Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

Phase 4

• Conditions: Cervical Preparation Prior to Hysteroscopy
• Interventions: Drug: Misoprostol (Cytotec)

• Registration Number: NCT02474433
• Lead Sponsor: Wolfson Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-14
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-17
• Study Start: 2015-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PV Misoprostol	Misoprostol (Cytotec)	Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
PO Misoprostol	Misoprostol (Cytotec)	Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Buccal Misoprostol	Misoprostol (Cytotec)	Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy

Primary Outcome Measures

Name	Time	Method
Preoperative cervical width in centimeters	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 Outcome Measures

Name	Time	Method
Time required to achieve cervical dilatation	intraoperative	The time in minutes required for dilatation up to a number 10 Hegar
Surgical complications	intraoperative	Complications arising during surgery (perforation, cervical laceration, excess bleeding)
Ease of cervical dilatation	intraoperative	The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy)
Patient preference	baseline	Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)
Adverse effects of medication	baseline	Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel