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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: misoprostol<br>Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit | Drug: Misoprostol<br>* 400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit<br>|
| Placebo Comparator: placebo<br>Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit | Drug: Placebo<br>* Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD |  | assessed immediately after IUD insertion | 
| Time for Insertion Procedure |  | assessed immediately after IUD insertion | 
| Acceptability of Discomfort Associated With Insertion |  | assessed at one week after insertion and at one month after insertion | 
| Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women |  | assessed immediately following insertion | 
| Need for Additional Pain Medications After Insertion of the IUD |  | assessed one week after insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUD insertion, nulliparous women, contraception, family planning, IUD insertion in nulliparous women