Misoprostol With Intrauterine Device Insertion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00613366
First received: January 29, 2008
Last updated: February 4, 2013
Last verified: February 2013
  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: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613366

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

No publications provided by Oregon Health and Science University

Additional 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
Study First Received: January 29, 2008
Results First Received: June 1, 2012
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014