Intrauterine Adhesion
Conditions
Keywords
Induced abortion, IUA, anti-adhesion barrier film
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.
Interventions
DEVICEanti-adhesion diaphragm
Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| bleeding volume (Normal, decrease, increase) | two week, three months (third menstrual cycle) post-index procedure | Menstruation |
| Postoperative Menstrual time（days） | two week, three months (third menstrual cycle) post-index procedure | Postoperative Menstrual time（days） |
| 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; |
| Patient acceptance chaecklist | three months (third menstrual cycle) post-index procedure | willingness to use again and to recommend others; |
| Patient comfort after placement checklist | three months (third menstrual cycle) post-index procedure | classified as comfortable, general, uncomfortable, and very uncomfortable. |
Other
| Measure | Time frame | Description |
|---|---|---|
| body temperature ( ℃) | three months (third menstrual cycle) post-index procedure | Vital signs |
| breathing (Times/minute) | three months (third menstrual cycle) post-index procedure | Vital signs |
| blood pressure (mmHg) | three months (third menstrual cycle) post-index procedure | Vital signs |
| heart rate ( Times/minute) | three months (third menstrual cycle) post-index procedure | Vital signs |
| adverse reactions or adverse events | three months (third menstrual cycle) post-index procedure | adverse events |
| Number of Participants With Abnormal Laboratory Values | three months (third menstrual cycle) post-index procedure | Abnormal Laboratory Values |
Countries
China
Contacts
Primary ContactJian Xu, PhD
Outcome results
None listed