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

Launched by BIOREGEN BIOMEDICAL (CHANGZHOU) CO., LTD · Nov 23, 2017

Keywords

ClinConnect Summary

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.

Mea...

Gender

FEMALE

Eligibility 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.