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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: misoprostol<br>400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion | Drug: Misoprostol<br>* 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion<br>|
| Placebo Comparator: Placebo<br>Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion | Drug: Placebo<br>* 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale |  | after IUD insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia |  | during IUD insertion | 
| Side effects of medications |  | prior to IUD insertion | 
| Provider perceived ease of insertion on a 100 mm visual analogue scale |  | after IUD insertion | 
| Acceptability of wait time prior to IUD placement |  | 1 week after IUD insertion | 
| Procedure complications |  | Up to 1 month after IUD placement | 
| Acceptability of total IUD placement process, would you recommend this to a friend? |  | 1 week and 1 month after IUD insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IUD insertion, nulliparous women, contraception