Status:
COMPLETED
Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion
Lead Sponsor:
Xiaozheng Shu
Conditions:
Intrauterine Adhesion
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as symptoms such as a...
Eligibility Criteria
Inclusion
- Female patients who are 20-40 years old who is diagnosed as intrauterine adhesion, and did not receive adhesiolysis surgery.
- Patients who signed the informed consent form (ICF) and agreed to take contraceptive measures within 3 months after the surgery.
- Physical examination and routine laboratory tests demonstrated no systemic diseases.
- According to the AFS scoring system on the IUA (1988) only those patients with moderate to severe IUA (i.e. total AFS score larger than 4 points) were enrolled in this clinical trial.
Exclusion
- Patients who is allergic to hyaluronan or its derivatives.
- Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia.
- Patients with malformation of reproductive organs.
- Patients who may not take effective contraceptive measures within 3 months after the surgery. Patients who were suffering severe systemic diseases such as coagulative disorders, cardiovascular diseases and long-term alcoholism and drug abuse were also excluded from this clinical trial.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02220621
Start Date
October 1 2011
Last Update
August 20 2014
Active Locations (3)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
2
The People's Hospital of Hunan Province
Changshu, Hunan, China, 410005
3
The People's Hospital of Chenzhou City,
Chenzhou, Hunan, China, 423000