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Misoprostol For Nulliparous Women Before Hysteroscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Wenzhou Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156948
First Posted: July 5, 2010
Last Update Posted: July 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wenzhou Medical University
  Purpose
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.

Condition Intervention Phase
Cervical Ripening Drug: misoprostol Drug: oral misoprostol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Vaginal Versus Oral Misoprostol for Nulliparous Women Prior to Operative Hysteroscopy

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • cervical width [ Time Frame: one day ]

Secondary Outcome Measures:
  • side effects [ Time Frame: one day ]

Estimated Enrollment: 120
Study Start Date: May 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vaginal misoprostol
vaginal misoprostol was administered to this group of nulliparous women
Drug: misoprostol
400ug vaginally the day before surgery
Experimental: oral misoprostol
oral misoprostol
Drug: oral misoprostol
400ug misoprostol orally the day before the surgery

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156948


Locations
China, Zhejiang
the 1st Affiliated Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Feng Lin, MD       linfeng983023@hotmail.com   
Principal Investigator: Feng Lin, MD         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Feng Lin the 1st affiliated hospital of Wenzhou Medical College
  More Information

Responsible Party: Feng Lin, the 1st Affiliated Hospital of Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01156948     History of Changes
Other Study ID Numbers: WenzhouMC
First Submitted: July 2, 2010
First Posted: July 5, 2010
Last Update Posted: July 8, 2010
Last Verified: May 2008

Keywords provided by Wenzhou Medical University:
misoprostol
nulliparous
hysteroscopy

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics