Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT07691541

Conditions

Maternal Health Care

Hypertensive Disorder of Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Connected MOM +

Study Details

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

Study ID

NCT07691541

Start date

Jul 1, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Intervention - CM+

Navigator support to enroll and use Connected MOM

no intervention: Control - CM

Standard protocol for offering Connected MOM

Interventions

Connected MOM +

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

Primary outcome measure

  • Successful use of the intervention and control programs measured by enrollment aggregate [ Time Frame: 6-9 months ]
  • Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements [ Time Frame: 6-9 months ]
  • Successful use of the intervention and control programs as determined by postpartum blood pressure measurement [ Time Frame: 6-9 months ]
  • Adequacy of prenatal care [ Time Frame: 6-9 months ]
  • Adverse composite maternal outcome [ Time Frame: 6-9 months ]

Central Contacts and Locations

Central contacts

Emily W Harville, PhD

504-988-7327harville@tulane.edu

Sherri M Longo, MD

504-842-4151slongo@ochsner.org

Locations

Ochsner Health

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Sherri Longo, MD

504-842-4151slongo@ochsner.org

Principal Investigator:

Sherri Longo, MD

More Information

Sponsor

Tulane University

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-09-03.