Vaginal Progesterone Versus Placebo in Multiple Pregnancy
This study has been completed.
Sponsor:
University of Calgary
Collaborators:
Calgary Health Region
Columbia Laboratories
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00343265
First received: June 20, 2006
Last updated: September 1, 2011
Last verified: August 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 20, 2006 | ||||||||
| Last Updated Date | September 1, 2011 | ||||||||
| Start Date ICMJE | June 2006 | ||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Gestational age [ Time Frame: Delivery ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Gestational age | ||||||||
| Change History | Complete list of historical versions of study NCT00343265 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 | Vaginal Progesterone Versus Placebo in Multiple Pregnancy | ||||||||
| Official Title ICMJE | Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy | ||||||||
| Brief Summary | The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies. |
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| Detailed Description | Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Preterm Birth | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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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 | 84 | ||||||||
| Completion Date | March 2011 | ||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00343265 | ||||||||
| Other Study ID Numbers ICMJE | 18589, 9427-U0206-47C, 104425 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Stephen Wood, University of Calgary | ||||||||
| Study Sponsor ICMJE | University of Calgary | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Calgary | ||||||||
| Verification Date | August 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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