A Phase 4 interventional study of Misoprostol (Cytotec) in Cervical Preparation Prior to Hysteroscopy, sponsored by Wolfson Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-29.
Sponsored by Wolfson Medical Center · Phase 4, Interventional, and Prevention
This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.
Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Drug: Misoprostol (Cytotec)
Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Drug: Misoprostol (Cytotec)
Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Drug: Misoprostol (Cytotec)
Preoperative cervical width in centimeters
Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.
Time frame: intraoperative
Time required to achieve cervical dilatation
The time in minutes required for dilatation up to a number 10 Hegar
Time frame: intraoperative
Ease of cervical dilatation
The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy)
Time frame: intraoperative
Patient preference
Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)
Time frame: baseline
Adverse effects of medication
Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)
Time frame: baseline
Surgical complications
Complications arising during surgery (perforation, cervical laceration, excess bleeding)
Time frame: intraoperative
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Misoprostol