Birth OutcomesLABORNCT04102644
Limiting Adverse Birth Outcomes in Resource-Limited Settings
An observational study of Birth Outcomes and Labor and Delivery, run by University of North Carolina, Chapel Hill at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Birth Outcomes, Labor and Delivery, Respiratory Infection
- What is being tested?
- Observation
- How many people
- 12,020 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 31 Oct 2019to 20 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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*
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
India2 sites
Fakir Mohan Medical College and Hospital
Balasore, Odisha
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research
Belagavi, Karnataka
About this study
Official title: Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study
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.
Read the detailed 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.
- Conditions
- Birth Outcomes, Labor and Delivery, Respiratory Infection
- Being tested
- Observation
- Keywords
- Labor and Delivery, Childbirth in limited resource setting
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs) Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: enrollment - 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start31 Oct 2019
- Primary completion8 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth OutcomesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Jeff Stringer, MD, FACOG, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102644
- Sponsor's protocol ID
- 19-0765
- Other IDs
- Z 31902
- Acronym
- LABOR
- Status last verified
- Feb 2022
- First submitted
- 23 Sep 2019
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38167483
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study
- ClinicalTrials.gov ID
- NCT04102644
- Acronym / sponsor ID
- LABOR / 19-0765
- Conditions
- Birth Outcomes, Labor and Delivery, Respiratory Infection
- Keywords
- Labor and Delivery, Childbirth in limited resource setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,020 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: ObservationUp to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationDocumentation of course and outcome of hospitalization, labor, delivery, and postpartum period | Other | Pregnant Women |
Primary outcome
Number of cases of maternal death or severe morbidity
Time frame: enrollment - 42 days postpartum
Maternal composite: The combined number of maternal death or incident severe morbidity arising from hemorrhage, hypertension, or infection
Number of cases of neonatal death or severe morbidity
Time frame: enrollment - 42 days postpartum
Fetal/Neonatal Composite: The combined number of Intrapartum stillbirths, neonatal deaths, neonatal encephalopathy, or neonatal sepsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 38167483Walter 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Stringer, MD, FACOG principal investigator
University of North Carolina, Chapel Hill
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Outcomes and Labor and Delivery, run by University of North Carolina, Chapel Hill at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, Ghana, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of maternal death or severe morbidity (time frame: enrollment - 42 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.