Same-day Cervical Preparation With Misoprostol Before Hysteroscopy
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 29, 2016
April 1, 2016
2 years
June 14, 2015
April 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Time required to achieve cervical dilatation
intraoperative
Ease of cervical dilatation
intraoperative
Patient preference
baseline
Adverse effects of medication
baseline
Surgical complications
intraoperative
Study Arms (3)
PO Misoprostol
ACTIVE COMPARATORPatients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
PV Misoprostol
ACTIVE COMPARATORPatients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Buccal Misoprostol
ACTIVE COMPARATORPatients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Interventions
Eligibility Criteria
You may qualify if:
- Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center
- Written consent supplied
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Edith Wolfson Medical Center
Holon, Israel
Related Publications (1)
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.
PMID: 28069480DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 14, 2015
First Posted
June 17, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
April 29, 2016
Record last verified: 2016-04