Laminaria and Misoprostol Before Operative Hysteroscopy

Cervical Spasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388827
• Other study ID #: ZUH- 9
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2017
• Est. completion date: January 2019

Study information

• Verified date: December 2017
• Source: Zagazig University
• Contact: ibrahim A EL sharkwy
• Phone: 00966554818576
• Email: ibrahimsharkwy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laminaria and Misoprostol before Operative Hysteroscopy

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria: nullipara

• need hystroscopic intervention

Exclusion Criteria: previous pregnancy

cervical lesion

contraindication to misoprostol

Related Conditions & MeSH terms

• Cervical Spasm

Intervention

Device:
• Laminaria tent
Laminaria tent was inserted for 12 hours before Hysteroscopy

Drug:
• Laminaria plus Misoprostol
Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig ,

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative cervical width	cervical width in Hegar dilators number	12 hours
Secondary	adverse effects	adverse effects of the method used or hysteroscopy	24 hours