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Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study
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 settings where the occurrence of adverse outcomes is high. The Investigators will gather detailed laboratory, physiologic, and clinical information, and precisely characterize major adverse diagnoses and outcomes. The resulting high-quality, granular, and generalizable data will be used to develop new algorithms to signal actionable intrapartum diagnoses and prospectively stratify women according to their risk for adverse maternal and neonatal outcomes.
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 participation at the time of presentation to the hospital. Participants will be assessed through hospitalization, labor, delivery, and discharge and at 1- and 6-week postpartum contacts. Liveborn infants will be enrolled at birth and followed through 42 days of life. The pilot phase of this protocol will enroll up to 500 women in labor and their newborns and follow them through labor, delivery, and 42 days postpartum.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Korle Bu Teaching Hospital,
Accra, Ghana
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research
Belagavi, Karnataka, India
Fakir Mohan Medical College and Hospital
Balasore, Odisha, India
Women and Newborn Hospital at University Teaching Hospital
Lusaka, Zambia
Start Date
October 31, 2019
Primary Completion Date
August 8, 2022
Completion Date
September 20, 2022
Last Updated
September 27, 2022
12,020
ACTUAL participants
Observation
OTHER
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
NCT07396428
NCT07278700
Data Source & Attribution
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