ClinicalTrials.gg
RecruitingNCT07213284MI-MOM AppUpdated Jul 24, 2026

Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial

An interventional study of MI MOM App in Pregnancy, Pregnancy, Complications and Pregnancy Outcomes, sponsored by Michigan State University. Recruiting at 8 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Michigan State University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 127 studies in Pregnancy Complications with a site in United States — 39 open to participants now, 47 under way, 1 of them phase 3. Pregnancy Complications · United States.

Planned enrollment
8th of 66
500 · median 96
Started
2026
with 9 others
No phase
45 of 127
16 open now
Primary completion
2030-12
later than 41 of 46 live
Registered
117th of 127
by date

Among the 127 studies in Pregnancy Complications with a site in United States, this one is the 8th largest by planned enrollment of the 66 interventional ones that give a count, is one of 10 that started in 2026, is one of 45 with no phase, reaches primary completion later than 41 of the 46 other live ones, and was the 117th registered.

Pregnancy Complications

411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.

Browse Pregnancy Complications studies →

Open to participants now

39 of the 127 studies in Pregnancy Complications with a site in United States are open now. Recruiting first, the newest first:

33 more — sign in →

All 39 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 92 Pregnancy Complications studies recruiting now, 44 (48%) set no upper age limit and 45 (49%) stop at 75 or younger; 22 take children under 18; 35 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 127 studies in Pregnancy Complications with a site in United States, or all of them as a file.
02

Study summary

The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the "MI MOM App" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the "MI MOM App" will also have the option to contact a community health worker as needed.

Read the detailed description

The researchers aim to use a site-randomized design to determine whether the Michigan Healthy Mom (MI MOM) app will improve pregnancy health when used by pregnant women, their supporters (partners, mothers, friends, etc.), and healthcare providers, vs treatment as usual. Specifically, the researchers will test:

  1. Whether use of the MI MOM app results in improvements to self-reported app targets (e.g., reducing provider bias, increasing treatment-seeking, service connection, early warning sign awareness, and improving mental health)
  2. Whether use of the MI MOM app improved overall pregnancy and postpartum health
  3. Whether the app reduced disparities in pregnancy/postpartum health, i.e. between Black and White, rural and urban participants
03

Conditions studied

  • Pregnancy
  • Pregnancy, Complications
  • Pregnancy Outcomes

Keywords

  • Pregnancy
  • App
  • Behavioral Intervention
  • Web-based Application
  • Postpartum
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant at 20 weeks gestation or less
  • 18 years of age or older
  • Access to smartphone with text messaging and internet access
  • Speaks English
  • Enrolled in Medicaid for health insurance

Exclusion criteria

Exclusion Criteria:

  • Younger than 18 years old
  • Not pregnant or pregnant with more than 20 weeks gestation
  • No access to a smartphone with text messaging and internet access
  • Not English speaking
  • Not enrolled in Medicaid for health insurance
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    MI MOM

    Participants receive app content and text messages with information designed to improve pregnancy outcomes.

    Behavioral: MI MOM App

  • No intervention
    Treatment as Usual

    Data collection for study outcomes only

Interventions

  • BehavioralMI MOM App

    Participants enrolled in the Michigan Healthy Moms (MI MOM) app will receive initial interactive app content followed by regular text messages with information related to pregnancy health, designed to increase patient awareness of warning signs, help them with self-advocacy, and otherwise improve health in pregnancy and postpartum. They will also have online live chat (text) access to a community healthcare worker who can assist them in enrolling in services to improve their health. They will also have the option of enrolling support persons (partners, family members, close friends, etc.) in the MI MOM app to receive similar information designed to help them support the pregnant participant. Providers at intervention sites will also receive information designed to improve their awareness of techniques for preventing maternal morbidity and mortality.

