Trial · NCT03506724
Response to Anti-hypertensives in Pregnant and Postpartum Patients
NCT03506724, Phase 4, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2021-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Response to Anti-hypertensives in Pregnant and Postpartum Patients. Trials, record NCT03506724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03506724
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Response to Anti-hypertensives in Pregnant and Postpartum Patients
- NCT number
- NCT03506724
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 109 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Hypertension in Pregnancy, Preeclampsia
- Interventions
- Nifedipine, Labetalol
- First posted
- 2018-04-24
- Last updated
- 2021-05-24
- Results first posted
- 2021-05-24
- Limitations and caveats
- Small sample size and the study was not double blind
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Achieve Non Severe Range Blood Pressure | Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour | Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received. |
| Primary | Number of Participants to Achieve Non Severe Range Blood Pressure | up to 1 hour | Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received. |
| Secondary | Frequency of Genetic Variants of Genes | up to 1 year | the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population. |
| Secondary | Number of Participants With Medication Side Effects | assessed 10 minutes to 1 hour after medication is given | Number of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Achieve Non Severe Range Blood Pressure | Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour | minutes | MEDIAN | |
| PRIMARY | Number of Participants to Achieve Non Severe Range Blood Pressure | up to 1 hour | participants by ethnicity | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Genetic Variants of Genes | up to 1 year | data not collected | ||
| SECONDARY | Number of Participants With Medication Side Effects | assessed 10 minutes to 1 hour after medication is given | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Achieve Non Severe Range Blood Pressure | Intravenous Labetalol | 10 | Inter-Quartile Range 10 to 20 | minutes | |
| Time to Achieve Non Severe Range Blood Pressure | Oral Nifedipine | 20 | Inter-Quartile Range 20 to 30 | minutes | |
| Number of Participants to Achieve Non Severe Range Blood Pressure | Intravenous Labetalol | White, Asian, and Hispanic | 33 | Participants | |
| Number of Participants to Achieve Non Severe Range Blood Pressure | Oral Nifedipine | White, Asian, and Hispanic | 31 | Participants | |
| Number of Participants to Achieve Non Severe Range Blood Pressure | Intravenous Labetalol | Black | 18 | Participants | |
| Number of Participants to Achieve Non Severe Range Blood Pressure | Oral Nifedipine | Black | 22 | Participants | |
| Number of Participants With Medication Side Effects | Intravenous Labetalol | Headache | 6 | Participants | |
| Number of Participants With Medication Side Effects | Oral Nifedipine | Headache | 10 | Participants | |
| Number of Participants With Medication Side Effects | Intravenous Labetalol | Nausea | 3 | Participants | |
| Number of Participants With Medication Side Effects | Oral Nifedipine | Nausea | 7 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Nifedipine | 54 | |
| Overall Study | STARTED | Intravenous Labetalol | 55 | |
| Overall Study | COMPLETED | Oral Nifedipine | 54 | |
| Overall Study | COMPLETED | Intravenous Labetalol | 55 | |
| Overall Study | NOT COMPLETED | Oral Nifedipine | 0 | |
| Overall Study | NOT COMPLETED | Intravenous Labetalol | 0 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| other | symptomatic hypotenstion | Pregnancy, puerperium and perinatal conditions | Intravenous Labetalol | 0 | 55 | |
| other | symptomatic hypotenstion | Pregnancy, puerperium and perinatal conditions | Oral Nifedipine | 1 | 54 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravenous Labetalol | 0 | 55 |
| Total, all-cause mortality | Oral Nifedipine | 0 | 54 |
| Total, other adverse events | Intravenous Labetalol | 0 | 55 |
| Total, other adverse events | Oral Nifedipine | 1 | 54 |
| Total, serious adverse events | Intravenous Labetalol | 0 | 55 |
| Total, serious adverse events | Oral Nifedipine | 0 | 54 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intravenous Labetalol vs Oral Nifedipine: deaths from any cause | Trial comparisons |
| Intravenous Labetalol vs Oral Nifedipine: serious adverse events | Trial comparisons |
Tests0
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/NCT03506724
GET https://conductscience.org/api/trials/v1/NCT03506724/registered