The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
NCT ID: NCT03353909
Last Updated: 2017-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2016-07-01
2017-02-15
Brief Summary
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Detailed Description
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Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.
Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.
Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Treatment
At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula.
new crosslinked hyaluronan gel
At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
Control
At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.
No interventions assigned to this group
Interventions
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new crosslinked hyaluronan gel
At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Without previous dilatation and curettage
* Undergoing dilatation and curettage for the current delayed miscarriage
* All participants should be with normal liver/rental function and without systemic disease
* Agree to use adequate forms of contraception throughout the study
* Be in good compliance with the follow-up examination according to the study protocol.
Exclusion Criteria
* Genital tract malformation
* Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract
* Suspected genital tuberculosis
* Abnormal blood coagulation
* Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness
* Acute or severe infection
* Autoimmune diseases.
18 Years
45 Years
FEMALE
No
Sponsors
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BioRegen Biomedical (CHangzhou) Co., Ltd
INDUSTRY
Responsible Party
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References
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Li X, Wu L, Zhou Y, Fan X, Huang J, Wu J, Yu R, Lou J, Yang M, Yao Z, Xue M. New Crosslinked Hyaluronan Gel for the Prevention of Intrauterine Adhesions after Dilation and Curettage in Patients with Delayed Miscarriage: A Prospective, Multicenter, Randomized, Controlled Trial. J Minim Invasive Gynecol. 2019 Jan;26(1):94-99. doi: 10.1016/j.jmig.2018.03.032. Epub 2018 Apr 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FNL-2016-03
Identifier Type: -
Identifier Source: org_study_id