The MOMENTUM Study (Monitoring Maternal Emergency Navigation and Triage on Mfangano

Completed

• Conditions: Neonatal Care; Pregnancy; Emergency Care
• Interventions: Other: Focus Group Discussion

• Registration Number: NCT03942536
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Start: 2019-05-15
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Birth Planning cohort	Focus Group Discussion	Pregnant women who complete an initial Birth Plan through the HN program within Mfangano Island East and South Sub-locations.
MNH Emergency Cohort	Focus Group Discussion	Participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency.

Primary Outcome Measures

Name	Time	Method
Assess time interval delays in access to emergency care among women and newborns who experience a critical health emergency	From subject enrollment through study completion, an average of 12 months.	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States