Clinical trial NCT00621543: Insertion of an Intrauterine Device (IUD) After Medical Abortion
Official title: Insertion of an IUD After Medical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Device Expulsion
Medical Abortion
Induced Abortion
Keywords: Intrauterine Device
Induced Abortion
Medical Abortion
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2008-02-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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).

Primary outcomes:
measure: Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
timeFrame: Three months
Secondary outcomes:
measure: Percentage of Women Continuing IUD Use at 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Boston University
name: Sarah J Betstadt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Lynn Borgatta, MD, MPH
role: STUDY_DIRECTOR
References:
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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. doi: 10.1016/j.ajog.2004.12.091.
citation: 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.
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. doi: 10.1783/147118904322701956.
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. doi: 10.1016/s0010-7824(02)00518-8.
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. doi: 10.1111/j.1471-0528.2003.00264.x.
citation: 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.