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Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns (Coropreg)

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. Identifier: NCT04463758
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
INSERM, Epopé team
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context

Condition or disease Intervention/treatment
covid19 Infection Pregnancy Complications Neonatal Complications Other: An auto-questionnaire comprising three psychometric scales

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Study Type : Observational
Estimated Enrollment : 3060 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : October 2022

Intervention Details:
  • Other: An auto-questionnaire comprising three psychometric scales

    three psychometric scales validated in French: _depression (Edinburgh Postpartum Depression Scale (EPDS)), anxiety (State-Trait Anxiety Inventory (STAI)

    - and Impact of Event Scale (Revised) (IES-R)

Primary Outcome Measures :
  1. Joint evaluation of morbi-mortality for mother and child up to 12 weeks postpartum [ Time Frame: At12 weeks after delivery ]

    Maternal Criterion: Validated Composite Criterion of Severe Maternal Morbidity (Epimoms study ref 7).

    Neonatal Criterion: Mortality and Composite Criterion of Severe Neonatal Morbidity Perinatal asphyxia (arterial pH to cord-7.15 and/or an excess base - 10mmol/L and/or lactates-6 mmol/L, Apgar score at 5 minutes -7), neonatal encephalopathy, seizures, intraventricular hemorrhage, cerebral infarction, periventricular leucomalacia, ulcerative enterocolite, sepsis, respiratory distress syndrome, bronchopulmonary dysplasia, central catheter, ventilatory support, transfusion

Secondary Outcome Measures :
  1. Number of women infection COVID-19 [ Time Frame: During pregnancy and up to 12 weeks ]
  2. Severe forms of COVID-19 infection in the mother [ Time Frame: Until 12 weeks after delivery ]
  3. Severe neonatal morbidity [ Time Frame: Until 12 weeks after delivery ]

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:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All pregnant or recently pregnant women managed in one maternity unit of the 16 participating perinatal networks

Inclusion Criteria:

  • Any woman with :

either proven COVID-19 infection= positive PCR test, OR probable COVID-19 infection = typical clinical symptoms AND typical pulmonary radiology

  • during pregnancy or within 42 days postpartum,
  • whether or not this diagnosis is followed by hospitalization,

Exclusion Criteria:

  • Refusal to participate
  • Major protected (curator, trusteeship)

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 identifier (NCT number): NCT04463758

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Contact: Catherine Deneux-Tharaux, MD, PhD +33 1 42 34 55 79
Contact: Laurence Lecomte, PhD +33 1 58 41 34 78

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AP-HP Cochin Recruiting
Paris, France, 75014
Contact: Jean-Marc Treluyer, M.D., PhD    + 00 1 58 41 28 85   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
INSERM, Epopé team
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Principal Investigator: Pierre Yv Ancel, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT04463758    
Other Study ID Numbers: APHP200513
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Maternal morbidity
Perinatal mortality
Neonatal morbidity
Additional relevant MeSH terms:
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Pregnancy Complications