Same-day Cervical Preparation With Misoprostol Before Hysteroscopy: a Randomized Trial of Different Routes of Administration
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Wolfson Medical Center
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Preoperative cervical width in centimeters
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center
- •Written consent supplied
Exclusion Criteria
- •Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
- •Prostaglandin allergy
- •Pregnancy
- •Genital infection
- •Space-occupying lesion in the endocervical canal
- •Prior cervical surgery
Arms & Interventions
PO Misoprostol
Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Intervention: Misoprostol (Cytotec) (Drug)
PV Misoprostol
Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Intervention: Misoprostol (Cytotec) (Drug)
Buccal Misoprostol
Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Intervention: Misoprostol (Cytotec) (Drug)
Outcomes
Primary Outcomes
Preoperative cervical width in centimeters
Time Frame: intraoperative
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.
Secondary Outcomes
- Time required to achieve cervical dilatation(intraoperative)
- Surgical complications(intraoperative)
- Ease of cervical dilatation(intraoperative)
- Patient preference(baseline)
- Adverse effects of medication(baseline)
Investigators
Hadas Ganer Herman
MD
Wolfson Medical Center