Persistent Postpartum Hypertension Pilot Trial

NCT04349124 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00104425
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Average Systolic Blood Pressure at 1 Week Postpartum

  1 week postpartum

Secondary Outcomes (11)

• Average Systolic Blood Pressure at 4 Weeks Postpartum

  4 weeks postpartum

• Average Diastolic Blood Pressure at 1 Week Postpartum

  1 week postpartum

• Average Diastolic Blood Pressure at 4 Weeks Postpartum

  4 weeks postpartum

• Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum

  1 week postpartum

• Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum

  4 weeks postpartum

Study Arms (2)

Treatment Group

OTHER

The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal.

Drug: Nifedipine Extended-Release Tablets

Control Group

NO INTERVENTION

The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (\>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal.

Interventions

Nifedipine Extended-Release Tablets DRUG

Antihypertensive

Treatment Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Antepartum diagnosis of gestational hypertension
• preeclampsia
• superimposed preeclampsia without antepartum chronic hypertension medication
• Delivery at 23 weeks or greater
• Persistent elevation in BP \>24 hours postpartum (\>140/90 mm Hg) (2 or more BP \>4 hours apart)
• years or older
• English speaking

You may not qualify if:

• Need for continuation of antepartum antihypertensive medication
• Contraindication of calcium channel blocker use
• Severe range (160/110 mm Hg) blood pressure requiring treatment \>24 hours after delivery
• Requires a 2nd oral antihypertensive medication for blood pressure control inpatient
• Acute cardiomyopathy or heart failure
• Creatinine ≥1.5
• Blood pressure \<90/60 within 24 hours of discharge

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Brenna Hughes, M.D.
• Organization: Duke University

brenna.hughes@duke.edu

919-668-0843

Study Officials

• Brenna Hughes, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment Arm vs Active Control Arm

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: August 25, 2020
• Primary Completion: February 12, 2021
• Study Completion: March 4, 2021
• Last Updated: April 3, 2023
• Results First Posted: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)