COVID-19 Vaccines International Pregnancy Exposure Registry

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pregistry
Study ID
NCT04705116
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • COVID-19 vaccine — BIOLOGICAL
    At least one dose of a COVID-19 vaccine.

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
6,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Non-vaccinated pregnant women
    Pregnant women who have not received a COVID-19 vaccine during pregnancy.

Primary Outcome Measure

Obstetric outcomes [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PregistryLos AngelesCalifornia90045
Cheryl Renz, MD

Find similar trials in Los Angeles, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Pregistry· Los Angeles, CA

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