Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 4

Conditions: Cervical Preparation Prior to Hysteroscopy

Treatments: Drug: Misoprostol (Cytotec)

Study type: Interventional

Funder types: Other

Identifiers

NCT02474433

0083-15-WOMC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

PO Misoprostol

Active Comparator group

Description:

Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy

Treatment:

Drug: Misoprostol (Cytotec)

PV Misoprostol

Active Comparator group

Description:

Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy

Treatment:

Drug: Misoprostol (Cytotec)

Buccal Misoprostol

Active Comparator group

Description:

Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy

Treatment:

Drug: Misoprostol (Cytotec)