Laminaria and Misoprostol Before Operative Hysteroscopy
The Use of Laminaria Versus Laminaria Plus Misoprostol Before Operative Hysteroscopy in Nulliparous Women . A Double Blinded Randomized Trial.
1 other identifier
interventional
100
1 country
1
Brief Summary
Laminaria and Misoprostol before Operative Hysteroscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2017
Shorter than P25 for phase_2
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
Study Start
First participant enrolled
December 20, 2017
CompletedFirst Submitted
Initial submission to the registry
December 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedDecember 7, 2018
December 1, 2017
12 months
December 25, 2017
December 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Preoperative cervical width
cervical width in Hegar dilators number
12 hours
Secondary Outcomes (1)
adverse effects
24 hours
Study Arms (2)
Laminaria
EXPERIMENTALLaminaria tent was introduced in the cervical canal
Laminaria plus Misoprostol
ACTIVE COMPARATORLaminaria and Misoprostol were introduced
Interventions
Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy
Eligibility Criteria
You may qualify if:
- need hystroscopic intervention
You may not qualify if:
- cervical lesion
- contraindication to misoprostol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University
Zagazig, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- double blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
December 25, 2017
First Posted
January 3, 2018
Study Start
December 20, 2017
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
December 7, 2018
Record last verified: 2017-12