Clinical trial NCT00613366: Misoprostol With Intrauterine Device Insertion
Official title: Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: intrauterine device
cervical dilation
nulliparous women
pain management
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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)

Primary outcomes:
measure: The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
timeFrame: Time of IUD insertion
Secondary outcomes:
measure: Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).
timeFrame: At time of IUD insertion
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood of the Columbia Willamette
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.