Insertion of an IUD After Medical Abortion - Full Text View

Sponsors and Collaborators:	Boston University University of Utah
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00621543

Purpose

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
Intrauterine Device Expulsion Medical Abortion Induced Abortion	Device: Copper T-380A or Levonorgestrel IUS

MedlinePlus related topics: Abortion

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Insertion of an IUD After Medical Abortion

Further study details as provided by Boston University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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
Observation- All subjects: Experimental Women choosing intra-uterine contraception after medical abortion.	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.

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.

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

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:

Reproductive health policy and advocacy organization This link exits the ClinicalTrials.gov site

Intrauterine Devices. The Mayo Clinic This link exits the ClinicalTrials.gov site

Publications:

Henshaw SK, Kost K. Abortion patients in 1994-1995: characteristics and contraceptive use. Fam Plann Perspect. 1996 Jul-Aug;28(4):140-7, 158.

Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. Review.

Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005 Apr;192(4):998-1004. Review.

Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzmán-Rodríguez R. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001 Aug 23;345(8):561-7.

Penney G, Brechin S, de Souza A, Bankowska U, Belfield T, Gormley M, Olliver M, Hampton N, Howlett-Shipley R, Hughes S, Mack N, O'Brien P, Rowlands S, Trewinnard K; Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004 Jan;30(1):29-41; quiz 42. Erratum in: J Fam Plann Reprod Health Care. 2004 Apr;30(2):134.

El-Tagy A, Sakr E, Sokal DC, Issa AH. Safety and acceptability of post-abortal IUD insertion and the importance of counseling. Contraception. 2003 Mar;67(3):229-34.

Stanwood NL, Grimes DA, Schulz KF. Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence. BJOG. 2001 Nov;108(11):1168-73. Review.

Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000 Mar 30;342(13):946-56. Review.

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

Keywords provided by Boston University:

Intrauterine Device
Induced Abortion
Medical Abortion

Study placed in the following topic categories:

Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptive Agents, Female
Copper

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Levonorgestrel
Contraceptives, Oral
Physiological Effects of Drugs

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009