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

Not Applicable

Completed

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

• Registration Number: NCT01001897
• Lead Sponsor: University of Arizona

Brief 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2011-01
• Study Completion: 2011-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• Nulliparous, no prior pregnancy beyond 14 week
• Over 18 years of age
• Negative pregnancy test

Exclusion Criteria

• current pregnancy or pregnancy within 6 weeks
• current cervicitis or PID (active or within 3 months)
• undiagnosed abnormal uterine bleeding
• allergy to copper/ Wilson's disease (for Paragard)
• cervical or uterine cancer
• uterine anomaly altering uterine cavity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion
misoprostol	Misoprostol	400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale	after IUD insertion

Secondary Outcome Measures

Name	Time	Method
Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia	during IUD insertion
Side effects of medications	prior to IUD insertion
Provider perceived ease of insertion on a 100 mm visual analogue scale	after IUD insertion
Acceptability of wait time prior to IUD placement	1 week after IUD insertion
Procedure complications	Up to 1 month after IUD placement
Acceptability of total IUD placement process, would you recommend this to a friend?	1 week and 1 month after IUD insertion

Trial Locations

Locations (2)

UPH-Kino multispecialty clinic; 🇺🇸 Tucson, Arizona, United States

University Medical Center Ob/Gyn clinic 8OPC; 🇺🇸 Tucson, Arizona, United States