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

NCT03942536 | Completed

• 1 other identifier: FMCH-2018-27289
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy; Neonatal Care; Emergency Care

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

MNH Emergency Cohort

Participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency.

Other: Focus Group Discussion

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

Interventions

Focus Group Discussion OTHER

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; MNH Emergency Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Research subjects must be pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Maseno University: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Chas Salmen, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: May 8, 2019
• Study Start: May 15, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)