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OpenTrials
Completed

NCT Number: NCT04369859

Obstetric and Perinatal Outcomes of Women With COVID-19

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.

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Key information

Conditions

Pregnant Women

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, PACA, 13354, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Examine the impact of COVID-19 during pregnancy

Behavioral

clinical data collection

Primary outcomes

  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 outcomes

  1. Clinical presentation

    Time frame: 12 months

    To record clinical presentation of pregnant participants with COVID-19 by questionnaire and clinical evaluation

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Obstetric and Perinatal Outcomes of Women With COVID-19: A Prospective Cohort Study

Acronym: GROCO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2020
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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