Trial Outcomes & Findings for Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension (NCT NCT05049616)

Last Updated: 2025-11-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

7-10 after delivery

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Hctz/Lisinopril Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Overall Study STARTED	34	36
Overall Study COMPLETED	31	36
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine	Total n=67 Participants Total of all reporting groups
Age, Customized <35 years	24 Participants n=5 Participants	20 Participants n=20 Participants	44 Participants n=40 Participants
Age, Customized >=35 years	7 Participants n=5 Participants	16 Participants n=20 Participants	23 Participants n=40 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	36 Participants n=20 Participants	67 Participants n=40 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race/Ethnicity, Customized Non-Hispanic White	3 Participants n=5 Participants	4 Participants n=20 Participants	7 Participants n=40 Participants
Race/Ethnicity, Customized Non-Hispanic Black	16 Participants n=5 Participants	24 Participants n=20 Participants	40 Participants n=40 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants	7 Participants n=20 Participants	16 Participants n=40 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	1 Participants n=20 Participants	4 Participants n=40 Participants
Region of Enrollment United States	31 participants n=5 Participants	36 participants n=20 Participants	67 participants n=40 Participants
Number of participants with private insurance for prenatal care	7 Participants n=5 Participants	18 Participants n=20 Participants	25 Participants n=40 Participants
Number of participants that are Married/living with partner	11 Participants n=5 Participants	14 Participants n=20 Participants	25 Participants n=40 Participants
Number of participants with Nulliparous	4 Participants n=5 Participants	7 Participants n=20 Participants	11 Participants n=40 Participants
Pre-pregnancy Body Mass Index	40.1 kg/m^2 n=5 Participants	37.8 kg/m^2 n=20 Participants	38.5 kg/m^2 n=40 Participants
Number of participants with a BMI ≥ 30	20 Participants n=5 Participants	25 Participants n=20 Participants	45 Participants n=40 Participants
Number of participants with Diabetes diagnosed prior to pregnancy	6 Participants n=5 Participants	7 Participants n=20 Participants	13 Participants n=40 Participants
Number of participants with Gestational diabetes	2 Participants n=5 Participants	5 Participants n=20 Participants	7 Participants n=40 Participants
Number of participants with Thyroid disease	1 Participants n=5 Participants	3 Participants n=20 Participants	4 Participants n=40 Participants
Number of participants who Smoke during pregnancy	1 Participants n=5 Participants	4 Participants n=20 Participants	5 Participants n=40 Participants
Number of participants with Alcohol use during pregnancy	0 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Number of participants with Substance use during pregnancy	1 Participants n=5 Participants	5 Participants n=20 Participants	6 Participants n=40 Participants
Number of participants with Chronic hypertension	14 Participants n=5 Participants	15 Participants n=20 Participants	29 Participants n=40 Participants
Number of participants who Use Blood Pressure medication during pregnancy	15 Participants n=5 Participants	13 Participants n=20 Participants	28 Participants n=40 Participants
Number of participants with Hypertensive disorder during pregnancy	28 Participants n=5 Participants	31 Participants n=20 Participants	59 Participants n=40 Participants
Number of participants with Preeclampsia with severe features	24 Participants n=5 Participants	27 Participants n=20 Participants	51 Participants n=40 Participants
Number of participants with New onset postpartum hypertension	0 Participants n=5 Participants	5 Participants n=20 Participants	5 Participants n=40 Participants
Number of participants who had labor induced	9 Participants n=5 Participants	18 Participants n=20 Participants	27 Participants n=40 Participants
Gestational weeks at delivery	34.4 weeks n=5 Participants	36.6 weeks n=20 Participants	35.4 weeks n=40 Participants
Number of pre-term delivery	25 Participants n=5 Participants	20 Participants n=20 Participants	45 Participants n=40 Participants
Number of Cesarean delivery	23 Participants n=5 Participants	20 Participants n=20 Participants	43 Participants n=40 Participants
Number of participants who Need IV Blood Pressure medications prior to randomization	11 Participants n=5 Participants	11 Participants n=20 Participants	22 Participants n=40 Participants
Postpartum day at randomization	1.4 days n=5 Participants	1.0 days n=20 Participants	1.2 days n=40 Participants

PRIMARY outcome

Timeframe: 7-10 after delivery

Population: Data were not collected for 1 participants in the Hctz/Lisionpril arm. Data were not collected for 8 participants in the extended release nifedipine arm.

