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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001897
• Other study ID #: 09004201
• Status: Completed
• Phase: N/A
• First received: October 26, 2009
• Last updated: June 13, 2012
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Misoprostol
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
• Placebo
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Locations

Country	Name	City	State
United States	University Medical Center Ob/Gyn clinic 8OPC	Tucson	Arizona
United States	UPH-Kino multispecialty clinic	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale		after IUD insertion
Secondary	Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia		during IUD insertion
Secondary	Side effects of medications		prior to IUD insertion
Secondary	Provider perceived ease of insertion on a 100 mm visual analogue scale		after IUD insertion
Secondary	Acceptability of wait time prior to IUD placement		1 week after IUD insertion
Secondary	Procedure complications		Up to 1 month after IUD placement
Secondary	Acceptability of total IUD placement process, would you recommend this to a friend?		1 week and 1 month after IUD insertion