A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
NCT ID: NCT07293728
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2026-07-31
2026-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindications to drospirenone or norethindrone
* Inability to monitor blood pressure at home after discharge
* Inability to complete follow-up surveys by email in English
18 Years
FEMALE
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Julia Tasset
Principal Investigator
Principal Investigators
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Julia Tasset
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Women's Health Research Unit Department of OB/Gyn
Role: CONTACT
Phone: 503-494-3666
Email: [email protected]
Facility Contacts
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Women's Health Research Unit
Role: primary
Other Identifiers
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STUDY00028768
Identifier Type: -
Identifier Source: org_study_id