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This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.
After diagnosis of preeclampsia with severe features and decision made to proceed with induction of labor. Patients were approached about study and if consented then were then randomized to placebo or nifedipine 30XL daily until delivery occurred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine 30MG | Active Comparator | Oral administration of 30mg Nifedipine XL q24 hours until delivery |
|
| Placebo | Placebo Comparator | Matching placebo group q24hrs until delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine 30 MG | Drug | Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Measured acute antihypertension therapy between enrollment and delivery | Between enrollment and delivery, assessed up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Stratified by Route of Delivery | At delivery | |
| Number of Participants With Various Indications for Cesarean Delivery | Some participants could have more than one indication for Cesarean Delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36189646 | Derived | Cleary EM, Racchi NW, Patton KG, Kudrimoti M, Costantine MM, Rood KM. Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension Among Pregnant Individuals With Preeclampsia With Severe Features. Hypertension. 2023 Feb;80(2):335-342. doi: 10.1161/HYPERTENSIONAHA.122.19751. Epub 2022 Oct 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nifedipine 30MG | Oral administration of 30mg Nifedipine XL q24 hours until delivery Nifedipine 30 MG: Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure. |
| FG001 | Placebo | Matching placebo group q24hrs until delivery Placebos: At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nifedipine 30MG | Oral administration of 30mg Nifedipine XL q24 hours until delivery Nifedipine 30 MG: Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Measured acute antihypertension therapy between enrollment and delivery | Posted | Count of Participants | Participants | Between enrollment and delivery, assessed up to 18 weeks |
|
Between enrollment and delivery, assessed up to 18 weeks
An adverse event (AE) will be defined as any untoward or unfavorable medical occurrence in a study participant, whether or not considered related to the subject's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nifedipine 30MG | Oral administration of 30mg Nifedipine XL q24 hours until delivery Nifedipine 30 MG: Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Rood, MD | The Ohio State University | 440-321-0264 | Kara.Rood@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2020 | May 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
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|
| Placebos | Drug | At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo. |
|
| Between enrollment and delivery, assessed up to 18 weeks |
| 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 |
| Number of Participants Who Required Acute Antihypertension Treatments Postpartum | At delivery |
| BG001 | Placebo | Matching placebo group q24hrs until delivery Placebos: At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pregnancy BMI | Median | Inter-Quartile Range | kg/m 2 |
|
| BMI at delivery | Median | Inter-Quartile Range | kg/m 2 |
|
| Nulliparous | Count of Participants | Participants |
|
| Chronic Hypertension | Count of Participants | Participants |
|
| Chronic hypertension on maintenance medication (beta-blocker) | Count of Participants | Participants |
|
| Smoking during current pregnancy | Count of Participants | Participants |
|
| Diabates | Count of Participants | Participants |
|
| Gestational age at delivery (week) | Count of Participants | Participants |
|
| Neuraxial anesthesia | Count of Participants | Participants |
|
| Twin gestation | Count of Participants | Participants |
|
| Fetal Growth Restriction | Count of Participants | Participants |
|
Matching placebo group q24hrs until delivery Placebos: At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo. |
|
|
| Secondary | Number of Participants Stratified by Route of Delivery | Posted | Count of Participants | Participants | At delivery |
|
|
|
| Secondary | Number of Participants With Various Indications for Cesarean Delivery | Some participants could have more than one indication for Cesarean Delivery. | Posted | Count of Participants | Participants | Between enrollment and delivery, assessed up to 18 weeks |
|
|
|
| Secondary | Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy | Posted | Count of Participants | Participants | Between enrollment and delivery, assessed up to 18 weeks |
|
|
|
| Secondary | Number of Participants Who Required Acute Antihypertension Treatments Postpartum | Posted | Count of Participants | Participants | At delivery |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Placebo | Matching placebo group q24hrs until delivery Placebos: At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo. | 0 | 55 | 0 | 55 | 0 | 55 |
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| Nonreassuring fetal status |
|
| Worsening maternal status |
|