Misoprostol With Intrauterine Device Insertion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Misoprostol

Cervical preparation with misoprostol prior to intrauterine device insertion

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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

Placebo

Cervical preparation with placebo prior to intrauterine device insertion

Group Type PLACEBO_COMPARATOR

Magnesium Oxide

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Misoprostol

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

Intervention Type DRUG

Magnesium Oxide

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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prostaglandin Magnesium Placebo

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes