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COVID-19 and Pregnancy Outcomes (COVID&PREG)

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: NCT04416373
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Universidade Nova de Lisboa

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.

Condition or disease Intervention/treatment
Coronavirus Infection Pregnancy Complications Vertical Transmission of Infectious Disease Breastfeeding Neonatal Infection Diagnostic Test: RT PCR SARS-CoV-2

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
Actual Study Start Date : March 22, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: RT PCR SARS-CoV-2
    Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
    Other Name: SARS-COV-2 Serologic test


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Perinatal mortality [ Time Frame: 35 weeks ]
    stillbirths and deaths in the first week of life

  2. ICU maternal admission [ Time Frame: 35 weeks ]
    maternal ICU admission due to COVID-19

  3. 5 minute Apgar Score < 7 [ Time Frame: 1 day ]
    Newborn 5 minute Apgar Score < 7

  4. Preterm labour [ Time Frame: 35 weeks ]
    Delivery between 24 and 36 weeks

  5. PPROM [ Time Frame: 35 weeks ]
    Preterm premature rupture of the membranes between 24 and 36 weeks

  6. Miscarriage [ Time Frame: 14 weeks ]
    spontaneous pregnancy loss before 24 weeks



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.


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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women infected with Sars-Cov-2 from 6 to 41 weeks.
Criteria

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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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): NCT04416373


Contacts
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Contact: Nadia Charepe, MD,MSc 00351213184000 nadia.charepe@chlc.min-saude.pt
Contact: Alexandra Queirós, MD 00351213184000 alexandra.queiros@nms.unl.pt

Locations
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Portugal
Nova Medical School - UNL Recruiting
Lisbon, Portugal
Contact: Nadia Charepe, MSc, MD    00351213184000    nadia.charepe@chlc.min-saude.pt   
Contact: Alexandra Queirós, MD    00351213184000    alexandra.queiros@nms.unl.pt   
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         
Sponsors and Collaborators
Universidade Nova de Lisboa
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Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT04416373    
Other Study ID Numbers: COVID&PREG
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pregnancy Complications
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases