Laminaria and Misoprostol Before Operative Hysteroscopy

December 6, 2018 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

The Use of Laminaria Versus Laminaria Plus Misoprostol Before Operative Hysteroscopy in Nulliparous Women . A Double Blinded Randomized Trial.

Laminaria and Misoprostol before Operative Hysteroscopy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: nullipara

  • need hystroscopic intervention

Exclusion Criteria: previous pregnancy

cervical lesion

contraindication to misoprostol

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laminaria
Laminaria tent was introduced in the cervical canal
Device: Laminaria tent
Laminaria tent was inserted for 12 hours before Hysteroscopy
Active Comparator: Laminaria plus Misoprostol
Laminaria and Misoprostol were introduced
Drug: Laminaria plus Misoprostol
Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy
Other Names:
  • cytotec,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative cervical width
Time Frame: 12 hours
cervical width in Hegar dilators number
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effects
Time Frame: 24 hours
adverse effects of the method used or hysteroscopy
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

December 25, 2017

First Submitted That Met QC Criteria

December 25, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZUH- 9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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