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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04705116
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Pregistry

Brief 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.


Condition or disease Intervention/treatment
Covid19 Biological: COVID-19 vaccine

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Months
Official Title: COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Biological: COVID-19 vaccine
At least one dose of a COVID-19 vaccine.

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



Primary Outcome Measures :
  1. Obstetric outcomes [ Time Frame: 1 year ]
    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.

  2. Neonatal outcomes [ Time Frame: 1 year ]
    Number of newborns of women vaccinated against COVID-19 and number of newborns of women not vaccinated against COVID-19 during pregnancy who are diagnosed with 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, or COVID-19.

  3. Infant weight [ Time Frame: 1 year ]
    Change in length and weight from birth to 3, 6, 9, and 12 months of age among newborns of women vaccinated against COVID-19 during pregnancy and among newborns of women not vaccinated against COVID-19 during pregnancy.

  4. Infant developmental milestones [ Time Frame: 1 year ]
    Change in developmental milestones from baseline at 6, 9, and 12 months based on the tool Caregiver Reported Early Development Instruments among the offspring of women vaccinated against COVID-19 during pregnancy and among offspring of women not vaccinated against COVID-19 during pregnancy.

  5. Infant COVID-19 diagnosis [ Time Frame: 1 year ]
    Number of newborns of women vaccinated against COVID-19 during pregnancy and number of newborns of women not vaccinated against COVID-19 during pregnancy diagnosed with failure to thrive, medical conditions, or COVID-19 during the first year of life.

  6. Infant height [ Time Frame: 1 year ]
    Change in height from birth to 3, 6, 9, and 12 months of age among newborns of women vaccinated against COVID-19 during pregnancy and among newborns of women not vaccinated against COVID-19 during pregnancy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Persons assigned gender female at birth.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The target study population consists of pregnant women who are 18 years of age and older. The exposed group (Cohort 1) includes 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. The reference group (Cohort 2) includes pregnant women who have not received a COVID-19 vaccine during pregnancy. Women vaccinated against COVID-19 before 30 days prior to the first day of the LMP are eligible in the reference group. Both cohorts will be matched by country of residence and gestational age at enrollment (±2 weeks).
Criteria

Inclusion criteria:

Vaccinated population:

  • 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

Efforts will be made to obtain documentary evidence of COVID-19 vaccination.

Comparison population:

  • 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

Exclusion criteria:

  • Not pregnant at time of enrollment
  • Age <18 years at time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705116


Contacts
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Contact: Diego Wyszynski, MD, MHS, PhD 18006163791 c-viper@pregistry.com

Locations
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United States, California
Pregistry Recruiting
Los Angeles, California, United States, 90045
Contact: Diego Wyszynski, MD, MHS, PhD         
Sponsors and Collaborators
Pregistry
Investigators
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Principal Investigator: Diego Wyszynski, MD, MHS, PhD Pregistry
Additional Information:
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Responsible Party: Pregistry
ClinicalTrials.gov Identifier: NCT04705116    
Other Study ID Numbers: PR004
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases