Clinical Study on a Novel Anti-adhesion Barrier Film

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Enrolling

Conditions: Intrauterine Adhesion

Treatments: Device: anti-adhesion diaphragm

Study type: Interventional

Funder types: Other

Identifiers

NCT05888545

K2023016

Details and patient eligibility

About

The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.

Full description

The main questions it aims to answer are

• The efficacy of the anti-adhesion diaphragm in preventing intrauterine adhesions;
• The duration of placement of the anti-adhesion septum in the uterus. Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. The control group will receive conventional treatment with no other interventions.

The researchers will compare the two groups to see if it is effective in clinical practice.

Enrollment: 1,176 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntarily participate in this trial and sign a written informed consent;
• Women aged 18 ≤ age ≤ 40 years;
• Those who had an abortion in early pregnancy, and those who had a cleanse.

Exclusion criteria

• Patients with scars;
• Patients with allergies;
• Patients with acute genitourinary tract infections;
• Patients with abnormalities of reproductive organs and abnormal uterine flexion after cesarean section;
• Patients with decreased menstrual flow after previous curettage;
• Patients with previous suspected or diagnosed uterine adhesions;
• Patients on immunosuppressive drugs;
• Patients with long-term use of antibiotics;
• Patients with malignant tumors of the reproductive organs;
• Patients with uterine adenomyosis, endometriosis, and uterine fibroids;
• Patients with severe systemic diseases;
• Patients with other conditions that are not suitable.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,176 participants in 2 patient groups

anti-adhesion diaphragm

Experimental group

Description:

Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.

Treatment:

Device: anti-adhesion diaphragm

control group

No Intervention group

Description:

Participants will be treated routinely with no other interventions.