Phase 4
N=70
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
Hypertension in Pregnancy · Postpartum Preeclampsia
Bottom Line
View on ClinicalTrials.gov: NCT05049616 ↗Enrolled (actual)
70
Serious AEs
2.9%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants With Stage 2 Hypertension — 8; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ACE Inhibitors and Diuretics (Drug); NIFEdipine ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stage 2 Hypertension |
8; 12 | — |
| SECONDARY Number of Participants With Severe Postpartum Hypertension |
6; 5 | — |
| SECONDARY Number of Participants Who Received Additional Antihypertensive During Admission |
6; 5 | — |
| SECONDARY Postpartum Length of Stay |
4; 3 | — |
| SECONDARY Postpartum Readmission |
5; 1 | — |
| SECONDARY Time to Blood Pressure Control |
— | — |
| SECONDARY Incidence of Persistent Postpartum Hypertension |
— | — |
| SECONDARY Occurrence of Proteinuria |
— | — |
| SECONDARY Presense of Labs Abnormality |
— | — |
| SECONDARY Compliance With Medications |
22; 26 | — |
| SECONDARY Time to Control Blood Pressure |
— | — |
| SECONDARY Number of Patients Receiving Primary Care With BP Measurement |
— | — |
| SECONDARY Postpartum Complications- Number of Participants With ICU Admission |
2; 0 | — |
| SECONDARY Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome |
1; 0 | — |
| SECONDARY Postpartum Complications- Number of Participants With Eclampsia |
0; 0 | — |
| SECONDARY Postpartum Complications- Number of Participants With Stroke |
0; 0 | — |
| SECONDARY Postpartum Complications- Number of Participants With Renal Failure |
0; 0 | — |
| SECONDARY Postpartum Complications- Number of Participants With Pulmonary Edema |
1; 0 | — |
| SECONDARY Postpartum Complications - Number of Participants With Cardiomyopathy |
1; 0 | — |
| SECONDARY Postpartum Complications- Number of Participants With Maternal Death |
0; 0 | — |
| SECONDARY Receipt of Additional Antihypertensive During Admission |
— | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05049616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.