NCT01001897

Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women

A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.

Detailed description

IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Misoprostol	400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
DRUG	Placebo	400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-01-01
• Completion: 2011-04-01
• First posted: 2009-10-27
• Last updated: 2012-06-14

Locations

2 sites across 1 country: United States