COVID&PREG: COVID-19 and Pregnancy Outcomes

• Sponsor: Universidade Nova de Lisboa (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04416373
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 44.3
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
• Actual Study Start Date: Mar 22, 2020
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. SARS-CoV-2 Neonatal Infection [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 [35 weeks]

   stillbirths and deaths in the first week of life

2. ICU maternal admission [35 weeks]

   maternal ICU admission due to COVID-19

3. 5 minute Apgar Score < 7 [1 day]

   Newborn 5 minute Apgar Score < 7

4. Preterm labour [35 weeks]

   Delivery between 24 and 36 weeks

5. PPROM [35 weeks]

   Preterm premature rupture of the membranes between 24 and 36 weeks

6. Miscarriage [14 weeks]

   spontaneous pregnancy loss before 24 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nova Medical School - UNL	Lisbon		Portugal

Sponsors and Collaborators

• Universidade Nova de Lisboa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidade Nova de Lisboa
• ClinicalTrials.gov Identifier: NCT04416373
• Other Study ID Numbers: COVID&PREG
• First Posted: Jun 4, 2020
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Coronavirus Infections; Pregnancy Complications

Study Results

No Results Posted as of Jun 4, 2020