Maternal HealthNCT06095960
Telehealth Multi-Component Optional Model (MOM) Study
A study testing Telehealth MOM in people with Maternal Health, run by University of Arkansas at 6 sites in United States.
Trial summary
The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health
- What is being tested?
- Telehealth MOM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Feb 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between 16-35 weeks gestation
- Age 18-44 years
- Ability to speak English, Spanish, or Marshallese
- Participants may have either a vaginal birth or cesarean section birth
Who cannot join
- Type 1 diabetes on an insulin pump followed closely by endocrinology
- Uncontrolled Type 2 diabetes
- End stage renal disease followed closely by nephrology
- ICU admission at any point during pregnancy or delivery hospitalization
- Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
- Incarceration
Show all 16Show fewer
- Mental disability limiting decision-making capacity
- Uncontrolled chronic hypertension
- HELLP syndrome during pregnancy
- Sickle cell disease
- Maternal heart condition or heart disease
- Opioid use disorder
- Lupus
- Thrombophilia or blood clots
- Need for blood transfusion during delivery hospitalization
- Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
UAMS El Dorado FMC
El Dorado, Arkansas, 71730
Kenny Halloran, KHalloran@uams.edu
- Recruiting
UAMS Fayetteville FMC
Fayetteville, Arkansas, 72703
Kenny Halloran, KHalloran@uams.edu
- Recruiting
UAMS Fort Smith FMC
Fort Smith, Arkansas, 72901
Kenny Halloran, KHalloran@uams.edu
- Not yet recruiting
UAMS Jonesboro FMC
Jonesboro, Arkansas, 72401
Kenny Halloran, KHalloran@uams.edu
- Recruiting
UAMS Health Women's Center
Little Rock, Arkansas, 72205
Kenny Halloran, KHalloran@uams.edu
- Recruiting
UAMS Springdale FMC
Springdale, Arkansas, 72764
Kenny Halloran, KHalloran@uams.edu
About this study
Official title: Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women
The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.
- Conditions
- Maternal Health
- Being tested
- Telehealth MOM, Enhanced Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth MOMBehavioural
Patients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit.
Enhanced Standard of CareOther
Patients will receive enhanced standard of care which includes: education on symptoms and when to call their healthcare provider, comprehensive 6-week post-partum visit, and any healthcare deemed necessary by providers.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth MOM | Experimental | Telehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum. Receives: Behavioral: Telehealth MOM |
| Enhanced Standard of Care | Active comparator | Enhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers. Receives: Other: Enhanced Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of post-partum 6-week comprehensive visit
Binary measure (yes/no) of visit completion
Measured: Baseline to 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start12 Feb 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jennifer Callaghan-Koru, PhD, Principal investigator, University of ArkansasPearl McElfish, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095960
- Sponsor's protocol ID
- 276311
- Status last verified
- Feb 2026
- First submitted
- 17 Oct 2023
- Last updated
- 5 Feb 2026
- Results posted
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women
- ClinicalTrials.gov ID
- NCT06095960
- Acronym / sponsor ID
- 276311
- Conditions
- Maternal Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Oct 2023 (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.
The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth MOM | Experimental | Behavioral: Telehealth MOMTelehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum. |
| Enhanced Standard of Care | Active comparator | Other: Enhanced Standard of CareEnhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women between 16-35 weeks gestation
- Age 18-44 years
- Ability to speak English, Spanish, or Marshallese
- Participants may have either a vaginal birth or cesarean section birth
Key exclusion criteria (16 listed)
- Type 1 diabetes on an insulin pump followed closely by endocrinology
- Uncontrolled Type 2 diabetes
- End stage renal disease followed closely by nephrology
- ICU admission at any point during pregnancy or delivery hospitalization
- Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
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 |
|---|---|---|
| Telehealth MOMPatients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit. | Behavioural | Telehealth MOM |
| Enhanced Standard of CarePatients will receive enhanced standard of care which includes: education on symptoms and when to call their healthcare provider, comprehensive 6-week post-partum visit, and any healthcare deemed necessary by providers. | Other | Enhanced Standard of Care |
Primary outcome
Completion of post-partum 6-week comprehensive visit
Time frame: Baseline to 6 weeks post-partum
Binary measure (yes/no) of visit completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- 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.
Jennifer Callaghan-Koru, PhD principal investigator
University of Arkansas
Pearl McElfish, PhD principal investigator
University of Arkansas
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth MOM in people with Maternal Health, run by University of Arkansas at 6 sites 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 4 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Rowland, MA (4797138661, mbrowland@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of post-partum 6-week comprehensive visit (time frame: Baseline to 6 weeks post-partum). 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 5 Feb 2026.