Obstetric and Perinatal Outcomes of Women With COVID-19

NCT ID: NCT04369859

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

556 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-23

Study Completion Date

2022-01-15

Brief Summary

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently spreading rapidly around the globe, causing a major public health issue. There is currently very few data about the impact of COVID-19 on pregnancy, and potential in utero infection. This is a prospective observational study of COVID-19 diagnosed pregnant patients. This objective is to examine the impact of COVID-19 during pregnancy on the rates of obstetric and perinatal complications.

Detailed Description

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Clinical manifestations of COVID-19 can range from a benign upper respiratory tract infection to severe acute respiratory distress syndrome (ARDS), fatal in 1% of cases. However, pregnant women and their fetuses could particularly be vulnerable to the infection, as shown by previous human coronavirus outbreaks (SARS-CoV and MERS-CoV).

Cases will be recruited among all pregnant women aged \>18 years old who have tested positive for COVID-19 and are followed in a maternity belonging to the French South Regional Perinatology Network. Voluntary physicians will refer eligible participants to the study-coordinating center at APHM University Hospital. The participants will be followed by phone after having provided an informed consent. Clinical symptoms, laboratory and imaging findings, maternal and perinatal outcomes will be recorded.

Conditions

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Pregnant Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pregnant women with COVID-19

Pregnant women who have tested positive for COVID-19

Examine the impact of COVID-19 during pregnancy

Intervention Type BEHAVIORAL

clinical data collection

Interventions

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Examine the impact of COVID-19 during pregnancy

clinical data collection

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* Able to give informed consent
* Diagnosed with COVID-19

Exclusion Criteria

* Patients Refusing to Participate in the Study
* Patients who do not speak French well enough to benefit from clear and intelligible information
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Olivier ARNAUD, Director

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Assistance Publique Hôpitaux de Marseille

Marseille, PACA, France

Site Status

Countries

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France

Other Identifiers

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ID RCB

Identifier Type: OTHER

Identifier Source: secondary_id

2020-18

Identifier Type: -

Identifier Source: org_study_id

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