COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)
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ClinicalTrials.gov Identifier: NCT04705116 |
Recruitment Status :
Not yet recruiting
First Posted : January 12, 2021
Last Update Posted : January 13, 2021
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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 to prevent COVID-19.
Specifically, the C-VIPER will estimate the risk of obstetric outcomes (abortion, antenatal bleeding, dysfunctional labor, gestational diabetes, hypertensive disorders of pregnancy, intrauterine growth retardation, maternal death, non-reassuring fetal status, pathways to premature birth, postpartum hemorrhage, and COVID-19), neonatal outcomes (congenital anomalies, failure to thrive, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, and COVID-19), and infant outcomes (height, weight, health conditions, developmental milestones until one year of age, and COVID-19) among pregnant women exposed to a COVID-19 vaccine from 30 days prior to the first day of the last menstrual period to end of pregnancy and their offspring relative to a matched unexposed reference group.
Condition or disease | Intervention/treatment |
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Covid19 | Biological: COVID-19 vaccine |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 5000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 21 Months |
Official Title: | COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) |
Estimated Study Start Date : | January 15, 2021 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
Group/Cohort | Intervention/treatment |
---|---|
Vaccinated pregnant women
Pregnant women exposed from 30 days prior to the first day of the LMP to end of pregnancy to at least one dose of a COVID-19 vaccine
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Biological: COVID-19 vaccine
At least one dose of a COVID-19 vaccine. |
Non-vaccinated pregnant women
Pregnant women unexposed to a COVID-19 vaccine before enrollment and had a negative screening test for the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) during pregnancy.
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- Obstetric outcomes [ Time Frame: 1 year ]Number of pregnant women vaccinated against COVID-19 and number of pregnant women not vaccinated against COVID-19 who experience abortion, antenatal bleeding, dysfunctional labor, gestational diabetes, hypertensive disorders of pregnancy, intrauterine growth retardation, maternal death, non-reassuring fetal status, pathways to premature birth, postpartum hemorrhage, or COVID-19.
- Neonatal outcomes [ Time Frame: 1 year ]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 congenital anomalies, failure to thrive, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, or COVID-19.
- Infant weight [ Time Frame: 1 year ]Change in 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.
- Infant developmental milestones [ Time Frame: 1 year ]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.
- Infant COVID-19 diagnosis [ Time Frame: 1 year ]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 COVID-19 during the first year of life.
- Infant height [ Time Frame: 1 year ]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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Persons assigned gender female at birth. |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Pregnant women
- Aged 18 years or older
- Have received either:
- a COVID-19 vaccine from 30 days prior to the first day of the LMP to end of pregnancy or a negative screening test for SARS-CoV-2 during pregnancy
- Living in the countries where at least one COVID-19 vaccine is marketed
- Able and willing to sign the informed consent form agreeing to the conditions and requirements of the C-VIPER (exposed) or IRCEP extension (reference) using the studies website or mobile app.
- Willing to upload the minimum required data of the initial baseline questionnaire
Exclusion Criteria:
- <18 years of age

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705116
Contact: Diego Wyszynski, MD, MHS, PhD | 7472005468 | hello@pregistry.com |
United States, California | |
Pregistry | |
Los Angeles, California, United States, 90045 |
Principal Investigator: | Diego Wyszynski, MD, MHS, PhD | Pregistry |
Responsible Party: | Pregistry |
ClinicalTrials.gov Identifier: | NCT04705116 |
Other Study ID Numbers: |
PR004 |
First Posted: | January 12, 2021 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |