Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

The University of Texas Health Science Center, Houston70 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 7-10 after delivery

Secondary Outcomes

Number of Participants With Severe Postpartum Hypertension

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

Time frame: 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.

Time frame: 7-10 days postpartum

Postpartum Length of Stay

time spent in hospital following delivery

Time frame: up to 30 days after delivery

Postpartum Readmission

occurrence of returning to hospital for admission postpartum

Time frame: 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).

Time frame: 10 days

Incidence of Persistent Postpartum Hypertension

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

Time frame: 6 weeks postpartum

Occurrence of Proteinuria

Proteinuria is measured by urine protein creatinine ratio

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

Presense of Labs Abnormality

Labs abnormality including hyperkalemia or creatinine increase

Time frame: 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.

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

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

Time frame: 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

Time frame: 1 year postpartum

Postpartum Complications- Number of Participants With ICU Admission

Need for ICU admission