Obstetric and Perinatal Outcomes of Women With COVID-19 (GROCO)
|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: NCT04369859|
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 4, 2020
|Condition or disease||Intervention/treatment|
|Pregnant Women||Behavioral: Examine the impact of COVID-19 during pregnancy|
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 Type :||Observational|
|Estimated Enrollment :||1300 participants|
|Official Title:||Obstetric and Perinatal Outcomes of Women With COVID-19: A Prospective Cohort Study|
|Actual Study Start Date :||April 23, 2020|
|Estimated Primary Completion Date :||April 22, 2021|
|Estimated Study Completion Date :||April 22, 2021|
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
- Compare the complications rates [ Time Frame: 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.
- Clinical presentation [ Time Frame: 12 months ]To record clinical presentation of pregnant participants with COVID-19 by questionnaire and clinical evaluation
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): NCT04369859
|Contact: Florence BRETELLE, PU-PH||491383791 ext +firstname.lastname@example.org|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, Paca, France, 13354|
|Contact: Florence BRETELLE, PU-PH 491383791 ext +33 email@example.com|
|Principal Investigator: Florence BRETELLE, PU-PH|
|Study Director:||Jean-Olivier ARNAUD, Director||Assistance Publique Hôpitaux de Marseille|