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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 28, 2008 | ||||||||
| Last Updated Date | October 3, 2008 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary outcome of this study is the rate of expulsion of an IUD placed after medical abortion. [ Time Frame: Three months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00621543 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
The secondary outcome will be rate of continuation of IUD use, when placed after medical abortion. [ Time Frame: Three months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Insertion of an IUD After Medical Abortion | ||||||||
| Official Title ICMJE | Insertion of an IUD After Medical Abortion | ||||||||
| Brief Summary | The purpose of this study is to determine the expulsion and continuation rate of an IUD placed immediately after medical abortion. Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy). |
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| Detailed Description | Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an IUD at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label, Uncontrolled, Single Group Assignment | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Copper T-380A or Levonorgestrel IUS | ||||||||
| Study Arms / Comparison Groups | Experimental: Women choosing intra-uterine contraception after medical abortion. | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 120 | ||||||||
| Completion Date | September 2008 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 64 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 ID ICMJE | NCT00621543 | ||||||||
| Responsible Party | Dr. Sarah J. Betstadt, Boston University | ||||||||
| Study ID Numbers ICMJE | H-24902, H-24902 | ||||||||
| Study Sponsor ICMJE | Boston University | ||||||||
| Collaborators ICMJE | University of Utah | ||||||||
| Investigators ICMJE |
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| Information Provided By | Boston University | ||||||||
| Verification Date | October 2008 | ||||||||
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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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