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

Not Applicable

Completed

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

• Registration Number: NCT01307111
• Lead Sponsor: University of New Mexico

Brief Summary

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Detailed Description

The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Results First Submitted: 2015-12-16
• Status Verified: 2016-02
• Results First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Results First Posted: 2016-03-28
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

• 14 years old or older
• Negative pregnancy test
• No prior pregnancies lasting beyond 19 6/7 weeks
• Minimum 2 weeks after spontaneous or medical abortion
• Minimum 4 weeks post 2nd trimester or surgical abortion
• No previous IUD insertions
• No PID in last 3 months
• No current cervicitis
• Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria

• Active cervical infection
• Current pregnancy
• Prior pregnancy beyond 19 6/7 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
Placebo	Placebo	Pills which are identical to the study drug in appearance, taste, and smell.
Misoprostol	Misoprostol	Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.

Primary Outcome Measures

Name	Time	Method
Patient Perceived Pain on a 100-point Visual Analogue Scale.	Prior to insertion, immediately after insertion, and prior to clinic discharge.	Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.

Secondary Outcome Measures

Name	Time	Method
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.	Immediately post IUD insertion	Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).