Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    c viper
Previous Study | Return to List | Next Study

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 : June 8, 2021
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 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 or disease Intervention/treatment
Covid19 Biological: COVID-19 vaccine

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 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, 2025
Estimated Study Completion Date : December 31, 2025

Group/Cohort Intervention/treatment
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.



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 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, 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 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, or COVID-19.

  3. Infant weight [ Time Frame: 1 year ]
    Change in 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 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 or 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 at the time of enrollment and had a negative screening test for SARS-CoV-2 during pregnancy. Both cohorts will be matched by country of residence and gestational age at enrollment (+/- 1 week).
Criteria

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

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
Layout table for location contacts
Contact: Diego Wyszynski, MD, MHS, PhD 18006163791 c-viper@pregistry.com

Locations
Layout table for location information
United States, California
Pregistry Recruiting
Los Angeles, California, United States, 90045
Contact: Diego Wyszynski, MD, MHS, PhD         
Sponsors and Collaborators
Pregistry
Investigators
Layout table for investigator information
Principal Investigator: Diego Wyszynski, MD, MHS, PhD Pregistry
Additional Information:
Layout table for additonal information
Responsible Party: Pregistry
ClinicalTrials.gov Identifier: NCT04705116    
Other Study ID Numbers: PR004
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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