Trial · NCT04392375
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
NCT04392375, Phase 4, Completed, Ohio State University; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor. Trials, record NCT04392375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04392375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
- NCT number
- NCT04392375
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 110 participants, actual
- Lead sponsor
- Ohio State University
- Conditions
- Preeclampsia Severe
- Interventions
- Nifedipine 30 MG, Placebos
- First posted
- 2020-05-18
- Last updated
- 2023-07-24
- Results first posted
- 2023-07-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Between enrollment and delivery, assessed up to 18 weeks | Measured acute antihypertension therapy between enrollment and delivery |
| Secondary | Number of Participants Stratified by Route of Delivery | At delivery | |
| Secondary | Number of Participants With Various Indications for Cesarean Delivery | Between enrollment and delivery, assessed up to 18 weeks | Some participants could have more than one indication for Cesarean Delivery. |
| Secondary | Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy | Between enrollment and delivery, assessed up to 18 weeks | |
| Secondary | Number of Participants Who Required Acute Antihypertension Treatments Postpartum | At delivery |
Source ClinicalTrials.gov
Outcomes5
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 the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Between enrollment and delivery, assessed up to 18 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Stratified by Route of Delivery | At delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Various Indications for Cesarean Delivery | Between enrollment and delivery, assessed up to 18 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy | Between enrollment and delivery, assessed up to 18 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Required Acute Antihypertension Treatments Postpartum | At delivery | 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 |
|---|---|---|---|---|---|
| Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Nifedipine 30MG | 18 | Participants | ||
| Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Placebo | 27 | Participants | ||
| Number of Participants Stratified by Route of Delivery | Nifedipine 30MG | Cesarean Delivery | 11 | Participants | |
| Number of Participants Stratified by Route of Delivery | Placebo | Cesarean Delivery | 17 | Participants | |
| Number of Participants Stratified by Route of Delivery | Nifedipine 30MG | Vaginal Delivery | 42 | Participants | |
| Number of Participants Stratified by Route of Delivery | Placebo | Vaginal Delivery | 32 | Participants | |
| Number of Participants With Various Indications for Cesarean Delivery | Nifedipine 30MG | First stage arrest | 8 | Participants | |
| Number of Participants With Various Indications for Cesarean Delivery | Placebo | First stage arrest | 6 | Participants | |
| Number of Participants With Various Indications for Cesarean Delivery | Nifedipine 30MG | Second stage arrest | 1 | Participants | |
| Number of Participants With Various Indications for Cesarean Delivery | Placebo | Second stage arrest | 5 | 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 | Nifedipine 30MG | 55 | |
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | COMPLETED | Nifedipine 30MG | 53 | |
| Overall Study | COMPLETED | Placebo | 49 | |
| Overall Study | NOT COMPLETED | Nifedipine 30MG | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nifedipine 30MG | 0 | 55 |
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, other adverse events | Nifedipine 30MG | 0 | 55 |
| Total, other adverse events | Placebo | 0 | 55 |
| Total, serious adverse events | Nifedipine 30MG | 0 | 55 |
| Total, serious adverse events | Placebo | 0 | 55 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36189646 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nifedipine 30MG vs Placebo: Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy | Trial comparisons |
| Nifedipine 30MG vs Placebo: Number of Participants Who Required Acute Antihypertension Treatments Postpartum | Trial comparisons |
| Nifedipine 30MG vs Placebo: deaths from any cause | Trial comparisons |
| Nifedipine 30MG vs Placebo: Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Trial comparisons |
| Nifedipine 30MG vs Placebo: 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/NCT04392375
GET https://conductscience.org/api/trials/v1/NCT04392375/registered