Optimal Blood Pressure Treatment Thresholds Postpartum

NCT06069102 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY23060147
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP). The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

Conditions

Hypertension; Eclampsia; Gestational Hypertension; Cardiovascular Diseases; Toxemia; Pregnancy Complications; Vascular Diseases; Hypertension, Pregnancy Induced; Hypertension;Pre-Eclamptic; Hypertensive Disorder of Pregnancy; Pre-Eclampsia

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Eligible, Enrolled and Retained (Feasibility)

  To determine if a randomized controlled trial of tight blood pressure control (\<135/85 mmHg on home blood pressure monitoring) vs. standard of care (\<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.

  Baseline to approximately 6 months postpartum, a total of 6 months postpartum

Secondary Outcomes (12)

• Number of Participants With Anti-hypertensive Medication Use

  6 months postpartum

• Anti-hypertensive Medication Use

  6 weeks postpartum

• Mean Arterial Pressure (Efficacy)

  6 months postpartum

• Mean Arterial Pressure

  6 weeks postpartum

• Systolic Blood Pressure

  6 months postpartum

Other Outcomes (2)

• Interval Participant Retention

  6 weeks postpartum

• Participant Retention

  6 months postpartum

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.

Drug: Usual care

Intervention (Tight Blood Pressure Control) Group

EXPERIMENTAL

BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.

Drug: Tight blood pressure control

Interventions

Usual care DRUG

The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.

Usual Care Group

Tight blood pressure control DRUG

The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Also known as: Tight control

Intervention (Tight Blood Pressure Control) Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum individuals ≥18 years old
• Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
• Enrolled in remote BP management program.

You may not qualify if:

• Pre-pregnancy hypertension
• Pre-pregnancy diabetes
• Maternal cardiac disease
• Chronic kidney disease

Sponsors & Collaborators

• Alisse Hauspurg: lead

Study Sites (1)

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Toxemia; Pre-Eclampsia; Hypertension; Eclampsia; Hypertension, Pregnancy-Induced; Cardiovascular Diseases; Pregnancy Complications; Vascular Diseases

Condition Hierarchy (Ancestors)

Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Alisse Hauspurg, MD
• Organization: University of Pittsburgh, Brown University

alh242@pitt.edu, alisse_hauspurg@brown.edu

401-274-1122

Study Officials

• Alisse K Hauspurg, MD

  UPMC Magee Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Once randomization is complete, there will be no blinding of participants, care providers or investigators. Outcomes assessors will be masked to intervention arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which individuals diagnosed with HDP will be randomized to usual care or tight blood pressure control for therapeutic intent. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: November 15, 2023
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 2, 2026
• Results First Posted: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within a year after outcomes are published and no later than 3 years after the end of clinical activities.
• Access Criteria: NHLBI data repository request process

Locations

US (1)