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临床试验/NCT07293728
NCT07293728尚未招募4 期

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

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Norethindrone 0.35 MG (Drug)

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.

干预措施: Drospirenone (Drug)

结局指标

主要结局

Blood Pressure

时间窗: 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.

次要结局

  • Antihypertensive Medications(Collected weekly for the 6 weeks following delivery.)
  • Follow-Up Visits(Assessed weekly between delivery and 6 weeks postpartum.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Tasset

Principal Investigator

Oregon Health and Science University

研究点 (1)

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