06

What researchers measure

Primary outcomes

  1. Total pregnancy-associated morbidity through one year postpartum

    Total pregnancy-associated non-severe and severe maternal morbidity through 1 year postpartum. Non-severe maternal morbidity will be indexed using ICD codes taken from Medicaid records, with conditions taken from World Health Organization-identified Maternal Morbidity conditions (e.g., anemia, hypertension, depression). Severe maternal morbidity will use ICD codes identified for the 21 severe maternal morbidity indicators developed by the CDC.

    Time frame: Start of pregnancy through 1 year postpartum

  2. Pregnancy-Associated Mortality through one year postpartum

    Total pregnancy-associated mortality through 1 year postpartum as measured using a preexisting linked dataset of Medicaid claims, deaths, birth records, and Evidence-Based Practice Center (EPC) program data.

    Time frame: Start of Pregnancy through 1 year postpartum

  3. Composite Index, total number of maternal morbidity and mortality risk factors

    A composite index evaluating multiple maternal morbidity and mortality behavioral risk factors including the Tobacco, Alcohol, Prescription medication, and other Substance use Tool for substance use (TAPS); the Humiliation, Afraid, Rape, Kick questionnaire for intimate partner violence (HARK); the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Screener (GAD-7) for symptoms of depression and anxiety; patient understanding of early warning signs of pregnancy complications and appropriate responses; confidence in ability to communicate effectively with healthcare providers; help-seeking behaviors/service utilization, and prenatal care adherence. Total score on this composite index will be the number of risks on which the participant is positive at that assessment point. All risks will refer to the time since becoming pregnant (baseline) or since the last assessment point (follow-up observations) except for depression and anxiety, which refer to the past two weeks.

    Time frame: Measured at 6 weeks post-baseline, 35 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum, and 1 year postpartum.

07

Study locations

8 of 8 sites recruiting
  • Shiawasee Health Department
    Corunna, Michigan 48817, United States
    Recruiting
  • McLaren Flint OB-GYN
    Flint, Michigan 48532, United States
    Recruiting
  • Munson Gaylord OB-GYN
    Gaylord, Michigan 49735, United States
    Recruiting
  • Trinity Health OB-GYN
    Grand Rapids, Michigan 49503, United States
    Recruiting
  • MidMichigan OB-GYN
    Midland, Michigan 48640, United States
    Recruiting
  • Munson Prudenville OB-GYN
    Prudenville, Michigan 48651, United States
    Recruiting
  • MyMichigan Sault OB-GYN
    Sault Ste. Marie, Michigan 49783, United States
    Recruiting
  • Grand Traverse Women's Clinic
    Traverse City, Michigan 49684, United States
    Recruiting
08

References and documents

Publications

  • Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. Site-randomised trial of a multilevel digital intervention to reduce maternal morbidity and mortality: a study protocol. BMJ Open. 2025 Dec 21;15(12):e113340. doi: 10.1136/bmjopen-2025-113340. PubMed 41423300 ↗
  • Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. A study protocol for a site-randomized trial of a multi-level digital intervention to reduce maternal morbidity & mortality. medRxiv [Preprint]. 2025 Oct 31:2025.10.29.25339066. doi: 10.1101/2025.10.29.25339066. PubMed 41282939 ↗

Related links

Individual participant data

Plan to share: Yes — All study data that does not reveal participant identity.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: Following NICHD data and specimen hub standards.

Access criteria: Following NICHD data and specimen hub standards.

Data sharing details ↗ · dash.nichd.nih.gov

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Dec 2030, 53 months after the start.

Of 119 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 53 months is above that.

Counting every sponsor, half of 119 studies reached it within 26 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2025
First posted
Oct 8, 2025
StartActual
Jul 15, 2026
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2031
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07213284
Responsible party
Steven J. Ondersma (Professor- Tenure System, Michigan State University) — Principal investigator
First posted
Oct 8, 2025
Start date
Jul 15, 2026
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Jul 24, 2026

Study contacts

Steven J Ondersma, PhD
Contact
onders12@msu.edu
313-444-9797
Claire E Margerison, PhD
Contact
margeris@msu.edu
517-353-8623

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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