Misoprostol With Intrauterine Device Insertion

• ClinicalTrials.gov Identifier: NCT00613366
• Recruitment Status: Completed
• First Posted: February 13, 2008
• Results First Posted: March 15, 2013
• Last Update Posted: March 15, 2013
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): Alison Edelman, Oregon Health and Science University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Contraception	Drug: Misoprostol; Dietary Supplement: Magnesium Oxide	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• 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
• Study Start Date: June 2007
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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).

Eligibility Criteria

• 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

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

Additional Information:

(Women's Health Research Unit website) 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.

• Responsible Party: Alison Edelman, MD MPH, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00613366
• Other Study ID Numbers: OHSU RES 3489
• First Posted: February 13, 2008
• 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