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NCT Number: NCT07691541

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

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

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Key information

Conditions

Maternal Health Care Hypertensive Disorder of Pregnancy Infections Toxemia

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location contact

Sherri Longo, MD

CONTACT

[email protected]

504-842-4151

Sherri Longo, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Connected MOM +

Other

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

Primary outcomes

  1. Successful use of the intervention and control programs measured by enrollment aggregate

    Time frame: 6-9 months

    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.

  2. Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements

    Time frame: 6-9 months

    This is determined by measuring the systolic and diastolic blood pressure in mmHg at least once per week during pregnancy.

  3. Successful use of the intervention and control programs as determined by postpartum blood pressure measurement

    Time frame: 6-9 months

    This is determined by measuring at least one postpartum blood pressure measurement (systolic and diastolic) in mmHg before a postpartum visit.

  4. Adequacy of prenatal care

    Time frame: 6-9 months

    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.

  5. Adverse composite maternal outcome

    Time frame: 6-9 months

    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

Secondary outcomes

  1. Reach

    Time frame: 6-9 months

    Number of patients enrolled by 25 weeks' gestation)/# of patients either eligible, order placed, onboarded, or contacted by navigator

  2. Sustainability

    Time frame: 6-9 months

    Number of Connected MOM enrolled pregnancies in a given year / # eligible pregnancies by geographic residence

  3. Engagement

    Time frame: 6-9 months

    Percent of eligible weeks with a remote BP measurement

  4. Retention

    Time frame: 6-9 months

    Percent of people who remain in the program to delivery and to 4-6 weeks postpartum

  5. Attendance of a postpartum visit

    Time frame: 6-9 months

    Attendance at at least 1 postpartum visit to compare compliance with physicians' recommendations for postpartum care between the 2 groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily W Harville, PhD

CONTACT

[email protected]

504-988-7327

Sherri M Longo, MD

CONTACT

[email protected]

504-842-4151

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Ochsner Health System

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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