Clinical Study on a Novel Anti-adhesion Barrier Film
- Conditions
- Intrauterine Adhesion
- Interventions
- Device: anti-adhesion diaphragm
- Registration Number
- NCT05888545
- Lead Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Brief Summary
The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1176
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description anti-adhesion diaphragm anti-adhesion diaphragm Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.
- Primary Outcome Measures
Name Time Method Incidence of uterine adhesions in the 3rd postoperative menstrual cycle. one week before the third menstrual cycle post-index procedure 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.
- Secondary Outcome Measures
Name Time Method Patient comfort after placement checklist three months (third menstrual cycle) post-index procedure classified as comfortable, general, uncomfortable, and very uncomfortable.
Postoperative Menstrual time（days） two week, three months (third menstrual cycle) post-index procedure Postoperative Menstrual time（days）
Patient acceptance chaecklist three months (third menstrual cycle) post-index procedure willingness to use again and to recommend others;
bleeding volume (Normal, decrease, increase) two week, three months (third menstrual cycle) post-index procedure Menstruation
Abdominal pain two week, three months (third menstrual cycle) post-index procedure Abdominal pain due to postoperative menstruation
Physician satisfaction checklist three months (third menstrual cycle) post-index procedure classified as very satisfied, satisfied, general and unsatisfied;
Trial Locations
- Locations (8)
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, Zhejiang, China
Quzhou People's Hospital
🇨🇳Quzhou, Zhejiang, China
Lishui Hospital of TCM
🇨🇳Lishui, Zhejiang, China
Lishui People's Hospital
🇨🇳Lishui, Zhejiang, China
The Second People's Hospital Of Quzhou, Zhejiang
🇨🇳Quzhou, Zhejiang, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Yiwu, Zhejiang, China
Yuyao People's Hospital of Zhejiang Province
🇨🇳Yuyao, Zhejiang, China
Wenzhou Central Hospital
🇨🇳Wenzhou, Zhejiang, China