Laminaria and Misoprostol Before Operative Hysteroscopy

Phase 2

• Conditions: Cervical Spasm
• Interventions: Device: Laminaria tent; Drug: Laminaria plus Misoprostol

• Registration Number: NCT03388827
• Lead Sponsor: Zagazig University

Brief Summary

Laminaria and Misoprostol before Operative Hysteroscopy

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 Timeline

• Status Verified: 2017-12
• Study Start: 2017-12-20
• Study First Submitted: 2017-12-25
• Study First Submitted QC: 2017-12-25
• Study First Posted: 2018-01-03
• Primary Completion: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

nullipara

• need hystroscopic intervention

Exclusion Criteria

previous pregnancy

cervical lesion

contraindication to misoprostol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laminaria	Laminaria tent	Laminaria tent was introduced in the cervical canal
Laminaria plus Misoprostol	Laminaria plus Misoprostol	Laminaria and Misoprostol were introduced

Primary Outcome Measures

Name	Time	Method
Preoperative cervical width	12 hours	cervical width in Hegar dilators number

Secondary Outcome Measures

Name	Time	Method
adverse effects	24 hours	adverse effects of the method used or hysteroscopy

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig ,, Egypt