Misoprostol With Intrauterine Device Insertion

Oregon Health and Science University40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Contraception

Interventions

MisoprostolDRUG

Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Magnesium OxideDIETARY_SUPPLEMENT

Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Planned Parenthood of the Columbia Willamette

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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 frame: Time of IUD insertion

Secondary Outcomes

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).

Time frame: At time of IUD insertion

Data from ClinicalTrials.gov

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