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Sponsors and Collaborators: |
Boston University University of Utah |
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Information provided by: | Boston University |
ClinicalTrials.gov Identifier: | NCT00621543 |
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).
Condition | Intervention |
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Intrauterine Device Expulsion Medical Abortion Induced Abortion |
Device: Copper T-380A or Levonorgestrel IUS |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Insertion of an IUD After Medical Abortion |
Enrollment: | 120 |
Study Start Date: | March 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Observation- All subjects: Experimental
Women choosing intra-uterine contraception after medical abortion.
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Device: Copper T-380A or Levonorgestrel IUS
When a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the FDA instructions.
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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.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | Sarah J Betstadt, MD | Boston University |
Study Director: | Lynn Borgatta, MD, MPH | Boston University |
Responsible Party: | Boston University ( Dr. Sarah J. Betstadt ) |
Study ID Numbers: | H-24902, H-24902 |
Study First Received: | January 28, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00621543 History of Changes |
Health Authority: | United States: Institutional Review Board |
Intrauterine Device Induced Abortion Medical Abortion |
Contraceptive Agents Levonorgestrel Contraceptives, Oral Contraceptive Agents, Female Copper |
Contraceptive Agents Therapeutic Uses Levonorgestrel Contraceptives, Oral Physiological Effects of Drugs |
Contraceptive Agents, Female Contraceptives, Oral, Synthetic Reproductive Control Agents Pharmacologic Actions |