Limiting Adverse Birth Outcomes in Resource-Limited Settings

Respiratory Infection Clinical Trial

— LABOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102644
• Other study ID #: 19-0765
• Secondary ID: Z 31902
• Status: Completed
• Start date: October 31, 2019
• Est. completion date: September 20, 2022

Study information

• Verified date: February 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12020
• Est. completion date: September 20, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Birth Outcomes
• Labor and Delivery
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Other:
• Observation
Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Bill and Melinda Gates Foundation

Countries where clinical trial is conducted

Ghana,  India,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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