Misoprostol For Nulliparous Women Before Hysteroscopy

Phase 3

• Conditions: Cervical Ripening
• Interventions: Drug: oral misoprostol; Drug: misoprostol

• Registration Number: NCT01156948
• Lead Sponsor: Wenzhou Medical University

Brief Summary

To compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Detailed Description

There is no consensus on the effect of misoprostol on cervical ripening for nulliparous women. The aim of the study is to compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Study Timeline

• Status Verified: 2008-05
• Study Start: 2008-05
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Last Update Submitted: 2010-07-07
• Last Update Posted: 2010-07-08
• Primary Completion: 2010-08
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.

Exclusion Criteria

• women with a known allergy to misoprostol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral misoprostol	oral misoprostol	oral misoprostol
vaginal misoprostol	misoprostol	vaginal misoprostol was administered to this group of nulliparous women

Primary Outcome Measures

Name	Time	Method
cervical width	one day

Secondary Outcome Measures

Name	Time	Method
side effects	one day

Trial Locations

Locations (1)

the 1st Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China