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 using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 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 buccally or vaginally, per the participants desire. | Drug: Misoprostol<br>* 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.<br>|
| 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 |
| --- | --- | --- |
| Patient Perceived Pain on a 100-point Visual Analogue Scale. | 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. | Prior to insertion, immediately after insertion, and prior to clinic discharge. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Misoprostol, IUD insertion, Nulliparous Women, Contraception, Family Planning, IUD insertion in nulliparous women