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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

Study Description
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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.

Study Design
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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

Arms and Interventions
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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.


Outcome Measures
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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).


Eligibility Criteria
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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.
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by BioRegen Biomedical (CHangzhou) Co., Ltd:
Study Protocol and Statistical Analysis Plan  [PDF] May 9, 2016

More Information
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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    
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