Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus

NCT07691541 | Not Yet Recruiting DMC

• 2 other identifiers: U54HD113159 (RP2)U54HD113159
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care

Conditions

Maternal Health Care; Hypertensive Disorder of Pregnancy

Keywords

maternal and infant health; prenatal care; postpartum follow-up

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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

  6-9 months

Secondary Outcomes (5)

• Reach

  6-9 months

• Sustainability

  6-9 months

• Engagement

  6-9 months

• Retention

  6-9 months

• Attendance of a postpartum visit

  6-9 months

Study Arms (2)

Intervention - CM+

ACTIVE COMPARATOR

Navigator support to enroll and use Connected MOM

Other: Connected MOM +

Control - CM

NO INTERVENTION

Standard protocol for offering Connected MOM

Interventions

Connected MOM + OTHER

Navigator support to encourage enrollment, consistent use, and postpartum follow-up in Connected MOM program

Intervention - CM+

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• Ochsner Health System: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Emily W Harville, PhD

  Tulane University Weatherhead School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily W Harville, PhD

CONTACT

504-988-7327; harville@tulane.edu

Sherri M Longo, MD

CONTACT

504-842-4151; slongo@ochsner.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)