Clinical trial NCT03942536: The MOMENTUM Study (Monitoring Maternal Emergency Navigation and Triage on Mfangano
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Neonatal Care
Emergency Care
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Maseno University
First posted: 2019-05-08
Enrollment: 239
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women, and CHW volunteers OHR-EKC and MoH health facility staff

Brief summary: This is an observational cohort study that will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care.

Detailed description: Through a 12-month mixed methods, observational cohort study, investigators from Maseno University, University of Minnesota (UMN) and OHR-EKC will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care among patients seeking care at 9 health centers on Mfangano Island, as well as the preliminary impact and feasibility/acceptability of the HN approach for improving access to MNH services and shortening delays in care.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess time interval delays in access to emergency care among women and newborns who experience a critical health emergency
timeFrame: From subject enrollment through study completion, an average of 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Chas Salmen, MD
role: PRINCIPAL_INVESTIGATOR
References: