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The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion

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ClinicalTrials.gov Identifier: NCT03353909
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
BioRegen Biomedical (CHangzhou) Co., Ltd

Brief Summary:
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Device: new crosslinked hyaluronan gel Not Applicable

Detailed Description:

Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of A New Crosslinked Hyaluronan Gel in the Prevention of Postoperative Intrauterine Adhesion After Dilatation and Curettage in Women With Delayed Miscarriage: A Prospective, Randomized, Controlled Trial
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions Aneurysms

Arm Intervention/treatment
Experimental: 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.
Device: new crosslinked hyaluronan gel
At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
Other Name: MateRegen Gel

No Intervention: Control
At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.



Primary Outcome Measures :
  1. Incidence of intrauterine adhesion [ Time Frame: 3 months after dilatation and curettage ]
    The number of women with intrauterine adhesion


Secondary Outcome Measures :
  1. The adhesion scores of extent of uterine cavity involved [ Time Frame: 3 months after dilatation and curettage ]
    Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (<1/3 cavity with adhesion), 2 points (1/3-2/3 cavity with adhesion) and 4 points (>2/3 cavity with adhesion), high values represent worse outcome

  2. The adhesion scores of type of adhesion [ Time Frame: 3 months after dilatation and curettage ]
    Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (filmy adhesion), 2 points (filmy & dense adhesion) and 4 points (dense adhesion), high values represent worse outcome

  3. The adhesion scores of menstrual pattern [ Time Frame: 3 months after dilatation and curettage ]
    Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 0 point (normal), 2 points (hypomenorrhea) and 4 points (amenorrhea), high values represent worse outcome

  4. Cumulative adhesion score [ Time Frame: 3 months after dilatation and curettage ]
    The summed score of the adhesion scores of extent of uterine cavity involved, type of adhesion and menstrual pattern; range: 1-12 points, high values represent worse outcome

  5. Severity [ Time Frame: 3 months after dilatation and curettage ]
    Graded according to cumulative adhesion score: Stage I (mild)(1-4 points), Stage II (moderate)(5-8 points) and Stage III (severe)(9-12 points).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

The inclusion criteria:

  • Patients to be female, aged 18-45 years
  • 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.

The exclusion criteria:

  • Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives
  • 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.
  Study Documents (Full-Text)

Documents provided by BioRegen Biomedical (CHangzhou) Co., Ltd:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BioRegen Biomedical (CHangzhou) Co., Ltd
ClinicalTrials.gov Identifier: NCT03353909     History of Changes
Other Study ID Numbers: FNL-2016-03
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioRegen Biomedical (CHangzhou) Co., Ltd:
Intrauterine adhesion
Delayed miscarriage
hyaluronan gel
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents