N/A N=40 Randomized Quadruple-blind Supportive Care

Misoprostol With Intrauterine Device Insertion

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT00613366 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). — 24; 29 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Misoprostol (Drug); Magnesium Oxide (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).	24; 29	—
SECONDARY Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).	65; 55	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00613366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.