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Efficacy of Porcine Fibrin Sealant in Preventing Uterine Scar Defect after Cesarean Section: A Randomized Controlled Trial

Efficacy of Porcine Fibrin Sealant in Preventing Uterine Scar Defect after Cesarean Section: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117085
Enrollment
Unknown
Registered
2026-01-20
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Scar Defect

Interventions

Experimental group:Use porcine fibrin sealant and perform double-layer suturing
Control group:Standard double-layer suturing

Sponsors

Shulan (Hangzhou) Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–40 years, gestational age >= 38 weeks; 2.Pregnant women with singleton pregnancies undergoing elective primary cesarean sections; 3.Sign the informed consent form, committing to complete at least 6 months of postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1.Multiple pregnancies, placenta previa, placenta accreta; 2.History of uterine surgery (e.g., myomectomy) or uterine malformations; 3.Premature rupture of membranes or genital tract infections (including vaginitis, cervicitis, chorioamnionitis); 4.Emergency cesarean section or severe intraoperative complications (e.g., complex suturing of uterine incision tears, massive hemorrhage requiring blood transfusion); 5.Allergy to porcine fibrin sealant components or a history of severe allergic diseases; 6.Prolonged preoperative use of anticoagulants, glucocorticoids, or immunosuppressants.

Design outcomes

Primary

MeasureTime frame
Residual myometrial thickness, RMT;

Secondary

MeasureTime frame
Incidence of Uterine Scar Diverticulum Formation;Diverticulum length (mm), Diverticulum depth (mm);Blood loss during cesarean section (ml);Incidence of Abnormal Vaginal Bleeding;Incidence of adverse reactions;Incidence of postpartum hemorrhage;Average operating time (min);Incidence of severe scar defects;

Countries

China

Contacts

Public ContactGAN KWANG HANN

Shulan (Hangzhou) Hospital

guanghan.yan@shulan.com+86 136 4581 3233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026