Hypertension in PregnancyPhase 4ACENCT05049616
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
A Phase 4 study testing ACE Inhibitors and Diuretics and NIFEdipine ER in people with Hypertension in Pregnancy and Postpartum Preeclampsia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy, Postpartum Preeclampsia
- What is being tested?
- ACE Inhibitors and Diuretics and NIFEdipine ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 1 Sep 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Hypertension in Pregnancy, Postpartum Preeclampsia
- Being tested
- ACE Inhibitors and Diuretics, NIFEdipine ER
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE Inhibitors and DiureticsDrug
Hctz/Lisinopril (brand name: Zestoretic)
NIFEdipine ERDrug
Extended release nifedipine
| Study group | Role | What they receive |
|---|---|---|
| Hctz/Lisinopril | Experimental | Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) Receives: Drug: ACE Inhibitors and Diuretics |
| Extended release nifedipine | Active comparator | calcium channel blocker (Nifedipine Receives: Drug: NIFEdipine ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stage 2 Hypertension
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.
Measured: 7-10 after delivery
Secondary outcomes (20)
Number of Participants With Severe Postpartum Hypertension
severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart)
Measured: 7-10 after delivery
Number of Participants Who Received Additional Antihypertensive During Admission
number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.
Measured: 7-10 days postpartum
Postpartum Length of Stay
time spent in hospital following delivery
Measured: up to 30 days after delivery
Postpartum Readmission
occurrence of returning to hospital for admission postpartum
Measured: up to 30 days after delivery
Time to Blood Pressure Control
The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100).
Measured: 10 days
Incidence of Persistent Postpartum Hypertension
Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg).
Measured: 6 weeks postpartum
Occurrence of Proteinuria
Proteinuria is measured by urine protein creatinine ratio
Measured: 7-10 days, and 6 weeks postpartum
Presense of Labs Abnormality
Labs abnormality including hyperkalemia or creatinine increase
Measured: 7-10 days, and 6 weeks postpartum
Compliance With Medications
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.
Measured: at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth
Time to Control Blood Pressure
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
Measured: 3 month-1 year
Number of Patients Receiving Primary Care With BP Measurement
Number of patients receiving primary care with BP measurement at 1 year
Measured: 1 year postpartum
Postpartum Complications- Number of Participants With ICU Admission
Need for ICU admission
Measured: 10 days postpartum
Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome
Hemolysis, elevated liver enzymes, low platelet count: HELLP
Measured: 10 days postpartum
Postpartum Complications- Number of Participants With Eclampsia
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.
Measured: 10 days postpartum
Postpartum Complications- Number of Participants With Stroke
Stroke
Measured: 10 days postpartum
Postpartum Complications- Number of Participants With Renal Failure
Renal failure
Measured: 10 days postpartum
Postpartum Complications- Number of Participants With Pulmonary Edema
Pulmonary edema
Measured: 10 days postpartum
Postpartum Complications - Number of Participants With Cardiomyopathy
Cardiomyopathy
Measured: 10 days postpartum
Postpartum Complications- Number of Participants With Maternal Death
Maternal death
Measured: 10 days postpartum
Receipt of Additional Antihypertensive During Admission
Receipt of additional antihypertensive during admission at 6 weeks postpartum
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start18 Oct 2021
- Primary completion26 Jun 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Fishel Bartal, The University of Texas Health Science Center, Houston
- Investigators
- Michal Fishel Bartal, MD, Principal investigator, UT Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049616
- Sponsor's protocol ID
- HSC-MS-21-0476
- Acronym
- ACE
- Status last verified
- Oct 2025
- First submitted
- 31 Aug 2021
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05049616
- Acronym / sponsor ID
- ACE / HSC-MS-21-0476
- Conditions
- Hypertension in Pregnancy, Postpartum Preeclampsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 26 Jun 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Hctz/Lisinopril | Experimental | Drug: ACE Inhibitors and DiureticsHctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) |
| Extended release nifedipine | Active comparator | Drug: NIFEdipine ERcalcium channel blocker (Nifedipine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE Inhibitors and DiureticsHctz/Lisinopril (brand name: Zestoretic) | Drug | Hctz/Lisinopril |
| NIFEdipine ERExtended release nifedipine | Drug | Extended release nifedipine |
Primary outcome
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.
20 secondary outcomes
Number of Participants With Severe Postpartum Hypertension
Time frame: 7-10 after delivery
Number of Participants Who Received Additional Antihypertensive During Admission
Time frame: 7-10 days postpartum
Postpartum Length of Stay
Time frame: up to 30 days after delivery
Postpartum Readmission
Time frame: up to 30 days after delivery
Time to Blood Pressure Control
Time frame: 10 days
Incidence of Persistent Postpartum Hypertension
Time frame: 6 weeks postpartum
Occurrence of Proteinuria
Time frame: 7-10 days, and 6 weeks postpartum
Presense of Labs Abnormality
Time frame: 7-10 days, and 6 weeks postpartum
Compliance With Medications
Time frame: at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth
Time to Control Blood Pressure
Time frame: 3 month-1 year
Number of Patients Receiving Primary Care With BP Measurement
Time frame: 1 year postpartum
Postpartum Complications- Number of Participants With ICU Admission
Time frame: 10 days postpartum
Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome
Time frame: 10 days postpartum
Postpartum Complications- Number of Participants With Eclampsia
Time frame: 10 days postpartum
Postpartum Complications- Number of Participants With Stroke
Time frame: 10 days postpartum
Postpartum Complications- Number of Participants With Renal Failure
Time frame: 10 days postpartum
Postpartum Complications- Number of Participants With Pulmonary Edema
Time frame: 10 days postpartum
Postpartum Complications - Number of Participants With Cardiomyopathy
Time frame: 10 days postpartum
Postpartum Complications- Number of Participants With Maternal Death
Time frame: 10 days postpartum
Receipt of Additional Antihypertensive During Admission
Time frame: 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Fishel Bartal, MD principal investigator
UT Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACE Inhibitors and Diuretics and NIFEdipine ER in people with Hypertension in Pregnancy and Postpartum Preeclampsia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Stage 2 Hypertension (time frame: 7-10 after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.