Misoprostol With Intrauterine Device Insertion

Contraception Clinical Trial

Official title:

Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613366
• Other study ID #: OHSU RES 3489
• Status: Completed
• Phase: N/A
• First received: January 29, 2008
• Last updated: February 4, 2013
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Misoprostol
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Dietary Supplement:
• Magnesium Oxide
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	Planned Parenthood of the Columbia Willamette	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).	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	No
Secondary	Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).	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	No