Misoprostol With Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.

Detailed Description
-----------------
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.

Official Title
-----------------
Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion

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

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Dietary Supplement: Magnesium Oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation) Ages 18-45 Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette Exclusion Criteria: Pregnancy occurring less than 6 weeks from time of presentation History of prior intrauterine device placement History of Mullerian tract anomalies History of uterine surgery Allergy or intolerance to misoprostol or other prostaglandin Pelvic inflammatory disease (current or within the past 3 months) Sexually transmitted diseases (current) Puerperal or postabortion sepsis (current or within the past 3 months) Purulent cervicitis (current) Undiagnosed abnormal vaginal bleeding Malignancy of the genital tract Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>Cervical preparation with misoprostol prior to intrauterine device insertion | Drug: Misoprostol<br>* Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.<br>* Other names: prostaglandin;|
| Placebo Comparator: Placebo<br>Cervical preparation with placebo prior to intrauterine device insertion | Dietary Supplement: Magnesium Oxide<br>* Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). | Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right). | Time of IUD insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS). | Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right). | At time of IUD insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine device, cervical dilation, nulliparous women, pain management