COVID-19 and Pregnancy Outcomes (COVID&PREG)

June 3, 2020 updated by: Universidade Nova de Lisboa

COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study.

Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Nova Medical School - UNL
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana M Campos, PhD,MD
        • Sub-Investigator:
          • Nadia Charepe, MSc, MD
        • Sub-Investigator:
          • Alexandra S Queiros, MD
        • Sub-Investigator:
          • Maria J Alves, MD
        • Sub-Investigator:
          • Teresa Ventura, PhD,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria: Pregnant women infected with Sars-Cov-2. Delivery at Portuguese maternities.

Exclusion Criteria: RT PCR SARS-CoV-2 negative.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 Neonatal Infection
Time Frame: 7 days
Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal mortality
Time Frame: 35 weeks
stillbirths and deaths in the first week of life
35 weeks
ICU maternal admission
Time Frame: 35 weeks
maternal ICU admission due to COVID-19
35 weeks
5 minute Apgar Score < 7
Time Frame: 1 day
Newborn 5 minute Apgar Score < 7
1 day
Preterm labour
Time Frame: 35 weeks
Delivery between 24 and 36 weeks
35 weeks
PPROM
Time Frame: 35 weeks
Preterm premature rupture of the membranes between 24 and 36 weeks
35 weeks
Miscarriage
Time Frame: 14 weeks
spontaneous pregnancy loss before 24 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2020

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID&PREG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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