N/A
Completed N=40
Misoprostol With Intrauterine Device Insertion
Source: ClinicalTrials.gov NCT00613366 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). — 24; 29 mm
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.
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 | — |
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)
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. Informational only — not medical advice.