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NCT Number: NCT07293728

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location contact

Julia Tasset

PRINCIPAL_INVESTIGATOR

Women's Health Research Unit

CONTACT

[email protected]

503-494-3666

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norethindrone 0.35 MG

Drug

1 tablet (0.35 mg) once daily, taken at the same time each day between hospital discharge following delivery until 6 weeks postpartum.

Drospirenone

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. Antihypertensive Medications

    Time frame: Collected weekly for the 6 weeks following delivery.

    The proportion of participants requiring up titration or new initiation of antihypertensive medications after discharge from the hospital. Measured by weekly survey.

  2. Follow-Up Visits

    Time frame: Assessed weekly between delivery and 6 weeks postpartum.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Women's Health Research Unit Department of OB/Gyn

CONTACT

[email protected]

503-494-3666

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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