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

Oregon Health & Science University (OHSU)

Status and phase: Begins enrollment in 4 months; Phase 4

Conditions: Hypertension; Preeclampsia

Treatments: Drug: Drospirenone; Drug: Norethindrone 0.35 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT07293728

STUDY00028768

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Postpartum Norethindrone

Active Comparator group

Description:

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.

Treatment:

Drug: Norethindrone 0.35 MG

Postpartum Drospirenone

Experimental group

Description:

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.

Treatment:

Drug: Drospirenone