NCT07293728

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Hypertension
• Preeclampsia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study