Recruiting

Observational Study

Sponsor:

Ochsner Health System

Code:

NCT06920563

Conditions

Pre-Eclampsia; Complicating Pregnancy

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Video

Text Reminder

Blood pressure threshold

Study Details

Brief summary:

The goal of this clinical trial is to learn if patient education and regular text reminders are a feasible intervention to engage patients and reduce post partum hypertension. The main questions it aims to answer are:

Is a structured postpartum remote blood pressure monitoring intervention with education and individualized medication initiation/adjustment follow-up by televisit feasible? Does a structured program reduce the occurrence of postpartum hypertension, ED visits, hospital readmissions, and adverse outcomes?

Participants will:

View an educational video on HDP post-delivery Receive 1-2 times daily text messages for 6 weeks postpartum Have their blood pressure medications adjusted to lower targets post partum

Conditions

Pre-Eclampsia; Complicating Pregnancy

Gestational Hypertension

Study ID

NCT06920563

Start date

Mar 17, 2025

Status verified date

Apr, 2025

Completion date

Oct 16, 2026

Anticipated

Primary completion date

Oct 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age of at least 18 years.
2. Postpartum status.
3. Experience new-onset hypertension during pregnancy.
4. Enrollment in Connected MOM.
5. Ability to provide informed consent.
6. Establish medical care within the Ochsner System to facilitate data collection.

Exclusion Criteria:

1. History of preeclampsia or gestational hypertension during previous pregnancy
2. History of chronic hypertension
3. History of coronary artery disease (myocardial infarction, coronary stent placement, coronary artery bypass grafting, spontaneous coronary artery dissection)
4. History of ischemic CVA
5. History of Congestive heart failure
6. Renal dysfunction
7. Liver dysfunction
8. Left ventricular dysfunction
9. Congenital heart disease
10. Still birth at delivery

Study Design

Enrollment

296 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

This group will watch an education video, receive text message updates, and have their blood pressure medications titrated to a lower BP goal.

no intervention: Control

This group will receive usual post partum care from their obstetrician

Interventions

Video

Those in the intervention arm will watch a short educational video.

Text Reminder

Those in the intervention group will receive regular text message reminders to check their blood pressures

Blood pressure threshold

Those in the intervention group will have a lower blood pressure threshold to titrate their BP medications towards

Primary outcome measure

  • Engagement [ Time Frame: 6 weeks ]
  • Acceptability [ Time Frame: 6 weeks ]
  • Duration of Participation [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Salima Qamruddin, MD

+1 (504) 842-4135salima.qamruddin@ochsner.org

Locations

Ochsner Baptist

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Ken Bode

+1 (504) 842-1936ken.bode@ochsner.org

Principal Investigator:

Salima Qamruddin

More Information

Sponsor

Ochsner Health System

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2025-04-09.