GROCO: Obstetric and Perinatal Outcomes of Women With COVID-19
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| pregnant women with COVID-19 Pregnant women who have tested positive for COVID-19 |
Behavioral: Examine the impact of COVID-19 during pregnancy
clinical data collection
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Outcome Measures
Primary Outcome Measures
- Compare the complications rates [12 months]
To compare the complications rates of pregnant women tested positive for the SARS-CoV-2 (study group), with reference rates in a Covid-free population.
Secondary Outcome Measures
- Clinical presentation [12 months]
To record clinical presentation of pregnant participants with COVID-19 by questionnaire and clinical evaluation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant women
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Able to give informed consent
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Diagnosed with COVID-19
Exclusion Criteria:
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Patients Refusing to Participate in the Study
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Patients who do not speak French well enough to benefit from clear and intelligible information
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assistance Publique Hôpitaux de Marseille | Marseille | Paca | France | 13354 |
Sponsors and Collaborators
- Assistance Publique Hopitaux De Marseille
Investigators
- Study Director: Jean-Olivier ARNAUD, Director, Assistance Publique Hôpitaux de Marseille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-18
- ID RCB