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

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Drug: Misoprostol; Drug: Placebo

• Registration Number: NCT00886834
• Lead Sponsor: University of Utah

Brief Summary

The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Detailed Description

Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2011-08-05
• Results First Submitted QC: 2011-12-21
• Results First Posted: 2011-12-22
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

• 18 years old or older
• negative pregnancy test
• no prior pregnancies beyond 14 6/7 weeks
• no PID in last 3 months
• no current cervicitis
• be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria

• active cervical infection
• current pregnancy
• prior pregnancy beyond 14 weeks gestation
• known uterine anomaly
• fibroid uterus distorting uterine cavity
• copper allergy/Wilson's disease (for Paragard)
• undiagnosed abnormal uterine bleeding
• cervical or uterine cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
Placebo	Placebo	Pills which are identical to the study drug in appearance, taste, and smell.

Primary Outcome Measures

Name	Time	Method
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)	Immediately post IUD insertion	VAS (anchors: 0 = extremely easy, 100 mm= impossible)

Secondary Outcome Measures

Name	Time	Method
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)	prior to insertion, immediately after insertion, and prior to clinic discharge	VAS; anchors: 0 =none, 100 mm= worst imaginable

Trial Locations

Locations (2)

Planned Parenthood Association of Utah; 🇺🇸 Salt Lake City, Utah, United States

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