NCT07209254

Brief Summary

A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Nov 2029

First Submitted

Initial submission to the registry

September 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

May 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

September 30, 2025

Last Update Submit

May 20, 2026

Conditions

Hypertension, Pregnancy Induced

Keywords

Postpartum HypertensionBlood pressure managementPreeclampsiaHypertension, pregnancy induced

Outcome Measures

Primary Outcomes (1)

  • Mean diastolic blood pressure (DBP)

    Assessed by 24-hour ambulatory blood pressure monitor (ABPM)

    12 months postpartum

Secondary Outcomes (10)

  • Blood pressure outcome: Mean systolic blood pressure (SBP)

    12 months postpartum

  • Blood pressure outcome: Mean nocturnal DBP

    12 months postpartum

  • Blood pressure outcome: Mean nocturnal SBP

    12 months postpartum

  • Blood pressure outcome: Mean DBP

    12 months postpartum

  • Chronic Hypertension

    12 months postpartum

  • +5 more secondary outcomes

Study Arms (2)

High-touch blood pressure management

EXPERIMENTAL
Other: High-touch blood pressure management

Low-touch blood pressure management

EXPERIMENTAL
Other: Low-touch blood pressure management

Interventions

High-touch blood pressure managementOTHER

Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care

High-touch blood pressure management
Low-touch blood pressure managementOTHER

10 days of text-based home blood pressure monitoring

Low-touch blood pressure management

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Delivery within 14 days
  • Diagnosis of preeclampsia or gestational hypertension with or without severe features during pregnancy or within 14 days postpartum
  • Initiation of blood pressure medication prior to hospital discharge and up to 14 days postpartum
  • English or Spanish speaking (able to read/understand consent and instructions)
  • Has phone texting capabilities

You may not qualify if:

  • Diagnosis of chronic hypertension prior to delivery (would therefore include super imposed preeclampsia)
  • Pre-existing cardiovascular disease (including prior myocardial infarction, stroke, heart failure with reduced ejection fraction, ventricular tachycardia, prior cardiac arrest, pacemaker, severe valvular heart disease, or prior cardiac surgery)
  • Chronic kidney disease (stage 3 or higher)
  • Using ≥3 BP medications at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NYU Langone Health

New York, New York, 10022, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Jennifer Lewey, MD, MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lewey, MD, MPH

CONTACT

215-662-7700Jennifer.Lewey@pennmedicine.upenn.edu

Alexis Giron, M.S

CONTACT

Alexis.Giron@Pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine (Cardiovascular Medicine)

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 6, 2025

Study Start

March 2, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

May 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations

US(3)