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Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
Phase 4 trial testing ACE Inhibitors and Diuretics in Hypertension in Pregnancy in 70 participants. Completed in 1 September 2023.
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 18 October 2021 |
| Primary completion | 26 June 2022 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across United States |
The University of Texas Health Science Center, Houston
18 and older, female only, with Hypertension in Pregnancy or Postpartum Preeclampsia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 8 | |
| Extended release nifedipine | 12 |
severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart)
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 6 | |
| Extended release nifedipine | 5 |
number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 6 | |
| Extended release nifedipine | 5 |
time spent in hospital following delivery
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 4 | 3 – 5 |
| Extended release nifedipine | 3 | 3 – 4 |
occurrence of returning to hospital for admission postpartum
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 5 | |
| Extended release nifedipine | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 22 | |
| Extended release nifedipine | 26 |
Need for ICU admission
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 2 | |
| Extended release nifedipine | 0 |
Hemolysis, elevated liver enzymes, low platelet count: HELLP
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 1 | |
| Extended release nifedipine | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 0 | |
| Extended release nifedipine | 0 |
Stroke
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 0 | |
| Extended release nifedipine | 0 |
Renal failure
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 0 | |
| Extended release nifedipine | 0 |
Pulmonary edema
| Group | Value | 95% CI |
|---|---|---|
| Hctz/Lisinopril | 1 | |
| Extended release nifedipine | 0 |
Time frame: Up to 6 weeks post delivery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Hctz/Lisinopril | Extended release nifedipine |
|---|---|---|---|
| Intensive care unit admission | General disorders | — | — |
| HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome | Pregnancy, puerperium and perinatal conditions | — | — |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardiomyopathy | Cardiac disorders | — | — |
Most-reported serious reactions: Intensive care unit admission, HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome, Pulmonary edema, Cardiomyopathy.
Data from ClinicalTrials.gov NCT05049616 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05049616.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing