Misoprostol Prior to IUD Insertion in Nullipara (NCT03490617) | Clinical Trial Compass
CompletedPhase 3
Misoprostol Prior to IUD Insertion in Nullipara
Brazil179 participantsStarted 2009-07
Plain-language summary
The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.
Who can participate
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Nulliparous women
* No chirurgical procedure in the cervix
* Wish to use IUD as a contraceptive method
Exclusion criteria are as follows:
* Presence of active cervical infection visible upon speculum exam (purulent cervicits)
* Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
* Pregnancy ending less than 6 weeks prior to enrollment in study
* History of prior IUD placement
* History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
* History of uterine surgery
* Allergy or intolerance to misoprostol or other prostaglandin
* Undiagnosed abnormal vaginal bleeding
* Malignancy of the genital tract
* Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
* Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)
What they're measuring
1
Cervical dilatation
Timeframe: four hours after misoprostol use
Trial details
NCT IDNCT03490617
SponsorInstituto Materno Infantil Prof. Fernando Figueira