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=30 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=28 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Number of Participants With Stage 2 Hypertension	8 Participants	12 Participants

SECONDARY outcome

Timeframe: 7-10 after delivery

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

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Number of Participants With Severe Postpartum Hypertension	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 7-10 days postpartum

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

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Number of Participants Who Received Additional Antihypertensive During Admission	6 Participants	5 Participants

SECONDARY outcome

Timeframe: up to 30 days after delivery

time spent in hospital following delivery

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Length of Stay	4 days Interval 3.0 to 5.0	3 days Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: up to 30 days after delivery

occurrence of returning to hospital for admission postpartum

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Readmission	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 10 days

Population: Data were not collected for this outcome measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks postpartum

Population: Data were not collected for this outcome measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7-10 days, and 6 weeks postpartum

Population: Data were not collected for this outcome measure

Proteinuria is measured by urine protein creatinine ratio

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7-10 days, and 6 weeks postpartum

Population: Data were not collected for this outcome measure

Labs abnormality including hyperkalemia or creatinine increase

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data were not collected for 4 participants in the Hctz/Lisinopril arm. Data were not collected for 8 participants in the Extended release nifedipine arm

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.

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=27 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=28 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Compliance With Medications	22 Participants	26 Participants

SECONDARY outcome

Timeframe: 3 month-1 year

Population: Data were not collected for this outcome measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year postpartum

Population: Data were not collected for this outcome because participants were lost to follow up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 days postpartum

Need for ICU admission

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications- Number of Participants With ICU Admission	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days postpartum

Hemolysis, elevated liver enzymes, low platelet count: HELLP

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications- Number of Participants With Eclampsia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days postpartum

Stroke

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications- Number of Participants With Stroke	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days postpartum

Renal failure

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications- Number of Participants With Renal Failure	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days postpartum

Pulmonary edema

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications- Number of Participants With Pulmonary Edema	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days postpartum

Cardiomyopathy

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications - Number of Participants With Cardiomyopathy	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days postpartum

Maternal death

Outcome measures

Outcome measures
Measure	Hctz/Lisinopril n=31 Participants Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 Participants calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
Postpartum Complications- Number of Participants With Maternal Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks postpartum

Population: Data were not collected for this outcome measure

Receipt of additional antihypertensive during admission at 6 weeks postpartum

Outcome measures

Outcome data not reported

Adverse Events

Hctz/Lisinopril

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Extended release nifedipine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hctz/Lisinopril n=34 participants at risk Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic)	Extended release nifedipine n=36 participants at risk calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine
General disorders Intensive care unit admission	5.9% 2/34 • Up to 6 weeks post delivery	0.00% 0/36 • Up to 6 weeks post delivery
Pregnancy, puerperium and perinatal conditions HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome	2.9% 1/34 • Up to 6 weeks post delivery	0.00% 0/36 • Up to 6 weeks post delivery
Respiratory, thoracic and mediastinal disorders Pulmonary edema	2.9% 1/34 • Up to 6 weeks post delivery	0.00% 0/36 • Up to 6 weeks post delivery
Cardiac disorders Cardiomyopathy	2.9% 1/34 • Up to 6 weeks post delivery	0.00% 0/36 • Up to 6 weeks post delivery

Other adverse events

Adverse event data not reported

Additional Information

Michal Fishel Bartal, MD

The University of Texas Health Science Center at Houston

Phone: (713) 500-6421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place