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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03942536
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Maseno University
Information provided by (Responsible Party):
University of Minnesota

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

Condition or disease Intervention/treatment
Pregnancy Neonatal Care Emergency Care 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Assess time interval delays in access to emergency care among women and newborns who experience a critical health emergency [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Research subjects must be pregnant
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women, and CHW volunteers OHR-EKC and MoH health facility staff
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942536


Contacts
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Contact: Chas Salmen, MD (612) 302-8200 salme048@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Chas Salman, MD    612-302-8200    salme048@umn.edu   
Sponsors and Collaborators
University of Minnesota
Maseno University
Investigators
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Principal Investigator: Chas Salmen, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03942536    
Other Study ID Numbers: MOMENTUM
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes