A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Norethindrone 0.35 MG, Drospirenone.
- Who it may be relevant to
- Registry conditions: Hypertension, Preeclampsia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- 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.
Primary outcome measures
- Blood Pressure [Time frame: Measured weekly for the 6 weeks following delivery.]
Secondary outcome measures (2)
- Antihypertensive Medications [Time frame: Collected weekly for the 6 weeks following delivery.]
- Follow-Up Visits [Time frame: Assessed weekly between delivery and 6 weeks postpartum.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT07293728 · STUDY00028768