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Insertion of an IUD After Medical Abortion
This study has been completed.
Study NCT00621543   Information provided by Boston University
First Received: January 28, 2008   Last Updated: October 3, 2008   History of Changes

January 28, 2008
October 3, 2008
March 2006
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00621543 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Insertion of an IUD After Medical Abortion
Insertion of an IUD After Medical Abortion

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).

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.

 
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment
  • Intrauterine Device Expulsion
  • Medical Abortion
  • Induced Abortion
Device: Copper T-380A or Levonorgestrel IUS
Experimental: Women choosing intra-uterine contraception after medical abortion.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
September 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who completed a medical abortion in the last 14 days
  • At least 18 years old.
  • Desiring long-term contraception with an IUD.
  • Able and willing to give consent for participation in research.
  • Gonorrhea and chlamydia screen negative within 60 days of entry to study.
  • Willing to comply with the study requirements.
  • Accessible by telephone.

Exclusion Criteria:

  • Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days.
  • Allergy to copper, or Wilson's disease (for Paragard; may have Mirena)
  • Intracavitary of symptomatic uterine fibroids.
  • Ovarian, cervical or endometrial cancer.
  • Severe anemia (defined as hgb < 8).
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00621543
Dr. Sarah J. Betstadt, Boston University
H-24902, H-24902
Boston University
University of Utah
Principal Investigator: Sarah J Betstadt, MD Boston University
Study Director: Lynn Borgatta, MD, MPH Boston University
Boston University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP