Hydrochlorothiazide for Postpartum Hypertension

Recruiting at 2 trial locations

Overseen By Megan C Shepherd, M.D.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Antihypertensives

Disqualifiers: Advanced renal failure, Anuria, Hypersensitivity, Lactose intolerance, Diabetes

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

612 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hydrochlorothiazide, a common blood pressure medication, can prevent or reduce high blood pressure issues after childbirth, particularly related to pregnancy conditions like preeclampsia or gestational hypertension. Participants will receive either the medication or a placebo for comparison. The trial seeks individuals who experienced high blood pressure or preeclampsia during pregnancy. Those who do not require ongoing high blood pressure treatment and do not have certain medical conditions, such as pre-existing diabetes or severe lactose intolerance, may be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently on antihypertensive therapy, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hydrochlorothiazide, a common treatment for high blood pressure, is generally safe. In studies, new mothers taking 50 mg daily tolerated the medication well. Some may experience mild side effects, but serious problems are rare.

The FDA's approval of hydrochlorothiazide for high blood pressure further supports its safety. This trial will specifically examine its use for high blood pressure after childbirth, aiming to prevent conditions like preeclampsia. Overall, evidence suggests that hydrochlorothiazide is a safe choice for managing blood pressure in new mothers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postpartum hypertension?

Unlike the standard treatments for postpartum hypertension, which often include medications like labetalol, nifedipine, or methyldopa, hydrochlorothiazide offers a unique approach by using a diuretic to help the body eliminate excess fluid. This can potentially reduce blood pressure more effectively in some women after childbirth. Researchers are excited about hydrochlorothiazide because it may work faster than other medications, offering relief within days rather than weeks. This rapid action, combined with its different mechanism, makes it a promising option for managing postpartum hypertension.

What evidence suggests that Hydrochlorothiazide might be an effective treatment for postpartum hypertension?

Research has shown that hydrochlorothiazide, a medication that helps the body eliminate excess fluid, may aid in managing high blood pressure after childbirth. In this trial, some participants will receive hydrochlorothiazide, which studies have found lowers blood pressure more effectively than not using it. This suggests it might help prevent high blood pressure from persisting after childbirth. Although more research is needed, early results indicate that taking hydrochlorothiazide soon after delivery could reduce the risk of developing or returning to conditions like preeclampsia or gestational hypertension. Overall, it appears to be a promising option for managing blood pressure issues after childbirth. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin Bush, M.D.

Principal Investigator

UTMB

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with high blood pressure or preeclampsia during or after pregnancy.

Exclusion Criteria

I had diabetes before becoming pregnant.

I am on medication for high blood pressure.

You are unable to digest lactose, a sugar found in milk and dairy products.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Hydrochlorothiazide 50 mg or placebo once daily for fourteen days postpartum

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission rates and need for additional antihypertensive therapy

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hydrochlorothiazide
• Placebo Tablet

Trial Overview 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.

How Is the Trial Designed?

Group I: Hydrochlorothiazide 50mg Tablet Active Control 1 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 Tablet Placebo Group 1 Intervention

Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum

Hydrochlorothiazide is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Hydrochlorothiazide for:

• Edema
• Hypertension
• Nephrotic syndrome
• Nephritic syndrome
• Gouty arthritis
• Calcium nephrolithiasis

Approved in European Union as Hydrochlorothiazide for:

• Essential hypertension
• Oedema

Approved in Canada as Hydrochlorothiazide for:

• Mild to moderate hypertension
• Edema

Approved in Japan as Hydrochlorothiazide for:

• Hypertension
• Edema

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Published Research Related to This Trial

A systematic review of 39 studies involving 2901 postnatal women with hypertensive disorders of pregnancy found that while calcium-channel blockers, vasodilators, and beta-blockers can lower blood pressure postpartum, there is insufficient evidence to recommend any specific pharmacological intervention due to variability in effectiveness.

Uterine curettage was shown to significantly reduce blood pressure in the first 48 hours postpartum compared to standard care, but safety data was limited, preventing a strong recommendation for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertensive disorders of pregnancy: a systematic review. Cairns, AE., Pealing, L., Duffy, JMN., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11667308/

Oral antihypertensive agents and diuretics in the management ... We aimed to investigate which antihypertensive agent results in optimal treatment (both effectiveness and safety) of postpartum hypertension.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Data from the United States highlight favorable outcomes for postpartum HBPM compared with usual care.

3. medrxiv.org medrxiv.org/content/10.1101/2025.01.03.25319983v1.full-text

Effects of Immediate Postpartum Diuretic Treatment on ... Postpartum diuretic use was associated with lower systolic BP compared with controls and non-significant trends of lower rates of persistent HTN and postpartum ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03298802

Postpartum Management of Hypertension in Pregnancy ... 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11326966/

Clinical Outcomes Associated With a Remote Postpartum ... Remote monitoring of postpartum hypertension was associated with fewer readmissions, increased adherence to national clinical guidelines, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25001565

Feasibility of Postpartum Blood Pressure Monitoring for ... Other predefined exploratory and safety outcomes were the detection of elevated BP >140/90 mm Hg and incidence of adverse CV events, including CV hospital ...

7. nature.com nature.com/articles/s44294-025-00095-7

Advances in postpartum hypertension management One retrospective cohort study of outcomes after ambulatory BP monitoring at one year postpartum in 200 women with severe preeclampsia ...