NCT01307111

Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Detailed description

The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Misoprostol	400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
DRUG	Placebo	Pills which are identical to the study drug in appearance, taste, and smell.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2011-03-02
• Last updated: 2016-03-28
• Results posted: 2016-03-28