A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intrauterine Adhesion
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Enrollment
- 1176
- Locations
- 8
- Primary Endpoint
- Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
Time Frame: 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 Outcomes
- Patient comfort after placement checklist(three months (third menstrual cycle) post-index procedure)
- Postoperative Menstrual time（days）(two week, three months (third menstrual cycle) post-index procedure)
- Patient acceptance chaecklist(three months (third menstrual cycle) post-index procedure)
- bleeding volume (Normal, decrease, increase)(two week, three months (third menstrual cycle) post-index procedure)
- Abdominal pain(two week, three months (third menstrual cycle) post-index procedure)
- Physician satisfaction checklist(three months (third menstrual cycle) post-index procedure)