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Misoprostol With Intrauterine Device Insertion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613366
First Posted: February 13, 2008
Last Update Posted: March 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
  Purpose
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.

Condition Intervention
Contraception Drug: Misoprostol Dietary Supplement: Magnesium Oxide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion

Resource links provided by NLM:


Further study details as provided by Alison Edelman, Oregon Health and Science University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 40
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • Magnesium
  • Placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613366


Locations
United States, Oregon
Planned Parenthood of the Columbia Willamette
Portland, Oregon, United States, 97206
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alison Edelman, M.D., M.P.H Oregon Health and Science University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alison Edelman, MD MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00613366     History of Changes
Other Study ID Numbers: OHSU RES 3489
First Submitted: January 29, 2008
First Posted: February 13, 2008
Results First Submitted: June 1, 2012
Results First Posted: March 15, 2013
Last Update Posted: March 15, 2013
Last Verified: February 2013

Keywords provided by Alison Edelman, Oregon Health and Science University:
intrauterine device
cervical dilation
nulliparous women
pain management

Additional relevant MeSH terms:
Misoprostol
Magnesium Oxide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Antacids
Molecular Mechanisms of Pharmacological Action