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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryTime to Achieve Non Severe Range Blood PressureTen minute intervals from the time of the first severe range blood pressure, up to 1 hourTime to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
PrimaryNumber of Participants to Achieve Non Severe Range Blood Pressureup to 1 hourNumber of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
SecondaryFrequency of Genetic Variants of Genesup to 1 yearthe frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population.
SecondaryNumber of Participants With Medication Side Effectsassessed 10 minutes to 1 hour after medication is givenNumber of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTime to Achieve Non Severe Range Blood PressureTen minute intervals from the time of the first severe range blood pressure, up to 1 hourminutesMEDIAN
PRIMARYNumber of Participants to Achieve Non Severe Range Blood Pressureup to 1 hourparticipants by ethnicityParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYFrequency of Genetic Variants of Genesup to 1 yeardata not collected
SECONDARYNumber of Participants With Medication Side Effectsassessed 10 minutes to 1 hour after medication is givenParticipantsCOUNT_OF_PARTICIPANTS

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Time to Achieve Non Severe Range Blood PressureIntravenous Labetalol10Inter-Quartile Range 10 to 20minutes
Time to Achieve Non Severe Range Blood PressureOral Nifedipine20Inter-Quartile Range 20 to 30minutes
Number of Participants to Achieve Non Severe Range Blood PressureIntravenous LabetalolWhite, Asian, and Hispanic33Participants
Number of Participants to Achieve Non Severe Range Blood PressureOral NifedipineWhite, Asian, and Hispanic31Participants
Number of Participants to Achieve Non Severe Range Blood PressureIntravenous LabetalolBlack18Participants
Number of Participants to Achieve Non Severe Range Blood PressureOral NifedipineBlack22Participants
Number of Participants With Medication Side EffectsIntravenous LabetalolHeadache6Participants
Number of Participants With Medication Side EffectsOral NifedipineHeadache10Participants
Number of Participants With Medication Side EffectsIntravenous LabetalolNausea3Participants
Number of Participants With Medication Side EffectsOral NifedipineNausea7Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDOral Nifedipine54
Overall StudySTARTEDIntravenous Labetalol55
Overall StudyCOMPLETEDOral Nifedipine54
Overall StudyCOMPLETEDIntravenous Labetalol55
Overall StudyNOT COMPLETEDOral Nifedipine0
Overall StudyNOT COMPLETEDIntravenous Labetalol0

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
othersymptomatic hypotenstionPregnancy, puerperium and perinatal conditionsIntravenous Labetalol055
othersymptomatic hypotenstionPregnancy, puerperium and perinatal conditionsOral Nifedipine154

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIntravenous Labetalol055
Total, all-cause mortalityOral Nifedipine054
Total, other adverse eventsIntravenous Labetalol055
Total, other adverse eventsOral Nifedipine154
Total, serious adverse eventsIntravenous Labetalol055
Total, serious adverse eventsOral Nifedipine054

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.

ComparisonSource
Intravenous Labetalol vs Oral Nifedipine: deaths from any causeTrial comparisons
Intravenous Labetalol vs Oral Nifedipine: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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