A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia

NCT07293728 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00028768
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized feasibility trial in which patients admitted to Oregon Health \& Science University (OHSU) after a pregnancy complicated by preeclampsia who are considering a progestin-only pill contraception postpartum will be randomized to norethindrone or drospirenone for 6 weeks following hospital discharge.

Conditions

Hypertension; Preeclampsia

Keywords

Postpartum Hypertension Management

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Arterial, systolic, and diastolic blood pressure will be compared between norethindrone and drospirenone users. Measured by participants at home and reported in weekly surveys.

  Measured weekly for the 6 weeks following delivery.

Secondary Outcomes (2)

• Antihypertensive Medications

  Collected weekly for the 6 weeks following delivery.

• Follow-Up Visits

  Assessed weekly between delivery and 6 weeks postpartum.

Study Arms (2)

Postpartum Norethindrone

ACTIVE COMPARATOR

Norethindrone is a well-established progestin-only contraceptive that is considered standard of care for postpartum contraception, particularly in breastfeeding individuals. Norethindrone serves as the comparator arm representing the current standard practice for postpartum contraception in individuals with recent hypertensive disorders of pregnancy.

Drug: Norethindrone 0.35 MG

Postpartum Drospirenone

EXPERIMENTAL

Drospirenone is a newer progestin-only contraceptive approved by the FDA that exhibits mineralocorticoid receptor activity that has been shown to modestly lower blood pressure in addition to serve as contraception. Drospirenone represents a novel therapeutic option that may offer superior blood pressure outcomes in postpartum individuals with hypertensive disorders unlike other progestin-only contraceptives.

Drug: Drospirenone

Interventions

Norethindrone 0.35 MG DRUG

1 tablet (0.35 mg) once daily, taken at the same time each day between hospital discharge following delivery until 6 weeks postpartum.

Postpartum Norethindrone

Drospirenone DRUG

1 tablet (4 mg) once daily for 24 days, followed by 4 inactive tablets. Repeated from hospital discharge following delivery until 6 weeks postpartum.

Postpartum Drospirenone

Eligibility Criteria

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

You may qualify if:

• Admission to Oregon Health \& Science University following a birth (during the same admission)
• A diagnosis of preeclampsia or chronic hypertension with superimposed preeclampsia (with or without severe features)
• Considering use of a progestin-only pill for postpartum contraception

You may not qualify if:

• Planned use of a contraceptive method other than a progestin-only pill
• Contraindications to drospirenone or norethindrone
• Inability to monitor blood pressure at home after discharge
• Inability to complete follow-up surveys by email in English

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hypertension; Pre-Eclampsia

Interventions

Norethindrone; drospirenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Julia Tasset

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of OB/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

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: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 19, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)