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Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

NCT ID: NCT02474433

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-07-31

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.

Detailed Description

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Conditions

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Cervical Preparation Prior to Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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PO Misoprostol

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

Group Type ACTIVE_COMPARATOR

Misoprostol (Cytotec)

Intervention Type DRUG

PV Misoprostol

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

Group Type ACTIVE_COMPARATOR

Misoprostol (Cytotec)

Intervention Type DRUG

Buccal Misoprostol

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

Group Type ACTIVE_COMPARATOR

Misoprostol (Cytotec)

Intervention Type DRUG

Interventions

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Misoprostol (Cytotec)

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hadas Ganer Herman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Edith Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hadas Ganer Herman, MD

Role: CONTACT

Phone: 972526206696

Email: [email protected]

Facility Contacts

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Hadas Ganer Herman, MD

Role: primary

References

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Ganer Herman H, Kerner R, Gluck O, Feit H, Keidar R, Bar J, Sagiv R. Different Routes of Misoprostol for Same-Day Cervical Priming Prior to Operative Hysteroscopy: A Randomized Blinded Trial. J Minim Invasive Gynecol. 2017 Mar-Apr;24(3):455-460. doi: 10.1016/j.jmig.2016.12.024. Epub 2017 Jan 7.

Reference Type DERIVED
PMID: 28069480 (View on PubMed)

Other Identifiers

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0083-15-WOMC

Identifier Type: -

Identifier Source: org_study_id