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

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy; Neonatal Care; Emergency Care
• Intervention / Treatment: Other: Focus Group Discussion

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.

• Study Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women, and CHW volunteers OHR-EKC and MoH health facility staff

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MNH Emergency Cohort; Participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency.	Other: Focus Group Discussion; At 12-month follow-up, a purposeful, convenience sample of study participants and their significant others, Community Health Workers trained as Health Navigators, and local program staff, will be invited by research staff to participate in focus group discussions to collect qualitative data on pregnancy care, experience of navigating obstetrical emergencies, financial hardships, and Health Navigation program feasibility/acceptability. Particular attention will be paid to recruiting study subjects involved in complex obstetrical emergencies, cases that involved significant delays in transfer of care, cases resulting in significant morbidity/mortality, as well as cases that involved efficient/successful care coordination, referral, and transportation.
Birth Planning cohort; Pregnant women who complete an initial Birth Plan through the HN program within Mfangano Island East and South Sub-locations.	Other: Focus Group Discussion; At 12-month follow-up, a purposeful, convenience sample of study participants and their significant others, Community Health Workers trained as Health Navigators, and local program staff, will be invited by research staff to participate in focus group discussions to collect qualitative data on pregnancy care, experience of navigating obstetrical emergencies, financial hardships, and Health Navigation program feasibility/acceptability. Particular attention will be paid to recruiting study subjects involved in complex obstetrical emergencies, cases that involved significant delays in transfer of care, cases resulting in significant morbidity/mortality, as well as cases that involved efficient/successful care coordination, referral, and transportation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Maseno University
• Investigators: Principal Investigator: Chas Salmen, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: FMCH-2018-27289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No