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| ID | Type | Description | Link |
|---|---|---|---|
| Z 31902 | Other Identifier | UNC |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women | Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period |
|
| 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 |
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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:
Ability and willingness to provide written informed consent
Willingness to adhere to study procedures
Willingness to provide locator information for follow-up
Exclusion Criteria for women enrolled:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Stringer, MD, FACOG | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korle Bu Teaching Hospital, | Accra | Ghana | ||||
| Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38167483 | Derived | Walter JR, Xu S, Rogers JA. From lab to life: how wearable devices can improve health equity. Nat Commun. 2024 Jan 2;15(1):123. doi: 10.1038/s41467-023-44634-9. |
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Deidentified individual data that support the study results will be shared within 6 months of the publication of primary results. As this is a multi-country study with data sharing governed by multiple research ethics and governmental oversight entities, data sharing will be subject to each country providing individual approval in accordance with its own local regulatory requirements.
Deidentified individual data that supports the study results will be shared within 6 months of the publication of primary results.
See plan description
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Belagavi |
| Karnataka |
| India |
| Fakir Mohan Medical College and Hospital | Balasore | Odisha | India |
| Women and Newborn Hospital at University Teaching Hospital | Lusaka | Zambia |