Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.
This study has been completed.
Sponsor:
Stanford University
Collaborator:
Santa Clara Valley Health & Hospital System
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185952
First received: September 12, 2005
Last updated: June 10, 2011
Last verified: June 2011
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | June 10, 2011 | ||||
| Start Date ICMJE | November 2001 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Achieving 37 weeks gestation [ Time Frame: delivery ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Achieving 37 weeks gestation | ||||
| Change History | Complete list of historical versions of study NCT00185952 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor. | ||||
| Official Title ICMJE | Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial | ||||
| Brief Summary | Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor |
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| Detailed Description | To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Nifedipine
Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours. |
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| Study Arm (s) |
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| Publications * | Lyell DJ, Pullen KM, Mannan J, Chitkara U, Druzin ML, Caughey AB, El-Sayed YY. Maintenance nifedipine tocolysis compared with placebo: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1221-6. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 70 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - arrested preterm labor Exclusion Criteria: - ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis |
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| Gender | Female | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00185952 | ||||
| Other Study ID Numbers ICMJE | 76251 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yasser Yehia El-Sayed, Stanford University School of Medicine | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Santa Clara Valley Health & Hospital System | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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