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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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
Pregnant Women Behavioral: Examine the impact of COVID-19 during pregnancy

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.

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical presentation [ Time Frame: 12 months ]
    To record clinical presentation of pregnant participants with COVID-19 by questionnaire and clinical evaluation



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Persons assigned gender female at birth
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

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

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): NCT04369859


Contacts
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Contact: Florence BRETELLE, PU-PH 491383791 ext +33 florence.bretelle@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, Paca, France, 13354
Contact: Florence BRETELLE, PU-PH    491383791 ext +33    florence.bretelle@ap-hm.fr   
Principal Investigator: Florence BRETELLE, PU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04369859    
Other Study ID Numbers: 2020-18
ID RCB ( Other Identifier: 2020-A00819-30 )
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No