Insertion of an Intrauterine Device (IUD) After Medical Abortion

Medical Abortion Clinical Trial

Official title:

Insertion of an IUD After Medical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621543
• Other study ID #: H-24902
• Secondary ID: H-24902
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: July 12, 2011
• Start date: March 2006
• Est. completion date: September 2008

Study information

• Verified date: July 2011
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induced Abortion
• Intrauterine Device Expulsion
• Medical Abortion

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.		Three months	No
Secondary	Percentage of Women Continuing IUD Use at 3 Months		3 months	No

External Links

•   Intrauterine Devices. The Mayo Clinic
•   Reproductive health policy and advocacy organization