

• Neonatal outcomes

  Number of newborns of women vaccinated against COVID-19 and number of newborns of women not vaccinated against COVID-19 during pregnancy who are diagnosed with major congenital malformations, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, or COVID-19.

  1 year

• Infant weight

  Change in length and weight from birth to 3, 6, 9, and 12 months of age among newborns of women vaccinated against COVID-19 during pregnancy and among newborns of women not vaccinated against COVID-19 during pregnancy.

  1 year

• Infant developmental milestones

  Change in developmental milestones from baseline at 6, 9, and 12 months based on the tool Caregiver Reported Early Development Instruments among the offspring of women vaccinated against COVID-19 during pregnancy and among offspring of women not vaccinated against COVID-19 during pregnancy.

  1 year

• Infant COVID-19 diagnosis

  Number of newborns of women vaccinated against COVID-19 during pregnancy and number of newborns of women not vaccinated against COVID-19 during pregnancy diagnosed with failure to thrive, medical conditions, or COVID-19 during the first year of life.

  1 year

• Infant height

  Change in height from birth to 3, 6, 9, and 12 months of age among newborns of women vaccinated against COVID-19 during pregnancy and among newborns of women not vaccinated against COVID-19 during pregnancy.

  1 year

Study Arms (2)

Vaccinated pregnant women

Pregnant women who received at least one dose of a COVID-19 vaccine from 30 days prior to the first day of the LMP to end of pregnancy.

Biological: COVID-19 vaccine

Non-vaccinated pregnant women

Pregnant women who have not received a COVID-19 vaccine during pregnancy.

Interventions

COVID-19 vaccine BIOLOGICAL

At least one dose of a COVID-19 vaccine.

Vaccinated pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Persons assigned gender female at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target study population consists of pregnant women who are 18 years of age and older. The exposed group (Cohort 1) includes pregnant women who received at least one dose of a COVID-19 vaccine from 30 days prior to the first day of the LMP to end of pregnancy. The reference group (Cohort 2) includes pregnant women who have not received a COVID-19 vaccine during pregnancy. Women vaccinated against COVID-19 before 30 days prior to the first day of the LMP are eligible in the reference group. Both cohorts will be matched by country of residence and gestational age at enrollment (±2 weeks).

You may qualify if:

• Vaccinated population:
• Pregnant at time of enrollment
• Age ≥18 years at time of enrollment
• Signed the informed consent form and submitted the baseline module "COVID-19 Vaccination During This Pregnancy"
• Received at least one dose of a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP
• Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study
• Efforts will be made to obtain documentary evidence of COVID-19 vaccination.
• Comparison population:
• Pregnant at time of enrollment
• Age ≥18 years at time of enrollment
• Signed the informed consent form and submitted the minimum required data in the initial baseline questionnaire
• Have not received a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP
• Resident of a country where a Central IRB or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study

You may not qualify if:

• Not pregnant at time of enrollment
• Age \<18 years at time of enrollment

Sponsors & Collaborators

• Pregistry: lead

Study Sites (1)

Pregistry

Los Angeles, California, 90045, United States

RECRUITING

Related Publications (1)

• Wyszynski DF, Bhattacharya M, Martinez-Perez O, Scialli AR, Tassinari M, Bar-Zeev N, Renz C, Hernandez-Diaz S. The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations. Drug Saf. 2023 Mar;46(3):297-308. doi: 10.1007/s40264-022-01271-3. Epub 2023 Jan 22.

  PMID: 36682012 DERIVED

Related Links

• COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Cheryl Renz, MD

  Pregistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Renz, MD

CONTACT

18006163791; c-viper@pregistry.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 12, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)