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A multicenter randomized controlled clinical trial of knot free technique and suture versus traditional suture in cesarean section

A multicenter randomized controlled clinical trial of knot free technique and suture versus traditional suture in cesarean section

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039282
Enrollment
Unknown
Registered
2020-10-22
Start date
2020-10-26
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Cesarean section

Interventions

Barbed suture group:Barbed sutur
Conventional suture group:Conventional suture

Sponsors

West China second hospital, Sichuan university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. The patients who received elective planned cesarean section at gestational age >= 37 weeks; 2. The subjects whose age is greater than or equal to 18 years old but less than 40 years old; 3. The subjects of cesarean delivery due to obstetric indications; 4. Pregnant women are willing to participate in the study, comply with the research requirements, follow-up arrangements, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with body mass index > 28KG / m2 before pregnancy or > 32kg / m2 after pregnancy; or patients with body mass index < 18.5kg/m2 before pregnancy; 2. Subjects with anterior low segment myoma or uterine myoma, and the maximum diameter of myoma is more than 5cm; 3. Patients with chorioamnionitis, GDM / DM with poor glycemic control, preeclampsia, placental abruption and thrombotic tendency; 4. The subjects who used drugs affecting coagulation function / platelet function before operation; 5. Subjects with known placenta previa or placenta accreta, or with uterine malformation; 6. The subject of scar uterus; 7. The patients with severe hepatic and renal insufficiency have platelet < 80 * 10^9 / L or abnormal coagulation function; 8. Subjects of multiple pregnancy; 9. Pregnant women with infection before operation and treated with oral or intravenous antibiotics; 10. Pregnant women who had received chemotherapy or radiotherapy within 6 months before the study, or arranged to receive chemotherapy or radiotherapy during the study period; 11. Pregnant women currently participating in any other clinical drug (within 30 days or within 5 half lives of the test drug) or device research; 12. Any pregnant women who may affect any physical or psychological condition of the participants in the study; 13. For any other reason, pregnant women who were judged by the researchers to be unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Time required to suture the uterine incision;

Secondary

MeasureTime frame
Total blood loss during suture of uterine incision;Additional stitches for hemostasis;Total blood loss in cesarean section;Incidence of uterine scar diverticulum (3 months after operation);Incidence of uterine scar diverticulum (6 months after operation);Length of hospital stay after surgery to discharge;Incidence of surgical incision complications;Preoperative hemoglobin;Postoperative hemoglobin;Postoperative body temperature;Vaginal bleeding three days after surgery;

Countries

China

Contacts

Public ContactLiu Xinghui

West China Second Hospital of Sichuan University

xinghuiliu@163.com+86 13881883798

Outcome results

None listed

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