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

Sex

FEMALE

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cervical dilatation

Timeframe: four hours after misoprostol use

Trial details

NCT IDNCT03490617

SponsorInstituto Materno Infantil Prof. Fernando Figueira

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-11

View on ClinicalTrials.gov More Family Planning trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.