cesarean scar defect
Conditions
Interventions
Experimental group:Surgical biological patch implanted and double suture
Control group:Conventional double suture
Sponsors
Women's Hospital School of Medicine Zhejiang University
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Puerpera aged 18 to 40 years. 2. The indications of operation for the first cesarean section was assessed to determine by the investigator based on the medical history, physical examination, laboratory tests, electrocardiogram, B-ultrasound, and maternal willingness. 3. Effective contraceptive measures should be taken 6 months after operation. 4. Able to understand the purpose of the trial, willing to cooperate with surgical treatment and follow-up, voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Cesarean section for three or more multiple births. 2. Preoperative premature rupture of membranes, uterine infection, genital tract inflammation and other infectious diseases. 3. Severe obstetric complications and complications (such as pulmonary hypertension, placenta accreta, preeclampsia, etc.). 4. Previous myomectomy penetrating the uterine cavity. 5. Severe autoimmune diseases (such as type 1 diabetes mellitus, rheumatoid arthritis, systemic lupus erythematosus, etc.). 6. Allergic history to porcine fibrinogen and polylactide caprolactone (PL-Cl). 7. MRI examination could not be performed due to claustrophobia or other reasons. 8. Participants in any interventional clinical trial within the past 60 days. 9. Other factors deemed unsuitable for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of preventing cesarean scar defect after 24 weeks after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of preventing cesarean scar defect after 12 weeks after operation;Incidence of symptomatic cesarean scar defect at 12 and 24 weeks after operation;Incidence of severe cesarean scar defect at 12 and 24 weeks after operation;Incidence of postoperative cesarean scar infection; | — |
Countries
China
Contacts
Public ContactWang Zhengping
Outcome results
None listed