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A prospective cohort study of the effects of COVID-19 in pregnancy and the neonatal period

A prospective cohort study of the effects of COVID-19 in pregnancy and the neonatal period - INTERCOVID

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/09/028162
Enrollment
1500
Registered
2020-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Control Intervention1: NA: Two Pregnant/ Delievered women without COVID Infection consecutively following one COVID Positive Pregnant/ Delievered women.

Sponsors

Not Funded
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: â??Exposedâ?? cases are defined as pregnant women with either: a) laboratory confirmed COVID-19; b) radiological pulmonary findings suggestive of COVID-19; c) maternal symptoms compatible with COVID-19 according to a predefined list, or d) absence of symptoms, whilst in close interaction with a person(s) with confirmed COVID-19 (a proxy for asymptomatic cases, one of the main problems in controlling the pandemic). â??Exposedâ?? cases will be compared with two â??non-exposedâ?? pregnant women per case considered as representative of the pregnant population at each study site. The selection of the â??non-exposedâ?? women is a central point of the study to reduce selection bias.

Exclusion criteria

Exclusion criteria: Non- Pregnant women

Design outcomes

Primary

MeasureTime frame
1] maternal pregnancy-related morbidities 2] an unweighted â??maternal morbidity indexâ??. 3]neonatal outcomes: a) the â??severe neonatal morbidity indexâ?? b)the â??neonatal morbidity and mortality indexTimepoint: 7,14,21,28 days whilst the mother and /or child remain in the hospital. Stay in Neonatal Intensive Care Unit (NICU) for â?¥7 days, or severe neonatal complications.

Secondary

MeasureTime frame
Each individual component of the indices will be evaluated as secondary outcomes. Timepoint: 7,14,21,28 days whilst the mother and /or child remain in the hospital. Stay in Neonatal Intensive Care Unit (NICU) for â?¥7 days, or severe neonatal complications.

Countries

Argentina, Brazil, Egypt, France, Ghana, India, Indonesia, Italy, Japan, Macedonia, Mexico, Nigeria, Pakistan, Russian Federation, Spain, United Kingdom, United States of America

Contacts

Public ContactDr Manjushri Waikar

Department of Obstetrics and Gynecology, Government Medical College, Nagpurt

manjuw123@gmail.com9823099031

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026