Misoprostol With Intrauterine Device Insertion

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Contraception

Treatments: Drug: Misoprostol; Dietary Supplement: Magnesium Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT00613366

OHSU RES 3489

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

Cervical preparation with misoprostol prior to intrauterine device insertion

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Description:

Cervical preparation with placebo prior to intrauterine device insertion

Treatment:

Dietary Supplement: Magnesium Oxide