Misoprostol For Nulliparous Women Before Hysteroscopy

Cervical Ripening Clinical Trial

Official title:

Comparison of Vaginal Versus Oral Misoprostol for Nulliparous Women Prior to Operative Hysteroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01156948
• Other study ID #: WenzhouMC
• Status: Recruiting
• Phase: Phase 3
• First received: July 2, 2010
• Last updated: July 7, 2010
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2008
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: the 1st Affiliated Hospital of Wenzhou Medical College
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening

Intervention

Drug:
• misoprostol
400ug vaginally the day before surgery
• oral misoprostol
400ug misoprostol orally the day before the surgery

Locations

Country	Name	City	State
China	the 1st Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cervical width		one day	Yes
Secondary	side effects		one day	Yes