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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Preeclampsia
• Intervention / Treatment: Drug: Norethindrone 0.35 MG; Drug: Drospirenone

Detailed Description

In this open-label, randomized, feasibility trial, we will recruit participants admitted to OHSU after a pregnancy complicated preeclampsia (diagnosed antepartum or postpartum). All patients admitted after a birth are offered contraception as a routine part of clinical care; only prospective participants who are undecided in their birth control method or who are considering a progestin-only pill contraception will be approached for inclusion.

Participants who consent for enrollment will be randomized to norethindrone or drospirenone. Prescriptions will be filled by the OHSU research pharmacy and delivered to patients prior to discharge. Participants will then receive weekly emails to report medication adherence, home-measured blood pressures (typical standard of care for preeclampsia), and any interval changes in medication or unscheduled healthcare encounters. Follow up will continue through six weeks, consistent with typical close blood pressure monitoring for postpartum patients with preeclampsia. Participants accessing drospirenone through the study who desire to continue after conclusion will be provided with information for obtaining a prescription from their primary provider as well as manufacturer information to reduce prescription costs (as prior authorization requirements are more common with this medication).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Women's Health Research Unit Department of OB/Gyn; Phone Number: 503-494-3666; Email: whru@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
      • Contact: Women's Health Research Unit; Phone Number: 503-494-3666; Email: whru@ohsu.edu
      • Principal Investigator: Julia Tasset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Postpartum Norethindrone; 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; 1 tablet (0.35 mg) once daily, taken at the same time each day between hospital discharge following delivery until 6 weeks postpartum.
Experimental: Postpartum Drospirenone; 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; 1 tablet (4 mg) once daily for 24 days, followed by 4 inactive tablets. Repeated from hospital discharge following delivery until 6 weeks postpartum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antihypertensive Medications	The proportion of participants requiring up titration or new initiation of antihypertensive medications after discharge from the hospital. Measured by weekly survey.	Collected weekly for the 6 weeks following delivery.
Follow-Up Visits	The number of participants requiring unscheduled in-person assessment of blood pressure concerns or readmission to the hospital relating to blood pressure concerns. Will be measured using weekly participant surveys.	Assessed weekly between delivery and 6 weeks postpartum.

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Julia Tasset, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postpartum Hypertension Management
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Hypertension; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Norpregnenes; Norpregnanes; Norsteroids; Norethindrone; drospirenone
• Other Study ID Numbers: STUDY00028768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan at this time to share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No