NCT04102644

Limiting Adverse Birth Outcomes in Resource-Limited Settings

Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12,020 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Birth Outcomes
• Labor and Delivery
• Respiratory Infection

Interventions

Type	Name	Description
OTHER	Observation	Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period

Timeline

• Start date: 2019-10-31
• Primary completion: 2022-08-08
• Completion: 2022-09-20
• First posted: 2019-09-25
• Last updated: 2022-09-27

Locations

4 sites across 3 countries: Ghana, India, Zambia