observation
OtherDocumentation of course and outcome of hospitalization, labor, delivery, and postpartum period
NCT Number: NCT04102644
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Korle Bu Teaching Hospital,, Accra, Ghana
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for women enrolled:
Exclusion criteria
for women enrolled:
Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period
Time frame: enrollment - 42 days postpartum
Maternal composite: The combined number of maternal death or incident severe morbidity arising from hemorrhage, hypertension, or infection
Time frame: enrollment - 42 days postpartum
Fetal/Neonatal Composite: The combined number of Intrapartum stillbirths, neonatal deaths, neonatal encephalopathy, or neonatal sepsis
University of North Carolina, Chapel Hill
Other
Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study
Acronym: LABOR
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.
Published trials that share one or more normalized conditions with this study.
NCT04446611
Acquired Immunodeficiency Syndrome, Antenatal Care
East London, Eastern Cape, South Africa
View Trial DetailsNCT06503900
Adverse Event Following Immunization, Birth Outcomes
Atlanta, Georgia, United States
View Trial DetailsNCT04090762
Behavior, Birth Outcomes
Kano, Kano State, Nigeria
View Trial DetailsNCT06681675
Birth Comfort, Birth Outcomes
Konya, Turkey (Türkiye)
View Trial Details