Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04705116
Status
Not yet recruiting
Sponsor
Pregistry

Study Contact

Diego Wyszynski, MD, MHS, PhD
7472005468
hello@pregistry.com

Detailed Description

Rationale and background: COVID-19 vaccines will be used in pregnant populations. Scientific evidence regarding their safety for pregnant women and the developing fetus is lacking. Objective: The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to estimate the relative 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 (LMP) to end of pregnancy and their offspring compared to an unexposed reference group. Study design: The C-VIPER is an international, noninterventional, post-marketing cohort study designed to collect prospective safety data among women vaccinated during pregnancy to prevent COVID-19. Population: The study population includes 2 cohorts of pregnant women 18 years of age and older matched by country and gestational age (+/- 1 week): - Cohort 1: 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. These participants are enrolled as part of the C-VIPER. - Cohort 2: 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. These participants are enrolled through the International Coronavirus Exposure in Pregnancy (IRCEP) with the same methods as those in Cohort 1. Registration and participation via website or mobile app especially developed for the C-VIPER are voluntary. Eligible women can enroll at any time during pregnancy. Data collection: Pregnancy data are collected at enrollment, monthly, and at the end of pregnancy. Liveborn infants are followed-up to one year of age and data are collected at birth and then every three months until 12 months of age. Information is obtained directly from the participant. The C-VIPER collects data on potential confounding factors (such as maternal sociodemographic characteristics, behaviors, reproductive history, chronic conditions, results of SARS-CoV-2 tests before and during this pregnancy, new COVID-19 vaccinations, use of medications, and measures of healthcare utilization), and information related to obstetric, neonatal, and infant outcomes. Given the international nature of the C-VIPER, the questionnaires are available in the languages spoken where it is conducted. Participant confidentiality and anonymity are strictly upheld. Analysis: Exposure to the vaccine during specific etiologically relevant periods is considered when estimating the risk for each outcome (e.g., first trimester for miscarriages and malformations). Relative risks are presented unadjusted and adjusted using propensity scores (PS) to account for imbalances in characteristics between the exposed and the reference groups. Sample size: At least 200 pregnancies exposed to each branded COVID-19 vaccine during the first trimester and 300 exposed thereafter during pregnancy are projected. For each exposed pregnancy, 2 unexposed pregnancies enrolled in the IRCEP will be matched by country and gestational age at enrollment (+/- 1 week). Study Milestones: The total duration of the study will be 5 years. Obstetric, neonatal, and infant outcomes will be assessed on an ongoing basis as data become available. The first two years will include, primarily, enrollment of pregnancies; the third and fourth years will involve follow-up of pregnancies and newborns; and, the final year, will be for data analyses and publications. Annual interim reports will be submitted to the Scientific Advisory Committee (SAC) for their review and feedback as well as abbreviated semiannual progress reports summarizing cumulative results on key outcomes. A final report will be prepared at the end of the study. Governance: The C-VIPER is conducted by Pregistry and includes an internal Safety Management Team (SMT) of experienced pharmacovigilance professionals and a dysmorphologist that meet regularly to review individual cases and safety signals. Additionally, the C-VIPER is in consultation with experts from relevant fields, such as maternal-fetal medicine, infectious diseases, epidemiology, and biostatistics from academic institutions, private practice, and/or government agencies. These individuals constitute the SAC and will provide an independent review of the C-VIPER data. Sponsors: Pharmaceutical companies that hold marketing authorization of COVID-19 vaccines are invited to sponsor the C-VIPER. The C-VIPER will make an effort to enable Sponsors to meet regulatory requirements related to pregnancy exposure to COVID-19 vaccines.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.