Limiting Adverse Birth Outcomes in Resource-Limited Settings
LABOR
2 other identifiers
observational
12,020
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedStudy Start
First participant enrolled
October 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2022
CompletedSeptember 27, 2022
February 1, 2022
2.8 years
September 23, 2019
September 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of cases of maternal death or severe morbidity
Maternal composite: The combined number of maternal death or incident severe morbidity arising from hemorrhage, hypertension, or infection
enrollment - 42 days postpartum
Number of cases of neonatal death or severe morbidity
Fetal/Neonatal Composite: The combined number of Intrapartum stillbirths, neonatal deaths, neonatal encephalopathy, or neonatal sepsis
enrollment - 42 days postpartum
Study Arms (1)
Pregnant Women
Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs)
Interventions
Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period
Eligibility Criteria
Pregnant women and their fetuses/newborns at the Women and Newborn Hospital of the University Teaching Hospital in Lusaka, Zambia; Korle-bu Teaching Hospital in Accra, Ghana; Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research in Belagavi, Karnataka India; and Fakir Mohan Medical College and Hospital in Balasore, Odisha, India.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Belagavi, Karnataka, India
Fakir Mohan Medical College and Hospital
Balasore, Odisha, India
Women and Newborn Hospital at University Teaching Hospital
Lusaka, Zambia
Related Publications (1)
Walter JR, Xu S, Rogers JA. From lab to life: how wearable devices can improve health equity. Nat Commun. 2024 Jan 2;15(1):123. doi: 10.1038/s41467-023-44634-9.
PMID: 38167483DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Stringer, MD, FACOG
University of North Carolina, Chapel Hill
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2019
First Posted
September 25, 2019
Study Start
October 31, 2019
Primary Completion
August 8, 2022
Study Completion
September 20, 2022
Last Updated
September 27, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Deidentified individual data that supports the study results will be shared within 6 months of the publication of primary results.
- Access Criteria
- See plan description
Deidentified individual data that support the study results will be shared within 6 months of the publication of primary results. As this is a multi-country study with data sharing governed by multiple research ethics and governmental oversight entities, data sharing will be subject to each country providing individual approval in accordance with its own local regulatory requirements.