Insertion of an Intrauterine Device (IUD) After Medical Abortion

NCT00621543 | Completed Results

• 1 other identifier: H-24902
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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).

Conditions

Intrauterine Device Expulsion; Medical Abortion; Induced Abortion

Keywords

Intrauterine Device; Induced Abortion; Medical Abortion

Outcome Measures

Primary Outcomes (1)

• Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.

  Three months

Secondary Outcomes (1)

• Percentage of Women Continuing IUD Use at 3 Months

  3 months

Study Arms (1)

Observation- All subjects

EXPERIMENTAL

Women choosing intra-uterine contraception after medical abortion.

Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]

Interventions

IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS] DEVICE

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.

Also known as: IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUS

Observation- All subjects

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston University: lead
• University of Utah: collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (8)

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

  PMID: 8853278 BACKGROUND

• Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. doi: 10.1016/j.contraception.2004.01.009.

  PMID: 15157788 BACKGROUND

• Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005 Apr;192(4):998-1004. doi: 10.1016/j.ajog.2004.12.091.

  PMID: 15846172 BACKGROUND

• Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzman-Rodriguez 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. doi: 10.1056/NEJMoa010438.

  PMID: 11529209 BACKGROUND

• 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. doi: 10.1783/147118904322701956.

  PMID: 15006311 BACKGROUND

• 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. doi: 10.1016/s0010-7824(02)00518-8.

  PMID: 12618259 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2003.00264.x.

  PMID: 11762657 BACKGROUND

• Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000 Mar 30;342(13):946-56. doi: 10.1056/NEJM200003303421307.

  PMID: 10738054 BACKGROUND

Related Links

• Intrauterine Devices. The Mayo Clinic

Limitations and Caveats

21 women did not return for the 3 months follow-up. Some of the 21 women were contacted earlier 3 months, and none had had an expulsion. 2 women were ineligible at the first visit.

Results Point of Contact

• Title: Sarah Betstadt, MD, MPH
• Organization: University of Rochester

sarah_betstadt@urmc.rochester.edu

585-276-5368

Study Officials

• Sarah J Betstadt, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Lynn Borgatta, MD, MPH

  Boston University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 14, 2011
• Results First Posted: July 8, 2011

Record last verified: 2011-07

Locations

US (2)