Misoprostol For Nulliparous Women Before Hysteroscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Wenzhou Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01156948
First received: July 2, 2010
Last updated: July 7, 2010
Last verified: May 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • side effects [ Time Frame: one day ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   16 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Feng Lin, the 1st Affiliated Hospital of Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01156948     History of Changes
Other Study ID Numbers: WenzhouMC
Study First Received: July 2, 2010
Last Updated: July 7, 2010
Health Authority: China: the 1st Affiliated Hospital of Wenzhou Medical College

Keywords provided by Wenzhou Medical University:
misoprostol
nulliparous
hysteroscopy

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

ClinicalTrials.gov processed this record on July 24, 2014