Clinical trial NCT04102644: Limiting Adverse Birth Outcomes in Resource-Limited Settings
Official title: Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Outcomes
Labor and Delivery
Respiratory Infection
Keywords: Labor and Delivery
Childbirth in limited resource setting
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2019-09-25
Enrollment: 12020
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of cases of maternal death or severe morbidity
timeFrame: enrollment - 42 days postpartum
measure: Number of cases of neonatal death or severe morbidity
timeFrame: enrollment - 42 days postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Korle Bu Teaching Hospital,
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research
state: Karnataka
city: Balasore
country: India
facility: Fakir Mohan Medical College and Hospital
state: Odisha
city: Lusaka
country: Zambia
facility: Women and Newborn Hospital at University Teaching Hospital
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jeff Stringer, MD, FACOG
role: PRINCIPAL_INVESTIGATOR
References: