Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

Study Overview
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Brief Summary
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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.

Official Title
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Same-day Cervical Preparation With Misoprostol Before Hysteroscopy: a Randomized Trial of Different Routes of Administration

Conditions
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Cervical Preparation Prior to Hysteroscopy

Intervention / Treatment
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* Drug: Misoprostol (Cytotec)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PO Misoprostol<br>Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy | Drug: Misoprostol (Cytotec)<br> <br> |
| Active Comparator: PV Misoprostol<br>Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy | Drug: Misoprostol (Cytotec)<br> <br> |
| Active Comparator: Buccal Misoprostol<br>Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy | Drug: Misoprostol (Cytotec)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | intraoperative | 

Secondary Outcome Measures

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