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

Trial Summary

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.

What evidence supports the effectiveness of the drug Hydrochlorothiazide for treating postpartum hypertension?

Hydrochlorothiazide is commonly used to treat high blood pressure and is effective when combined with other medications to enhance blood pressure control, especially at lower doses to minimize side effects. ^{1 2 3 4 5}

Is Hydrochlorothiazide safe for postpartum hypertension?

Thiazide diuretics, like Hydrochlorothiazide, may pose a risk to the fetus by affecting blood flow to the placenta, but this is more relevant during pregnancy rather than postpartum. There is no specific safety data for Hydrochlorothiazide in postpartum hypertension, but it is generally used with caution due to potential risks. ^{6 7 8 9 10}

How does the drug Hydrochlorothiazide differ from other treatments for postpartum hypertension?

Hydrochlorothiazide is a commonly used diuretic (a drug that helps remove excess fluid from the body) for managing high blood pressure, and it is often combined with other medications to enhance its effects. While it is widely used for general hypertension, its specific use for postpartum hypertension is less common, making it a potentially novel option for this condition. ^{4 11 12 13 14}

What is the purpose of this trial?

This trial is testing whether hydrochlorothiazide can help prevent or reduce high blood pressure in women who have given birth. The medication works by making you urinate more, which helps lower blood pressure. Hydrochlorothiazide is known for its effectiveness in lowering blood pressure.

Research Team

Benjamin Bush, M.D.

Principal Investigator

UTMB

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hydrochlorothiazide is not the most useful nor versatile thiazide diuretic. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of hydrochlorothiazide on urinary calcium excretion in dent disease: an uncontrolled trial. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Perindopril/Hydrochlorothiazide Combination in Hypertensive Patients Unresponsive to Hydrochlorothiazide Alone: A Double-Blind, Multicenter Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Combination treatment with telmisartan and hydrochlorothiazide in black patients with mild to moderate hypertension. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Historical perspective of low- vs. high-dose diuretics. [2010]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Hydralazine HCl rapidly disintegrating sublingual tablets: simple dosage form of higher bioavailability and enhanced clinical efficacy for potential rapid control on hypertensive preeclampsia. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertensive disorders of pregnancy: a systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The metabolic clearance rate of dehydroisoandrosterone sulfate. III. The effect of thiazide diuretics in normal and future pre-eclamptic pregnancies. [2017]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The flipside of hydralazine in pregnancy: A systematic review and meta-analysis. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Oral combined hydrochlorothiazide and lisinopril vs nifedipine for postpartum hypertension: a comparative-effectiveness pilot randomized controlled trial. [2023]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

[The current position of hydrochlorothiazide among thiazide and thiazide-like diuretics]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Diuretics for hypertension: Hydrochlorothiazide or chlorthalidone? [2015]

13. England pubmed.ncbi.nlm.nih.gov

Comparison of thiazide-like diuretics versus thiazide-type diuretics: a meta-analysis. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Pairwise comparison of hydrochlorothiazide and chlorthalidone responses among hypertensive patients. [2023]