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Diuretic

Hydrochlorothiazide for Postpartum Hypertension

Phase 3
Recruiting
Led By Antonio Saad, M.D.
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 defined 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-6 weeks postpartum
Awards & highlights

Study Summary

This trial found that postpartum prophylactic administration of hydrochlorothiazide (HCTZ) may be effective in preventing relapse of preeclampsia or gestational hypertension.

Who is the study for?
This trial is for women aged 18-50 who had high blood pressure or preeclampsia during pregnancy. They must not need blood pressure meds at screening, can't be discharged with such meds, and shouldn't have kidney failure, sulfonamide allergy, pre-gestational diabetes, lactose intolerance or issues that prevent follow-up.Check my eligibility
What is being tested?
The study tests if Hydrochlorothiazide (HCTZ), a water pill, can prevent high blood pressure problems after birth compared to a placebo. Women will randomly receive either HCTZ or an inactive tablet to see which is better at preventing relapses of hypertension or preeclampsia postpartum.See study design
What are the potential side effects?
Hydrochlorothiazide may cause dehydration, low potassium levels leading to muscle weakness and abnormal heart rhythms, light sensitivity resulting in sunburns more easily than usual, dizziness upon standing up too fast due to lowered blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 to 49.
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I have been diagnosed with high blood pressure or preeclampsia during or after pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-6 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 weeks postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Need for additional antihypertensive therapy
Rate of readmission and/or triage visits
Secondary outcome measures
Adverse Events
Elevation of blood pressure >150/90
Length of hospital stay
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Hydrochlorothiazide 50mg TabletActive Control1 Intervention
Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
Group II: Placebo TabletPlacebo Group1 Intervention
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
244 Previous Clinical Trials
56,140 Total Patients Enrolled
9 Trials studying Hypertension
5,319 Patients Enrolled for Hypertension
Antonio Saad, M.D.Principal InvestigatorUTMB
1 Previous Clinical Trials
3,374 Total Patients Enrolled
Benjamin Bush, M.D.Principal InvestigatorUTMB
1 Previous Clinical Trials
3,374 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are enrolled in this research project?

"That is correct. The listing on clinicaltrials.gov confirms that this study, which was first advertised on November 21st 2017, is still recruiting patients. They are looking for 612 people to participate at 3 different locations."

Answered by AI

What are some of the dangers associated with taking Hydrochlorothiazide 50mg Tablet?

"Hydrochlorothiazide 50mg Tablet is classified as a Phase 3 drug, meaning that there is both efficacy and safety data available. Our team has rated its safety as a 3 out of 3."

Answered by AI

Are any slots still available for participants in this trial?

"Indeed, the clinical trial is still open and recruiting patients. According to the information on clinicaltrials.gov, the study was first posted on 11/21/2017, with the most recent update being made 8/18/2022. They are looking for 612 participants total, which will be recruited from 3 sites."

Answered by AI

What is the goal of this clinical trial?

"The primary outcome of this study, which will take place in the 6 weeks post-partum, is the Need for additional antihypertensive therapy. Additionally, we will measure Use of resources (hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures), Total Additional doses of anti-hypertensive therapy (addition of total doses that patient received in the postpartum period), and Length of hospital stay (days that patient required to be in-house in the postpartum period) as secondary outcomes."

Answered by AI

Can I join this clinical trial?

"The ideal candidate for this study is a woman aged 18-50 who has been diagnosed with pre-eclampsia. A total of 612 participants are needed."

Answered by AI

What are some common reasons why people take Hydrochlorothiazide 50mg Tablets?

"Hydrochlorothiazide 50mg Tablet is often used to counteract sodium retention, but it can also be helpful in managing edema, when other therapies have been ineffective, and for patients who do not respond well to blood pressure medication."

Answered by AI

Are there other research papers that focus on Hydrochlorothiazide 50mg Tablet?

"There are currently 12 ongoing clinical trials studying the effects of Hydrochlorothiazide 50mg Tablets. 5 of those trials are in their third and final phase. Most of the trial locations for this medication are centred around Kansas City, Kansas; though, there are 80 total locations running these studies."

Answered by AI

If a septuagenarian meets the other requirements, are they eligible for this research project?

"The parameters for this study only allow patients aged 18 to 50. However, there are 66 other clinical trials for minors and 739 for seniors."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas Medical Branch
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to educate and help my self to feel better, have more energy, I also have a strong desire to help others , so I feel that a clinical trail or trails would be a good way for me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
2017. "Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03298802.
All > Preeclampsia > High Blood Pressure
~23 spots leftby Aug 2024
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