Clinical Study on a Novel Anti-adhesion Barrier Film

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

Detailed Description
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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.

Official Title
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A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Device: anti-adhesion diaphragm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-adhesion diaphragm<br>Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. | Device: anti-adhesion diaphragm<br>* Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.<br>|
| No Intervention: control group<br>Participants will be treated routinely with no other interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one week before the third menstrual cycle post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding volume (Normal, decrease, increase) | Menstruation | two week, three months (third menstrual cycle) post-index procedure | 
| Postoperative Menstrual time（days） | Postoperative Menstrual time（days） | two week, three months (third menstrual cycle) post-index procedure | 
| Abdominal pain | Abdominal pain due to postoperative menstruation | two week, three months (third menstrual cycle) post-index procedure | 
| Physician satisfaction checklist | classified as very satisfied, satisfied, general and unsatisfied; | three months (third menstrual cycle) post-index procedure | 
| Patient acceptance chaecklist | willingness to use again and to recommend others; | three months (third menstrual cycle) post-index procedure | 
| Patient comfort after placement checklist | classified as comfortable, general, uncomfortable, and very uncomfortable. | three months (third menstrual cycle) post-index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced abortion, IUA, anti-adhesion barrier film