Clinical Study on a Novel Anti-adhesion Barrier Film

The Fourth Affiliated Hospital of Zhejiang University School of Medicine1,176 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,176

Conditions

Intrauterine Adhesion

Interventions

anti-adhesion diaphragmDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (8)

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

NOT_YET_RECRUITING

Lishui Hospital of TCM

Lishui, Zhejiang, China

NOT_YET_RECRUITING

Lishui People's Hospital

Lishui, Zhejiang, China

Outcomes

Primary Outcomes

Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.

The incidence of uterine adhesions was defined as the incidence of uterine adhesions in the control group of subjects with the uterine anti-adhesion septum placed to block the anterior and posterior uterine wall contact, and the incidence of adhesions in both groups was evaluated by ultrasound and/or hysteroscopy in the 3rd postoperative menstrual cycle.

Time frame: one week before the third menstrual cycle post-index procedure

Secondary Outcomes

bleeding volume (Normal, decrease, increase)

Menstruation

Time frame: two week, three months (third menstrual cycle) post-index procedure

Postoperative Menstrual time（days）

Time frame: two week, three months (third menstrual cycle) post-index procedure

Abdominal pain

Abdominal pain due to postoperative menstruation

Time frame: two week, three months (third menstrual cycle) post-index procedure

Physician satisfaction checklist

classified as very satisfied, satisfied, general and unsatisfied;

Time frame: three months (third menstrual cycle) post-index procedure

Patient acceptance chaecklist

willingness to use again and to recommend others;

Time frame: three months (third menstrual cycle) post-index procedure

Patient comfort after placement checklist

classified as comfortable, general, uncomfortable, and very uncomfortable.

Central Contacts

Jian Xu, PhD

CONTACT

18867961080 xuj@zju.edu.cn

Data from ClinicalTrials.gov

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