Misoprostol With Intrauterine Device Insertion
This study has been completed.
Sponsor:
Oregon Health and Science University
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
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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:
|
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
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
Additional 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 Antacids Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents |
Therapeutic Uses Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013