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NCT04705116 · ClinicalTrials.gov registry record
COVID-19 Vaccines International Pregnancy Exposure Registry
A clinical trial of Covid19, sponsored by Pregistry.
- Recruiting
- Registry status
- 6,000
- Enrollment target
- 1
- Study location
NCT04705116 is a study of Covid19 that is actively recruiting participants, run by Pregistry. The registered enrollment target is 6,000 participants, above the 2,638-participant average among 94 other Covid19 trials with a reported enrollment target (127% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04705116, a study of Covid19, is actively recruiting participants, sponsored by Pregistry.
- RECRUITING
- Registry status
- 6,000 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BIOLOGICAL COVID-19 vaccine
Study Locations (1)
California
- Pregistry - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,000 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2026-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04705116
The ClinicalTrials.gov registry entry for NCT04705116 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 6,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,638-participant average among 94 other Covid19 trials with a reported enrollment target (127% higher). The listed sponsor is Pregistry, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Covid19 appearing as the primary indexed condition, and to 1 intervention - of which COVID-19 vaccine is the first listed.
NCT04705116 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04705116 about?
NCT04705116 is a clinical study titled "COVID-19 Vaccines International Pregnancy Exposure Registry". 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 abo...
What is the current status of trial NCT04705116?
This trial is currently recruiting. The enrollment target is 6,000 participants. The study started on 2021-06-01. Estimated completion is 2026-12-31.
What conditions does trial NCT04705116 study?
This clinical trial studies the following conditions: Covid19.
What interventions are being tested in trial NCT04705116?
The interventions under investigation include: COVID-19 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04705116?
This trial is sponsored by Pregistry, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04705116 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.