Maternal Health CareNCT07691541
Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
A study testing Connected MOM + in people with Maternal Health Care and Hypertensive Disorder of Pregnancy, run by Tulane University at 1 site in United States.
Trial summary
Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Maternal Health Care, Hypertensive Disorder of Pregnancy
- What is being tested?
- Connected MOM +
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Oct 2029
- Phase
- Interventional
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Access to a smartphone
- Understanding of English or Spanish in oral and written discourses
- Have a participating Ochsner-employed provider
- Plan to deliver at a participating Ochsner hospital
- Reside in a zip code served by the participating clinics
Who cannot join
- Provider feels that study participation is not in patient's best interest
- Does not understand English or Spanish well enough to follow recommendations
- Plans to move from the study area served by the participating clinics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ochsner Health
New Orleans, Louisiana, 70121
Sherri Longo, MD, 504-842-4151, slongo@ochsner.org
Sherri Longo, MD
About this study
Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care
Read the detailed description
Study outcomes include: 1) To determine whether providing enhanced support and coaching to support Connected MOM use increases use among those who stand to benefit; 2) To determine whether Connected MOM and healthcare resources are more appropriately used with provision of additional support; and 3) To determine whether the enhancement of support for the Connected MOM program improves maternal and infant health outcomes.
- Being tested
- Connected MOM +
- Keywords
- maternal and infant health, prenatal care, postpartum follow-up
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected MOM +Other
Navigator support to encourage enrollment, consistent use, and postpartum follow-up in Connected MOM program
| Study group | Role | What they receive |
|---|---|---|
| Intervention - CM+ | Active comparator | Navigator support to enroll and use Connected MOM Receives: Other: Connected MOM + |
| Control - CM | No intervention | Standard protocol for offering Connected MOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful use of the intervention and control programs measured by enrollment aggregate
Aggregate enrollment in the intervention or control arms by 25 weeks of gestation relative to the total number of eligible participants. This will be measured by the total number of women participating in the Connected MOM or Connected MOM+ divided by the total number of eligible pregnant women presenting to the hospital.
Measured: 6-9 months
Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements
This is determined by measuring the systolic and diastolic blood pressure in mmHg at least once per week during pregnancy.
Measured: 6-9 months
Successful use of the intervention and control programs as determined by postpartum blood pressure measurement
This is determined by measuring at least one postpartum blood pressure measurement (systolic and diastolic) in mmHg before a postpartum visit.
Measured: 6-9 months
Adequacy of prenatal care
Adequacy of prenatal care will be measured using the Kotelchuck index, a score that assesses the adequacy of maternal health care. The score ranges from 0% to above, with higher scores indicating better maternal health care.
Measured: 6-9 months
Adverse composite maternal outcome
pre-eclampsia without severe features (~5%), pre-eclampsia with severe features (1-2%), HELLP syndrome; eclampsia (rare), preterm delivery < 37 weeks (spontaneous or indicated) (12-15%), SMM without transfusion included (around 2-3%), maternal mortality
Measured: 6-9 months
Secondary outcomes (5)
Reach
Number of patients enrolled by 25 weeks' gestation)/# of patients either eligible, order placed, onboarded, or contacted by navigator
Measured: 6-9 months
Sustainability
Number of Connected MOM enrolled pregnancies in a given year / # eligible pregnancies by geographic residence
Measured: 6-9 months
Engagement
Percent of eligible weeks with a remote BP measurement
Measured: 6-9 months
Retention
Percent of people who remain in the program to delivery and to 4-6 weeks postpartum
Measured: 6-9 months
Attendance of a postpartum visit
Attendance at at least 1 postpartum visit to compare compliance with physicians' recommendations for postpartum care between the 2 groups.
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2026
- Primary completionJul 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Health CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ochsner Health System
- Responsible party
- Sponsor
- Investigators
- Emily W Harville, PhD, Principal investigator, Tulane University Weatherhead School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691541
- Sponsor's protocol ID
- U54HD113159 (RP2)
- Other IDs
- U54HD113159
- Status last verified
- Sep 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are covered by HIPAA