Misoprostol With Intrauterine Device Insertion

Not Applicable

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Placebo	Magnesium Oxide	Cervical preparation with placebo prior to intrauterine device insertion
Misoprostol	Misoprostol	Cervical preparation with misoprostol prior to intrauterine device insertion

Primary Outcome Measures

Name	Time	Method
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).	Time of IUD insertion	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).

Secondary Outcome Measures

Name	Time	Method
Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).	At time of IUD insertion	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).

Locations (2): Planned Parenthood of the Columbia Willamette
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Portland, Oregon, United States
Oregon Health & Science University
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Portland, Oregon, United States