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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03942536
Other study ID # FMCH-2018-27289
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date November 1, 2021

Study information

Verified date June 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 239
Est. completion date November 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota Maseno University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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