Misoprostol With Intrauterine Device Insertion

February 4, 2013 updated by: Alison Edelman, Oregon Health and Science University

Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97206
        • Planned Parenthood of the Columbia Willamette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
Cervical preparation with misoprostol prior to intrauterine device insertion
Drug: Misoprostol
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
Other Names:
  • prostaglandin
Placebo Comparator: Placebo
Cervical preparation with placebo prior to intrauterine device insertion
Dietary supplement: Magnesium Oxide
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
Other Names:
  • Placebo
  • Magnesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
Time Frame: 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).
Time of IUD insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).
Time Frame: 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).
At time of IUD insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU RES 3489

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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