Insertion of an Intrauterine Device (IUD) After Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621543
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : July 8, 2011
Last Update Posted : July 14, 2011
University of Utah
Information provided by:
Boston University

Brief Summary:

The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (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 or disease Intervention/treatment Phase
Intrauterine Device Expulsion Medical Abortion Induced Abortion Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS] Not Applicable

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 intreatuereine device (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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insertion of an IUD After Medical Abortion
Study Start Date : March 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Observation- All subjects
Women choosing intra-uterine contraception after medical abortion.
Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) 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 Food and Druga Administration (FDA) instructions.
Other Name: IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUS

Primary Outcome Measures :
  1. Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Percentage of Women Continuing IUD Use at 3 Months [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621543

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Boston University
University of Utah
Principal Investigator: Sarah J Betstadt, MD Boston University
Study Director: Lynn Borgatta, MD, MPH Boston University

Additional Information:

Responsible Party: Dr. Sarah J. Betstadt, Boston University Identifier: NCT00621543     History of Changes
Other Study ID Numbers: H-24902
First Posted: February 22, 2008    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Boston University:
Intrauterine Device
Induced Abortion
Medical Abortion

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Growth Substances