HypertensionPhase 4NCT07293728
A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
A Phase 4 study testing Norethindrone 0.35 MG and Drospirenone in people with Hypertension and Preeclampsia, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension, Preeclampsia
- What is being tested?
- Norethindrone 0.35 MG and Drospirenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
Women's Health Research Unit, 503-494-3666, whru@ohsu.edu
Julia Tasset
About this study
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.
Read the 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
- Being tested
- Norethindrone 0.35 MG, Drospirenone
- Keywords
- Postpartum Hypertension Management
- Medical subject headings
- Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethindrone 0.35 MGDrug
1 tablet (0.35 mg) once daily, taken at the same time each day between hospital discharge following delivery until 6 weeks postpartum.
DrospirenoneDrug
1 tablet (4 mg) once daily for 24 days, followed by 4 inactive tablets. Repeated from hospital discharge following delivery until 6 weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Drospirenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured weekly for the 6 weeks following delivery.
Secondary outcomes (2)
Antihypertensive Medications
The proportion of participants requiring up titration or new initiation of antihypertensive medications after discharge from the hospital. Measured by weekly survey.
Measured: 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.
Measured: Assessed weekly between delivery and 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Tasset, Oregon Health and Science University
- Investigators
- Julia Tasset, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293728
- Sponsor's protocol ID
- STUDY00028768
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at this time to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
- ClinicalTrials.gov ID
- NCT07293728
- Acronym / sponsor ID
- STUDY00028768
- Conditions
- Hypertension, Preeclampsia
- Keywords
- Postpartum Hypertension Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum Norethindrone | Active comparator | Drug: Norethindrone 0.35 MGNorethindrone 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. |
| Postpartum Drospirenone | Experimental | Drug: DrospirenoneDrospirenone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norethindrone 0.35 MG1 tablet (0.35 mg) once daily, taken at the same time each day between hospital discharge following delivery until 6 weeks postpartum. | Drug | Postpartum Norethindrone |
| Drospirenone1 tablet (4 mg) once daily for 24 days, followed by 4 inactive tablets. Repeated from hospital discharge following delivery until 6 weeks postpartum. | Drug | Postpartum Drospirenone |
Primary outcome
Blood Pressure
Time frame: Measured weekly for the 6 weeks following delivery.
Arterial, systolic, and diastolic blood pressure will be compared between norethindrone and drospirenone users. Measured by participants at home and reported in weekly surveys.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan at this time to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Tasset principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norethindrone 0.35 MG and Drospirenone in people with Hypertension and Preeclampsia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Women's Health Research Unit Department of OB/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Measured weekly for the 6 weeks following delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.