Hypertension, Preeclampsia
Conditions
Keywords
Postpartum Hypertension Management
Brief 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 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).
Interventions
1 tablet (0.35 mg) once daily, taken at the same time each day between hospital discharge following delivery until 6 weeks postpartum.
DRUGDrospirenone
1 tablet (4 mg) once daily for 24 days, followed by 4 inactive tablets. Repeated from hospital discharge following delivery until 6 weeks postpartum.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Antihypertensive Medications | 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. |
| Follow-Up Visits | 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. |
Countries
United States
Contacts
Primary ContactWomen's Health Research Unit Department of OB/Gyn
Outcome results
None listed