PregnancyMOMENTUMNCT03942536
The MOMENTUM Study (Monitoring Maternal Emergency Navigation and Triage on Mfangano
An observational study of Pregnancy and Neonatal Care, run by University of Minnesota at 1 site in United States.
Trial summary
This is an observational cohort study that will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Neonatal Care, Emergency Care
- What is being tested?
- Focus Group Discussion
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women, and CHW volunteers OHR-EKC and MoH health facility staff
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
This is an observational cohort study that will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care.
Read the 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.
- Conditions
- Pregnancy, Neonatal Care, Emergency Care
- Being tested
- Focus Group Discussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Group DiscussionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MNH Emergency Cohort | Participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency. Receives: 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. Receives: Other: Focus Group Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From subject enrollment through study completion, an average of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start15 May 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Maseno University
- Responsible party
- Sponsor
- Investigators
- Chas Salmen, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942536
- Sponsor's protocol ID
- FMCH-2018-27289
- Acronym
- MOMENTUM
- Status last verified
- Jun 2022
- First submitted
- 14 Jan 2019
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03942536
- Acronym / sponsor ID
- MOMENTUM / FMCH-2018-27289
- Conditions
- Pregnancy, Neonatal Care, Emergency Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Maseno University
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNH Emergency Cohort | – | Other: Focus Group DiscussionParticipants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency. |
| Birth Planning cohort | – | Other: Focus Group DiscussionPregnant women who complete an initial Birth Plan through the HN program within Mfangano Island East and South Sub-locations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women, and CHW volunteers OHR-EKC and MoH health facility staff
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus Group DiscussionAt 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. | Other | Birth Planning cohort, MNH Emergency Cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chas Salmen, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Neonatal Care, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.