Official Title: “Effect of Prophylactic Misoprostol Prior to IUD Insertion”

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

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: April 2008

We 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 IUD. When the participants return for IUD 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 IUD placement.

Intervention(s) in this Clinical Trial

• Drug: Misoprostol
  • Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
• Dietary Supplement: Magnesium Oxide
  • Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• The affect of misoprostol on the ease of IUD placement in nulliparous women.
  • Time Frame: After enrollment is complete
    Safety Issue?: No

Secondary Measures

• The affect of misoprostol on the risk of IUD expulsion in nulliparous women.
  • Time Frame: After enrollment is complete
    Safety Issue?: No

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 IUD (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 IUD 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 (IUD) insertion
• Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

Alison Edelman, M.D., M.P.H Principal Investigator Oregon Health and Science University  

Overall Contact: Women's Health Research Unit Confidential Recruitment Line (503) 494-3666 whru@ohsu.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00613366

Study ID Number: OHSU RES 3489

ClinicalTrials.gov Identifier: NCT00613366

Health Authority: United States: Institutional Review Board

(Women's Health Research Unit website)