RECRUITING

COVID-19 Vaccines International Pregnancy Exposure Registry

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04705116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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	* Not pregnant at time of enrollment * Age \<18 years at time of enrollment

Inclusion Criteria

Exclusion Criteria

* 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
* 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

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

Contacts and Locations

Study Contact

Diego Wyszynski, MD, MHS, PhD

CONTACT

18006163791

c-viper@pregistry.com

Principal Investigator

Diego Wyszynski, MD, MHS, PhD

PRINCIPAL_INVESTIGATOR

Pregistry

Study Locations (Sites)

Pregistry

Los Angeles, California, 90045

United States

Collaborators and Investigators

Sponsor: Pregistry

Diego Wyszynski, MD, MHS, PhD, PRINCIPAL_INVESTIGATOR, Pregistry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Covid19