Pregnancy Clinical Trial
— MOMENTUMOfficial title:
The MOMENTUM Study (Monitoring Maternal Emergency Navigation and Triage on Mfangano) : A 12-month Community-based Cohort Study to Evaluate Delays in Access to Maternal and Newborn Emergency Care in Western Kenya
Verified date | June 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational cohort study that will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care.
Status | Completed |
Enrollment | 239 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Overall Inclusion Criteria: - Must be =18 years of age as of the date of study eligibility, or qualify as an emancipated minor (ie: person aged less than 18 years who was married, pregnant, or a parent, consistent with Government of Kenya guidelines and previous research such as Kenya AIDS Indicator Survey-KAIS) - Must be conversant with one of the commonly spoken languages within the study area (i.e. DhoLuo, Swahili or English; prior experience indicates that this represents >99% of the adult population) - Must be willing to share confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system. - Must have the ability to provide informed consent. Emergency Cohort-Specific Criteria: - Participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency, or appropriate family member in the case that patient is not able to participate in interview due to death or illness or other circumstance. Birth Planning Cohort-Specific Criteria: - All pregnant women who register a birth plan through the Health Navigation Birth Planning service will be eligible to enroll in the Birth Planning Cohort Focus Group Cohort-Specific Criteria: - All participants from the emergency cohort and the birth planning cohort will be eligible, as well as CHW volunteers, and OHR-EKC and MoH health facility staff Exclusion Criteria: - Individuals under the age of 18 and who do not qualify as emancipated minors - Individuals who do not speak either English, Dholuo or Swahili - Individuals who are not comfortable sharing confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system. |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | Maseno University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess time interval delays in access to emergency care among women and newborns who experience a critical health emergency | Quantify interval time delays in accessing emergency MNH care among women and newborns who experience a critical pregnancy-related, obstetrical, or neonatal health emergency on Mfangano Island Division. | From subject enrollment through study completion, an average of 12 months. |
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