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NCT04705116 · ClinicalTrials.gov registry record
COVID-19 Vaccines International Pregnancy Exposure Registry
A clinical trial of COVID-19, sponsored by Pregistry.
- Recruiting
- Registry status
- 6,000
- Enrollment target
- 1
- Study location
NCT04705116: Recruiting study of COVID-19, sponsored by Pregistry.
NCT04705116 is a study of COVID-19 that is actively recruiting participants, run by Pregistry. The registered enrollment target is 6,000 participants, below the 38,445-participant average among 298 other COVID-19 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04705116, a study of COVID-19, 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.
Primary Outcome
Number of pregnant women vaccinated against COVID-19 and number of pregnant women not vaccinated against COVID-19 who experience spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, or COVID-19.
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 |
What NCT04705116 shows while recruiting
NCT04705116 is an observational study that tracks outcomes without assigning an intervention. Its 6,000 participants enrollment target places it among the larger protocols in the corpus, below the 38,445-participant average among 298 other COVID-19 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which COVID-19 vaccine is the first listed.
NCT04705116 reports a single indexed study location in 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: COVID-19.
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.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04705116's enrollment target sits among peer trials
6,000 28th of 298 higher than 271 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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