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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in 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 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.

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 400 micrograms inserted vaginally or buccally, per the participants desire. | Drug: Misoprostol<br>* 400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.<br>* Other names: Cytotec;|
| Placebo Comparator: Placebo<br>Pills which are identical to the study drug in appearance, taste, and smell. | Drug: Placebo<br>* Pills which are identical to the study drug in appearance, taste, and smell.<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 (VAS) | VAS (anchors: 0 = extremely easy, 100 mm= impossible) | Immediately post IUD insertion | 

Secondary Outcome Measures

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

 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