Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

Phase 4

Active, not recruiting

• Conditions: Postpartum Preeclampsia; Hypertension in Pregnancy
• Interventions: Drug: ACE Inhibitors and Diuretics; Drug: NIFEdipine ER

• Registration Number: NCT05049616
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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 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 Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-20
• Study Start: 2021-10-18
• Primary Completion: 2022-06-26
• Results First Submitted: 2023-06-26
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Results First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hctz/Lisinopril	ACE Inhibitors and Diuretics	Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)
Extended release nifedipine	NIFEdipine ER	calcium channel blocker (Nifedipine

Primary Outcome Measures

Name	Time	Method
Number of Participants With Stage 2 Hypertension	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 Outcome Measures

Name	Time	Method
Postpartum Length of Stay	up to 30 days after delivery	time spent in hospital following delivery
Postpartum Readmission	up to 30 days after delivery	occurrence of returning to hospital for admission postpartum
Number of Participants With Severe Postpartum Hypertension	7-10 after delivery	severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart)
Time to Blood Pressure Control	10 days	The time from delivery to Blood Pressure control (i.e time from delivery to last BP \<150/100).
Incidence of Persistent Postpartum Hypertension	6 weeks postpartum	Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg).
Occurrence of Proteinuria	7-10 days, and 6 weeks postpartum	Proteinuria is measured by urine protein creatinine ratio
Presense of Labs Abnormality	7-10 days, and 6 weeks postpartum	Labs abnormality including hyperkalemia or creatinine increase
Compliance With Medications	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.
Number of Participants Who Received Additional Antihypertensive During Admission	7-10 days postpartum	number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.
Time to Control Blood Pressure	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
Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome	10 days postpartum	Hemolysis, elevated liver enzymes, low platelet count: HELLP
Postpartum Complications- Number of Participants With Renal Failure	10 days postpartum	Renal failure
Postpartum Complications- Number of Participants With Pulmonary Edema	10 days postpartum	Pulmonary edema
Percentage of Patients Receiving Primary Care With BP Measurement	1 year postpartum	Percentage of patients receiving primary care with BP measurement at 1 year
Postpartum Complications- Number of Participants With ICU Admission	10 days postpartum	Need for ICU admission
Postpartum Complications- Number of Participants With Stroke	10 days postpartum	Stroke
Postpartum Complications- Number of Participants With Eclampsia	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.
Postpartum Complications - Number of Participants With Cardiomyopathy	10 days postpartum	Cardiomyopathy
Postpartum Complications- Number of Participants With Maternal Death	10 days postpartum	Maternal death
Receipt of Additional Antihypertensive During Admission	6 weeks postpartum	Receipt of additional antihypertensive during admission at 6 weeks postpartum

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States