Limiting Adverse Birth Outcomes in Resource-Limited Settings

Study Overview
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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.

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.

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

Conditions
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Birth Outcomes, Labor and Delivery, Respiratory Infection

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs) | Other: Observation<br>* Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor and Delivery, Childbirth in limited resource setting