Drospirenone vs Norethindrone for High Blood Pressure After Pre-eclampsia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether drospirenone, a newer progestin-only birth control pill, can better manage high blood pressure after childbirth compared to the standard norethindrone pill. The focus is on women who experienced preeclampsia, a pregnancy condition that causes high blood pressure. Participants will be divided into two groups: one taking drospirenone and the other taking norethindrone, for six weeks post-hospitalization. This trial may suit those who gave birth at Oregon Health & Science University and are considering a progestin-only birth control pill after preeclampsia. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
What is the safety track record for these treatments?
Research has shown that drospirenone, a newer type of birth control pill, is generally well-tolerated. One study found that a birth control pill with drospirenone did not significantly affect blood pressure or heart health, suggesting it is safe to use. It might even help lower blood pressure, which could benefit those with high blood pressure after experiencing pre-eclampsia.
Norethindrone, another type of birth control pill, has been available for a long time. It is often recommended for new mothers, especially those who are breastfeeding. Norethindrone is widely used and has a strong safety record.
Both drospirenone and norethindrone have FDA approval for use as birth control, indicating they have undergone careful safety checks. However, individual reactions can vary, so discussing any concerns with a healthcare provider is important.12345Why are researchers enthusiastic about this study treatment?
Drospirenone is unique because it not only serves as a progestin-only contraceptive, like norethindrone, but also has mineralocorticoid receptor activity, which can help lower blood pressure. This dual action makes it particularly promising for postpartum individuals who have experienced hypertensive disorders, such as pre-eclampsia. Researchers are excited about drospirenone because it could offer superior blood pressure management alongside contraception, addressing both reproductive and cardiovascular health needs simultaneously.
What evidence suggests that this trial's treatments could be effective for high blood pressure after pre-eclampsia?
This trial will compare Drospirenone and Norethindrone for managing high blood pressure after pre-eclampsia. Research has shown that Drospirenone, a type of birth control pill, can slightly lower blood pressure. Specifically, doses of 2 mg and 3 mg Drospirenone reduced the systolic blood pressure by 6.1 and 4.7 points, respectively. This finding is promising for individuals with high blood pressure after pre-eclampsia, as it might offer better control than other options.
Norethindrone, another birth control pill commonly used after childbirth, effectively prevents pregnancy but does not lower blood pressure like Drospirenone. This trial evaluates Drospirenone as a potentially better choice for managing blood pressure in this context.12678Who Is on the Research Team?
Julia Tasset
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
This trial is for individuals who have had preeclampsia during pregnancy and are considering progestin-only pill contraception postpartum. They will be part of the study for 6 weeks after leaving the hospital.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either norethindrone or drospirenone for postpartum hypertension management
Follow-up
Participants are monitored for safety and effectiveness after treatment, with focus on blood pressure management
Open-label extension (optional)
Participants may continue drospirenone after the trial with guidance on obtaining prescriptions
What Are the Treatments Tested in This Trial?
Interventions
- Drospirenone
- Norethindrone
Trial Overview
The trial compares two types of birth control pills, Norethindrone (0.35 MG) and Drospirenone, to manage high blood pressure after childbirth in patients with a history of preeclampsia.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
Citations
A Randomized Feasibility Trial Comparing Drospirenone ...
Drospirenone represents a novel therapeutic option that may offer superior blood pressure outcomes in postpartum individuals with hypertensive ...
Effects of a contraceptive containing drospirenone and ...
A contraceptive containing 20 mcg of ethinyl estradiol and 3 mg of drospirenone causes no significant changes in clinical and autonomic parameters.
Hypertension in Pregnancy and Postpartum - PubMed Central
In the CHAP trial, treating mild chronic hypertension resulted in a statistically significant reduction in the primary composite outcome (odds ratio [OR], 0.82 ...
Hypertension in women
Drospirenone 2 mg and 3 mg, but not 1 mg, in combination with estradiol significantly reduced 24 h systolic BP by 6.1 mm Hg and 4.7 mm Hg, ...
Past hormonal contraceptive use and pre-eclampsia ...
Conclusions This stud revealed that there was no significant association between past hormonal contraceptive use and preeclampsia except implant which was ...
Associations of periconceptional oral contraceptive use ...
Periconceptional OC use, particularly those containing oestrogen, was associated with increased risks of pre-eclampsia, pre-term birth, low birthweight and SGA.
Appendix D: Classifications for Combined Hormonal ...
Evidence: Women with a history of high blood pressure in pregnancy who also used COCs had a higher risk for myocardial infarction and VTE than ...
Postpartum contraception: A matter of guidelines - Grandi - 2024
WHO guidelines contraindicate combined hormonal contraceptives postpartum in breastfeeding patients between 6 weeks and 6 months after delivery.
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