International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pregnancy

  SARS-CoV-2 test positive

  Exposure during pregnancy

  Stillbirth

  Abortion spontaneous

  Congenital anomaly

  Foetal malformation

  Pre-eclampsia

  Foetal growth restriction

Population studied

• Short description of the study population:
  The target study population consists of pregnant women, 18 years of age or older, tested for SARS-CoV-2 or with clinical confirmation of COVID-19, willing to provide information using the IRCEP website or mobile app. The rationale for including cases without a positive test is that in the worst-hit areas, where nucleic acid tests were scarce, epidemiological considerations and clinical symptoms (i.e., pneumonia, chest CT findings) sufficed to assign a diagnosis.; Inclusion criteria; 1. Pregnant women or women that delivered or had a pregnancy loss within the last 180 days; 2. Aged 18 years or older; 3. Tested for SARS-CoV-2 or had clinical confirmation of COVID-19 between the last menstrual period (LMP) and delivery; 4. Able and willing to sign the informed consent form agreeing to the conditions and requirements of the IRCEP, and; 5. Willing to upload the minimum required data of the initial baseline questionnaire
• Age groups:
  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  18000

Study design details

• Main study objective:
  The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) aims to describe the natural history of COVID-19 in pregnant women and to estimate the relative risk of major adverse obstetric and neonatal outcomes among women with varying degrees of severity and of timing of COVID-19 exposure and their offspring, respectively.
• Outcomes:
  Multiple maternal, obstetric, neonatal, and infant outcomes.
• Data analysis plan:
  There are two main data analyses: 1) a real-time descriptive surveillance that will report the COVID-19 characteristics and the frequency of outcomes in the exposed and control groups, and 2) hypothesis-based causal inference analyses that will investigate the potential effects of specific COVID-19 characteristics or treatments and will adjust through multivariate regression models or using propensity score (PS) matching to account for potential confounders, as appropriate.

Documents

Study, other information

Correspondence_for_IRB20-0622 6-8-2020

Sonia Hernandez-Diaz Correspondence_for_MOD20-0622-01