Insertion of an Intrauterine Device (IUD) After Medical Abortion

This study has been completed.
Sponsor:
Collaborator:
University of Utah
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00621543
First received: January 28, 2008
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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 Intervention
Intrauterine Device Expulsion
Medical Abortion
Induced Abortion
Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insertion of an IUD After Medical Abortion

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Women Continuing IUD Use at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621543

Locations
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
Investigators
Principal Investigator: Sarah J Betstadt, MD Boston University
Study Director: Lynn Borgatta, MD, MPH Boston University
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Sarah J. Betstadt, Boston University
ClinicalTrials.gov Identifier: NCT00621543     History of Changes
Other Study ID Numbers: H-24902, H-24902
Study First Received: January 28, 2008
Results First Received: April 4, 2011
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Copper
Levonorgestrel
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 31, 2014