NCT04416373

Brief Summary

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

3.7 years

First QC Date

May 29, 2020

Last Update Submit

June 3, 2020

Conditions

Coronavirus InfectionPregnancy ComplicationsVertical Transmission of Infectious DiseaseBreastfeedingNeonatal Infection

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 Neonatal Infection

    Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

    7 days

Secondary Outcomes (6)

  • Perinatal mortality

    35 weeks

  • ICU maternal admission

    35 weeks

  • 5 minute Apgar Score < 7

    1 day

  • Preterm labour

    35 weeks

  • PPROM

    35 weeks

  • +1 more secondary outcomes

Interventions

RT PCR SARS-CoV-2DIAGNOSTIC_TEST

Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

Also known as: SARS-COV-2 Serologic test

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women infected with Sars-Cov-2 from 6 to 41 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Medical School - UNL

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Coronavirus InfectionsPregnancy ComplicationsBreast Feeding

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Nadia Charepe, MD,MSc

CONTACT

00351213184000nadia.charepe@chlc.min-saude.pt

Alexandra Queirós, MD

CONTACT

00351213184000alexandra.queiros@nms.unl.pt

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 4, 2020

Study Start

March 22, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

PT(1)