Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

NCT05049616 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-21-0476
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). Both medications are part of our usual care for high blood pressure after delivery.

Conditions

Hypertension in Pregnancy; Postpartum Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Stage 2 Hypertension

  Stage 2 hypertension at day 7-10 after delivery (defined as SBP ≥ 140 and/or DBP ≥ 90 mmHg) or admission to the hospital for blood pressure control prior to day 10. Primary outcome will be calculated as the average BP reading for day 7-10 after delivery.

  7-10 after delivery

Secondary Outcomes (20)

• Number of Participants With Severe Postpartum Hypertension

  7-10 after delivery

• Number of Participants Who Received Additional Antihypertensive During Admission

  7-10 days postpartum

• Postpartum Length of Stay

  up to 30 days after delivery

• Postpartum Readmission

  up to 30 days after delivery

• Time to Blood Pressure Control

  10 days

Study Arms (2)

Hctz/Lisinopril

EXPERIMENTAL

Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)

Drug: ACE Inhibitors and Diuretics

Extended release nifedipine

ACTIVE COMPARATOR

calcium channel blocker (Nifedipine

Drug: NIFEdipine ER

Interventions

ACE Inhibitors and Diuretics DRUG

Hctz/Lisinopril (brand name: Zestoretic)

Hctz/Lisinopril

NIFEdipine ER DRUG

Extended release nifedipine

Extended release nifedipine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum women at ≥ 18 years of age
• Postpartum diagnosis of persistent hypertension (2 measurements of Systolic BP ≥150 and/or diastolic BP ≥ 100 or systolic BP ≥140 and/or diastolic BP ≥ 90 for people with diabetes) requiring an oral medication based on the ACOG criteria or
• Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood pressure medication in the postpartum
• Chronic hypertension requiring blood pressure medication postpartum

You may not qualify if:

• Urine output \< 30 cc/h prior to screening for eligibility
• Creatinine \> 1.4 during current admission
• End-stage renal disease
• Hypersensitivity to ACE inhibitors or sulfa drugs
• Idiopathic/hereditary angioedema
• Hyperkalemia (serum potassium \>5 mEq/L) during current admission
• Pulmonary edema

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Angiotensin-Converting Enzyme Inhibitors; Diuretics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Natriuretic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Michal Fishel Bartal, MD
• Organization: The University of Texas Health Science Center at Houston

michal.f.bartal@uth.tmc.edu

(713) 500-6421

Study Officials

• Michal Fishel Bartal, MD

  UT Health Science Center

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized control trial

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 20, 2021
• Study Start: October 18, 2021
• Primary Completion: June 26, 2022
• Study Completion: September 1, 2023
• Last Updated: November 10, 2025
• Results First Posted: August 14, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)