Limiting Adverse Birth Outcomes in Resource-Limited Settings (LABOR)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Infection; Labor and Delivery; Birth Outcomes
• Intervention / Treatment: Other: Observation

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 Type: Observational
• Enrollment (Actual): 12020

Contacts and Locations

Study Locations

• Ghana
  • Accra, Ghana
    • Korle Bu Teaching Hospital,
• India
  • Karnataka
    • Belgaum, Karnataka, India
      • Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research
  • Odisha
    • Balasore, Odisha, India
      • Fakir Mohan Medical College and Hospital
• Zambia
  • Lusaka, Zambia
    • Women and Newborn Hospital at University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria for women enrolled:

• Maternal age of majority
• Intrauterine singleton pregnancy

• Admission to the hospital for ANY of the following:

  1. vaginal delivery
  2. cesarean delivery in the presence of signs/symptoms of parturition, elevated blood pressure, or fever
  3. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Women; Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs)	Other: Observation; Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Bill and Melinda Gates Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Labor and Delivery; Childbirth in limited resource setting
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 19-0765; Z 31902 (Other Identifier: UNC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Deidentified individual data that supports the study results will be shared within 6 months of the publication of primary results.
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No