Limiting Adverse Birth Outcomes in Resource-Limited Settings

Completed

• Conditions: Labor and Delivery; Birth Outcomes; Respiratory Infection
• Interventions: Other: Observation

• Registration Number: NCT04102644
• Lead Sponsor: University of North Carolina, Chapel Hill

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 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.

Study Timeline

• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Study Start: 2019-10-31
• Status Verified: 2022-02
• Primary Completion: 2022-08-08
• Study Completion: 2022-09-20
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12020

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women	Observation	Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs)

Primary Outcome Measures

Name	Time	Method
Number of cases of maternal death or severe morbidity	enrollment - 42 days postpartum	Maternal composite: The combined number of maternal death or incident severe morbidity arising from hemorrhage, hypertension, or infection
Number of cases of neonatal death or severe morbidity	enrollment - 42 days postpartum	Fetal/Neonatal Composite: The combined number of Intrapartum stillbirths, neonatal deaths, neonatal encephalopathy, or neonatal sepsis

Trial Locations

Locations (4)

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; 🇮🇳 Belgaum, Karnataka, India

Fakir Mohan Medical College and Hospital; 🇮🇳 Balasore, Odisha, India

Women and Newborn Hospital at University Teaching Hospital; 🇿🇲 Lusaka, Zambia