Misoprostol For Nulliparous Women Before Hysteroscopy
Sponsor
Wenzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01156948
Collaborator
(none)
120
1
2
43
2.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
120 participants
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
Study Start Date
:
May 1, 2008
Anticipated Primary Completion Date
:
Aug 1, 2010
Anticipated Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- cervical width [one day]
Secondary Outcome Measures
- side effects [one day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the 1st Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang | China | 325000 |
Sponsors and Collaborators
- Wenzhou Medical University
Investigators
- Principal Investigator: Feng Lin, the 1st affiliated hospital of Wenzhou Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01156948
Other Study ID Numbers:
- WenzhouMC
First Posted:
Jul 5, 2010
Last Update Posted:
Jul 8, 2010
Last Verified:
May 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: