Managing postpartum hypertension with hydrochlorothiazide
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial
This study is testing if the medication hydrochlorothiazide can help new mothers prevent high blood pressure problems after giving birth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 612 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 2 sites (Austin, Texas and 1 other locations) |
| Trial ID | NCT03298802 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of hydrochlorothiazide as a prophylactic treatment to prevent the relapse of preeclampsia and gestational hypertension in postpartum women. It aims to assess its impact on readmission rates, the need for additional antihypertensive therapy, and the frequency of triage visits related to pregnancy-induced hypertension. Participants will receive either hydrochlorothiazide or a placebo to determine the drug's efficacy in managing these conditions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 50 who have been diagnosed with gestational hypertension or preeclampsia during pregnancy, labor, or postpartum.
Not a fit: Patients who are already on antihypertensive therapy at the time of screening or who plan to be discharged with oral antihypertensive medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of postpartum hypertension complications for new mothers.
How similar studies have performed: Other studies have shown promising results with similar prophylactic approaches in managing hypertension during and after pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal age ≥ 18 years and \<50 years. * Diagnosis of gestational hypertension\* or preeclampsia\^ at any time during pregnancy, labor or postpartum. * defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm Hg or greater, or both) or \^ defines as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.) Exclusion Criteria: * Subject requiring antihypertensive therapy at time of screening. * Planned discharge with oral anti-hypertensive medication. * Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides). * Subject not able to follow up postpartum. * Lactose intolerance. * Pre-gestational diabetes.
Where this trial is running
Austin, Texas and 1 other locations
- St. David's North Austin Medical Center — Austin, Texas, United States (Recruiting)
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin Bush, M.D. — Utmb
- Study coordinator: Megan C Shepherd, M.D.
- Email: mcshephe@UTMB.EDU
- Phone: 409-772-0312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.