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Completed

NCT Number: NCT04102644

Limiting Adverse Birth Outcomes in Resource-Limited Settings

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korle Bu Teaching Hospital,, Accra, Ghana

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for women enrolled:

  • 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
  • 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.

Treatment and study plan

observation

Other

Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period

Primary outcomes

  1. Number of cases of maternal death or severe morbidity

    Time frame: enrollment - 42 days postpartum

    Maternal composite: The combined number of maternal death or incident severe morbidity arising from hemorrhage, hypertension, or infection

  2. Number of cases of neonatal death or severe morbidity

    Time frame: enrollment - 42 days postpartum

    Fetal/Neonatal Composite: The combined number of Intrapartum stillbirths, neonatal deaths, neonatal encephalopathy, or neonatal sepsis

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

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

Acronym: LABOR

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2019
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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