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The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine | Experimental | Women with preterm labor will receive nifedipine. |
|
| Placebo | Experimental | Women with preterm labor will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine | Drug | Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Preterm Birth | Less than 37 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Preterm Birth | Within 48 hours of randomization | |
| Number of Participants With Preterm Birth | At least 2 doses of betamethasone administered prior to delivery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Casey, MD | Department of Alabama Medical Center, Birmingham, AL | Study Director |
| Donald D McIntire, PhD | University of Texas Southwestern Medical Center | Study Director |
| Kenneth J Leveno, MD | University of Texas Southwestern Medical Center | Study Director |
| Chet E Wells, MD | University of Texas Southwestern Medical Center | Study Director |
| Josiah S Hawkins, MD | Kaiser Medical Center, Oakland, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Memorial Hospital | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35947046 | Derived | Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2. | |
| 34259466 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nifedipine | Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor. |
| FG001 | Placebo | Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nifedipine | Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Preterm Birth | Posted | Count of Participants | Participants | Less than 37 weeks of gestation |
|
4 years
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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 | Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chet Edward Wells, MD | UT Southwestern Medical Center | 214-648-2316 | dawn.wilson@utsouthwestern.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 22, 2018 | Feb 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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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| Placebo | Drug | Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. |
|
| Usual care | Other | Usual evaluation, monitoring and care for women with preterm labor. |
|
| Number of Participants With Preterm Birth |
| Within 7 days of randomization |
| Hawkins JS, Wells CE, Casey BM, McIntire DD, Leveno KJ. Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial. Obstet Gynecol. 2021 Jul 1;138(1):73-78. doi: 10.1097/AOG.0000000000004436. |
| Placebo |
Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Number of Participants With Preterm Birth | Posted | Count of Participants | Participants | Within 48 hours of randomization |
|
|
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| Secondary | Number of Participants With Preterm Birth | Posted | Count of Participants | Participants | At least 2 doses of betamethasone administered prior to delivery |
|
|
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| Secondary | Number of Participants With Preterm Birth | Posted | Count of Participants | Participants | Within 7 days of randomization |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Placebo | Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor. | 0 | 42 | 0 | 42 | 0 | 42 |
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