Asherman Syndrome
Conditions
Interventions
Experimental group:Insertion of a balloon uterine stent following missed abortion surgery
Control group:Intrauterine application of cross-linked sodium hyaluronate gel following missed abortion surgery
Sponsors
Shanghai Institute for Biomedical and Pharmaceutical Technologies, Shanghai Institute of Planned Parenthood Research Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age >=20 years and 90 g/L, white blood cell count (WBC. <1.4×10^9/L, with other parameters (e.g), platelets. within normal ranges; 5. Coagulation profile showing no significant abnormalities, with D-dimer levels < 4 times the upper limit of normal; 6. Negative HIV and syphilis (RPR) antibody tests; 7. Electrocardiogram (ECG) without contraindications for anesthesia; 8. Other preoperative examinations normal as per Clinical Guidelines and Technical Specifications: Family Planning Volume (2017 Revised Edition.; 9. Willingness to comply with scheduled follow-up visits and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Contraindications to abortion procedures; 2. History of uterine malformation correction; 3. Previous diagnosis of intrauterine adhesions or suspected adhesions on preoperative evaluation; 4. Patients with polycystic ovary syndrome (PCOS); 5. Patients with adenomyosis; 6. Presence of a single uterine fibroid >5 cm or multiple fibroids; 7. Pregnancy with intrauterine device (IUD) in situ; 8. Active heavy vaginal bleeding requiring emergency curettage; 9. Current pregnancy achieved through assisted reproductive technology (ART); 10. Postoperative requests for IUD placement, hormonal contraceptives (oral/injectable), or subdermal implants; 11. Psychiatric or cognitive impairments affecting compliance with study procedures; 12. Any other condition deemed unsuitable for study participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative intrauterine adhesions;Incidence Rate of Adverse Events (AEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamic parameters of uterine spiral arteries;Endometrial thickness;Pregnancy outcomes at 1-year follow-up; | — |
Countries
China
Contacts
Public ContactYan Che
Shanghai Institute for Biomedical and Pharmaceutical Technologies
Outcome results
None listed