CompletedPhase 4

Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion

Egypt180 participantsStarted 2020-03-01

Plain-language summary

investigators aim through this study to evaluate and compare the Safety and efficacy of different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of occurrence of adverse effects.

Who can participate

Age range

18 Years – 45 Years

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: * Non-pregnant, * Nulliparous cervix: no previous vaginal delivery or any attempt of vaginal delivery, * Seeking for IUD insertion, * Signing an informed consent to participate in the study, Exclusion Criteria: * Pregnancy or signs of pregnancy, * Signs of cervicitis, * Any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids and intrauterine adhesions, * Women with any kind of pelvic pain, * Abnormal uterine bleeding, * History of cervical surgery,• Vaginal delivery, * Contraindication to misoprostol as allergy, * Administration of any analgesics last 12h, * Withdrawal of consent

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

Pain scores

Timeframe: during insertion of IUCD

Trial details

NCT IDNCT04273984

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-15

View on ClinicalTrials.gov More Intra-uterine Device Complication trials