None listed
Conditions
Interventions
Treatment group:Anti-adhesion diaphragm of uterine cavity
Control group:Disposable balloon uterine stent (Uterine mobility barrier)
Sponsors
Hospital of Obstetrics and Gynecology, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this experiment and sign a written informed consent; 2.18= age =45 years old female; 3. 6-8 weeks of pregnancy abortion or Qinggong surgery patients or high-risk abortion; 4. Regular menstruation.
Exclusion criteria
Exclusion criteria: 1.have a history of severe allergies; 2. Uterine inflammation and infection have been diagnosed in the past 3 months; 3. Suppurative infection of vagina, cervix or uterus; 4.acute pelvic inflammatory disease, acute vaginitis patients; 5. Patients with serious systemic diseases; 6. Patients with malignant tumors; 7.cervical insufficiency or uterine prolapse; 8.unexplained vaginal bleeding; 9. Genital organ malformation, submucosal myoma, abnormal uterine flexion after cesarean section; 10. People with mental and nervous system diseases; 11.heart valve disease with complications; 12. there is a history of adhesion (diagnosed); 13. Patients with significant reduction of menstruation after abortion in the past; 14. Participants in other medical device clinical trials or drug clinical trials within three months; 15. Patients who are considered unfit to participate in this clinical trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adhesion in the third postoperative menstrual cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether the product packaging is in good condition;Problems and defects found in the use of the product;Whether it is convenient to place the uterine cavity anti-adhesion diaphragm and whether the installation is smooth;The time required to place the uterine cavity anti-adhesion diaphragm;Degree of adhesion; | — |
Countries
China
Contacts
Public ContactXu Jian
Hospital of Obstetrics and Gynecology, Zhejiang University School of Medicine
Outcome results
None listed