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

Contraception Clinical Trial

— MPIIN  

Official title:

A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886834
• Other study ID #: 24403
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: December 4, 2014
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)	VAS (anchors: 0 = extremely easy, 100 mm= impossible)	Immediately post IUD insertion	No
Secondary	Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)	VAS; anchors: 0 =none, 100 mm= worst imaginable	prior to insertion, immediately after insertion, and prior to clinic discharge	No