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Completed

NCT Number: NCT05049616

Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). Both medications are part of our usual care for high blood pressure after delivery.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Health Science Center

Houston, Texas, 77030, United States

About this study

In individuals with preeclampsia, persistent hypertension and edema result in part from the mobilization of up to 8 liters of fluid and sodium from the extravascular to intravascular space. The increased urinary sodium excretion on days 3-5 postpartum likely results from higher atrial natriuretic peptide concentrations in plasma and activation of the renin-angiotensin-aldosterone system. Adding diuretics for postpartum hypertension has been associated with better blood pressure control in some of the studies.

  • CVD is the leading cause for mortality worldwide.
  • Primary prevention is more effective than treating CVD.
  • Pregnancy is often the 1st adult engagement with the healthcare system.
  • Preeclampsia is a risk factor for long term CVD, even after controlling for mutual risk factors.
  • CVD is the leading cause for pregnancy related mortality.
  • There is no good data regarding the optimal medications to control blood pressure after delivery.
  • ACE inhibitors play an important role in controlling blood pressure outside of pregnancy and there is extensive evidence to support their cardioprotective effects.
  • The optimal use of diuretics in the postpartum in patients with preeclampsia, require further study and clarification to augment current management schemes.

Hypothesis: that in postpartum women with hypertensive disorders, oral combined Hydrochlorothiazide/Lisinopril will reduce postpartum hypertension at 7 days after delivery compared to usual care with calcium channel blockers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postpartum women at ≥ 18 years of age
  • Postpartum diagnosis of persistent hypertension (2 measurements of Systolic BP ≥150 and/or diastolic BP ≥ 100 or systolic BP ≥140 and/or diastolic BP ≥ 90 for people with diabetes) requiring an oral medication based on the ACOG criteria or
  • Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood pressure medication in the postpartum
  • Chronic hypertension requiring blood pressure medication postpartum

Exclusion criteria

  • Urine output < 30 cc/h prior to screening for eligibility
  • Creatinine > 1.4 during current admission
  • End-stage renal disease
  • Hypersensitivity to ACE inhibitors or sulfa drugs
  • Idiopathic/hereditary angioedema
  • Hyperkalemia (serum potassium >5 mEq/L) during current admission
  • Pulmonary edema

Treatment and study plan

ACE Inhibitors and Diuretics

Drug

Hctz/Lisinopril (brand name: Zestoretic)

NIFEdipine ER

Drug

Extended release nifedipine

Primary outcomes

  1. Number of Participants With Stage 2 Hypertension

    Time frame: 7-10 after delivery

    Stage 2 hypertension at day 7-10 after delivery (defined as SBP ≥ 140 and/or DBP ≥ 90 mmHg) or admission to the hospital for blood pressure control prior to day 10.

    Primary outcome will be calculated as the average BP reading for day 7-10 after delivery.

Secondary outcomes

  1. Number of Participants With Severe Postpartum Hypertension

    Time frame: 7-10 after delivery

    severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart)

  2. Number of Participants Who Received Additional Antihypertensive During Admission

    Time frame: 7-10 days postpartum

    number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.

  3. Postpartum Length of Stay

    Time frame: up to 30 days after delivery

    time spent in hospital following delivery

  4. Postpartum Readmission

    Time frame: up to 30 days after delivery

    occurrence of returning to hospital for admission postpartum

  5. Time to Blood Pressure Control

    Time frame: 10 days

    The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100).

  6. Incidence of Persistent Postpartum Hypertension

    Time frame: 6 weeks postpartum

    Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg).

  7. Occurrence of Proteinuria

    Time frame: 7-10 days, and 6 weeks postpartum

    Proteinuria is measured by urine protein creatinine ratio

  8. Presense of Labs Abnormality

    Time frame: 7-10 days, and 6 weeks postpartum

    Labs abnormality including hyperkalemia or creatinine increase

  9. Compliance With Medications

    Time frame: at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth

    Compliance with medications. The patient will be asked to bring their medication bottle with them and the compliance will be measured by counting pills at each postpartum visit.

  10. Time to Control Blood Pressure

    Time frame: 3 month-1 year

    Blood pressure at 3 month, 6 month, 9 month, 1 year after delivery and need for BP medications. Definition of controlled blood pressure is (SBP < 140 and/or DBP < 90 mmHg). This will be assessed by telephone encounter with the patient

  11. Number of Patients Receiving Primary Care With BP Measurement

    Time frame: 1 year postpartum

    Number of patients receiving primary care with BP measurement at 1 year

  12. Postpartum Complications- Number of Participants With ICU Admission

    Time frame: 10 days postpartum

    Need for ICU admission

  13. Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome

    Time frame: 10 days postpartum

    Hemolysis, elevated liver enzymes, low platelet count: HELLP

  14. Postpartum Complications- Number of Participants With Eclampsia

    Time frame: 10 days postpartum

    Eclampsia, which is considered a complication of severe preeclampsia, is commonly defined as new onset of grand mal seizure activity and/or unexplained coma during pregnancy or postpartum in a woman with signs or symptoms of preeclampsia.

  15. Postpartum Complications- Number of Participants With Stroke

    Time frame: 10 days postpartum

    Stroke

  16. Postpartum Complications- Number of Participants With Renal Failure

    Time frame: 10 days postpartum

    Renal failure

  17. Postpartum Complications- Number of Participants With Pulmonary Edema

    Time frame: 10 days postpartum

    Pulmonary edema

  18. Postpartum Complications - Number of Participants With Cardiomyopathy

    Time frame: 10 days postpartum

    Cardiomyopathy

  19. Postpartum Complications- Number of Participants With Maternal Death

    Time frame: 10 days postpartum

    Maternal death

  20. Receipt of Additional Antihypertensive During Admission

    Time frame: 6 weeks postpartum

    Receipt of additional antihypertensive during admission at 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial

Acronym: ACE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 20, 2021
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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