Trial · NCT05049616
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
NCT05049616, Phase 4, Completed, The University of Texas Health Science Center, Houston; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension. Trials, record NCT05049616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05049616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
- NCT number
- NCT05049616
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 70 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Hypertension in Pregnancy, Postpartum Preeclampsia
- Interventions
- ACE Inhibitors and Diuretics, NIFEdipine ER
- First posted
- 2021-09-20
- Last updated
- 2025-11-10
- Results first posted
- 2023-08-14
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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) |
| Secondary | 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. |
| Secondary | Postpartum Length of Stay | up to 30 days after delivery | time spent in hospital following delivery |
| Secondary | Postpartum Readmission | up to 30 days after delivery | occurrence of returning to hospital for admission postpartum |
| Secondary | 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). |
| Secondary | Incidence of Persistent Postpartum Hypertension | 6 weeks postpartum | Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg). |
| Secondary | Occurrence of Proteinuria | 7-10 days, and 6 weeks postpartum | Proteinuria is measured by urine protein creatinine ratio |
| Secondary | Presense of Labs Abnormality | 7-10 days, and 6 weeks postpartum | Labs abnormality including hyperkalemia or creatinine increase |
| Secondary | 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Stage 2 Hypertension | 7-10 after delivery | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Severe Postpartum Hypertension | 7-10 after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Received Additional Antihypertensive During Admission | 7-10 days postpartum | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Postpartum Length of Stay | up to 30 days after delivery | days | MEDIAN | |
| SECONDARY | Postpartum Readmission | up to 30 days after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Blood Pressure Control | 10 days | Data were not collected for this outcome measure. | ||
| SECONDARY | Incidence of Persistent Postpartum Hypertension | 6 weeks postpartum | Data were not collected for this outcome measure. | ||
| SECONDARY | Occurrence of Proteinuria | 7-10 days, and 6 weeks postpartum | Data were not collected for this outcome measure | ||
| SECONDARY | Presense of Labs Abnormality | 7-10 days, and 6 weeks postpartum | Data were not collected for this outcome measure | ||
| SECONDARY | Compliance With Medications | at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth | 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 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Stage 2 Hypertension | Hctz/Lisinopril | 8 | Participants | ||
| Number of Participants With Stage 2 Hypertension | Extended release nifedipine | 12 | Participants | ||
| Number of Participants With Severe Postpartum Hypertension | Hctz/Lisinopril | 6 | Participants | ||
| Number of Participants With Severe Postpartum Hypertension | Extended release nifedipine | 5 | Participants | ||
| Number of Participants Who Received Additional Antihypertensive During Admission | Hctz/Lisinopril | 6 | Participants | ||
| Number of Participants Who Received Additional Antihypertensive During Admission | Extended release nifedipine | 5 | Participants | ||
| Postpartum Length of Stay | Hctz/Lisinopril | 4 | Inter-Quartile Range 3 to 5 | days | |
| Postpartum Length of Stay | Extended release nifedipine | 3 | Inter-Quartile Range 3 to 4 | days | |
| Postpartum Readmission | Hctz/Lisinopril | 5 | Participants | ||
| Postpartum Readmission | Extended release nifedipine | 1 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hctz/Lisinopril | 34 | |
| Overall Study | STARTED | Extended release nifedipine | 36 | |
| Overall Study | COMPLETED | Hctz/Lisinopril | 31 | |
| Overall Study | COMPLETED | Extended release nifedipine | 36 | |
| Overall Study | NOT COMPLETED | Hctz/Lisinopril | 3 | |
| Overall Study | NOT COMPLETED | Extended release nifedipine | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Intensive care unit admission | General disorders | Hctz/Lisinopril | 2 | 34 | |
| serious | Intensive care unit admission | General disorders | Extended release nifedipine | 0 | 36 | |
| serious | HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome | Pregnancy, puerperium and perinatal conditions | Hctz/Lisinopril | 1 | 34 | |
| serious | HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome | Pregnancy, puerperium and perinatal conditions | Extended release nifedipine | 0 | 36 | |
| serious | Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Hctz/Lisinopril | 1 | 34 | |
| serious | Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Extended release nifedipine | 0 | 36 | |
| serious | Cardiomyopathy | Cardiac disorders | Hctz/Lisinopril | 1 | 34 | |
| serious | Cardiomyopathy | Cardiac disorders | Extended release nifedipine | 0 | 36 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hctz/Lisinopril | 0 | 34 |
| Total, all-cause mortality | Extended release nifedipine | 0 | 36 |
| Total, other adverse events | Hctz/Lisinopril | 0 | 34 |
| Total, other adverse events | Extended release nifedipine | 0 | 36 |
| Total, serious adverse events | Hctz/Lisinopril | 2 | 34 |
| Total, serious adverse events | Extended release nifedipine | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons15
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hctz/Lisinopril vs Extended release nifedipine: Compliance With Medications | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Postpartum Complications - Number of Participants With Cardiomyopathy | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Postpartum Complications- Number of Participants With Renal Failure | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Postpartum Complications- Number of Participants With Stroke | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Number of Participants With Severe Postpartum Hypertension | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Postpartum Complications- Number of Participants With Pulmonary Edema | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Number of Participants With Stage 2 Hypertension | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Postpartum Complications- Number of Participants With Eclampsia | Trial comparisons |
| Hctz/Lisinopril vs Extended release nifedipine: Number of Participants Who Received Additional Antihypertensive During Admission | Trial comparisons |
1 to 10 of 15
See all 15 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05049616
GET https://conductscience.org/api/trials/v1/NCT05049616/registered?page=2