Status:
COMPLETED
Limiting Adverse Birth Outcomes in Resource-Limited Settings
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Birth Outcomes
Labor and Delivery
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in sett...
Detailed Description
This is a prospective multi-country cohort study of up to 15,000 women admitted to the hospital for delivery or for management of respiratory infection. Women will be recruited and screened for study ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for women enrolled:
- Maternal age of majority
- Intrauterine singleton pregnancy
- Admission to the hospital for ANY of the following:
- vaginal delivery
- cesarean delivery in the presence of signs/symptoms of parturition, elevated blood pressure, or fever
- management of respiratory infection\*
- Ability and willingness to provide written informed consent
- Willingness to adhere to study procedures
- Willingness to provide locator information for follow-up
- Inclusion of participants admitted to hospital for management of respiratory infection applicable to Zambia site only.
- Exclusion Criteria for women enrolled:
- Admission to the hospital for cesarean delivery in the absence of signs/symptoms of parturition, elevated blood pressure, or fever
- Any condition (social or medical) that, in the opinion of study staff, would make participation unsafe or not feasible. Study staff may note physical, psychological, or social conditions that are not explicitly stated in the eligibility criteria that could make some women poor candidates for study participation.
Exclusion
Key Trial Info
Start Date :
October 31 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 20 2022
Estimated Enrollment :
12020 Patients enrolled
Trial Details
Trial ID
NCT04102644
Start Date
October 31 2019
End Date
September 20 2022
Last Update
September 27 2022
Active Locations (4)
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1
Korle Bu Teaching Hospital,
Accra, Ghana
2
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research
Belagavi, Karnataka, India
3
Fakir Mohan Medical College and Hospital
Balasore, Odisha, India
4
Women and Newborn Hospital at University Teaching Hospital
Lusaka, Zambia