Limiting Adverse Birth Outcomes in Resource-Limited Settings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12020 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-31

Study Completion Date

2022-09-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Birth Outcomes Labor and Delivery Respiratory Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women

Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs)

Observation

Intervention Type OTHER

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

Interventions

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Observation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes