NCT00621543

Insertion of an Intrauterine Device (IUD) After Medical Abortion

Insertion of an IUD After Medical Abortion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intrauterine Device Expulsion
• Medical Abortion
• Induced Abortion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-05-01
• Completion: 2008-09-01
• First posted: 2008-02-22
• Last updated: 2011-07-14
• Results posted: 2011-07-08

Locations

2 sites across 1 country: United States