Insertion of an Intrauterine Device (IUD) After Medical Abortion

Not Applicable

Completed

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

• Registration Number: NCT00621543
• Lead Sponsor: Boston University

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2008-05
• Study Completion: 2008-09
• Results First Submitted: 2011-04-04
• Results First Submitted QC: 2011-06-10
• Status Verified: 2011-07
• Results First Posted: 2011-07-08
• Last Update Submitted: 2011-07-12
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observation- All subjects	IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]	Women choosing intra-uterine contraception after medical abortion.

Primary Outcome Measures

Name	Time	Method
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.	Three months

Secondary Outcome Measures

Name	Time	Method
Percentage of Women Continuing IUD Use at 3 Months	3 months

Trial Locations

Locations (2)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States