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

Contraception Clinical Trial

— miso  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147497
• Other study ID #: IRB00021303
• Secondary ID: MISO Emory
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: January 10, 2018
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

Description:

There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18 years

• negative pregnancy test

• no prior pregnancy beyond 19 6/7 weeks

• no pelvic inflammatory disease in last 3 months

• no current cervicitis

• willing to follow up in 1-2 months

Exclusion Criteria:

• active cervical infection

• current pregnancy

• prior pregnancy beyond 19 6/7 weeks

• uterine anomaly

• fibroid uterus distorting uterine cavity

• copper allergy or wilson's disease for ParaGard

• undiagnosed abnormal uterine bleeding

• cervical or uterine cancer

• sepsis associated with the most recent pregnancy

• current breast cancer for levonogestrel IUD

• inflammatory bowel disease

• allergy to misoprostol

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Misoprostol
400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
• Placebo
Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

Locations

Country	Name	City	State
United States	The Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

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	The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).	assessed immediately post IUD insertion
Secondary	Patient Perceived Pain on a 100 Point Visual Analogue Scale	The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).	immediately after insertion
Secondary	The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD		assessed immediately after IUD insertion
Secondary	Time for Insertion Procedure		assessed immediately after IUD insertion
Secondary	Acceptability of Discomfort Associated With Insertion		assessed at one week after insertion and at one month after insertion
Secondary	Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women		assessed immediately following insertion
Secondary	Need for Additional Pain Medications After Insertion of the IUD		assessed one week after insertion