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Cesarean scar defects after full thickness myometrial closure versus split thickness myometrial closure in caesarean section: a multicentre, randomised controlled trial

Cesarean scar defects after full thickness myometrial closure versus split thickness myometrial closure in caesarean section: a multicentre, randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009476
Enrollment
Unknown
Registered
2016-10-18
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Cesarean scar defects

Interventions

Group 1:full thickness myometrial
Group 2:split thickness myometrial

Sponsors

International Peace Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women who meet all the following conditions will be recruited in our study: 1. The first elective delivery by lower segment caesarean section through a transverse abdominal incision; 2. Gestational week =36 weeks; 3. Aged 20 to 40 years; 4. Singleton fetus; 5. Platelet count>100×10^9/L; Hemoglobin concentration>90g/L; 6. If a patients with ovarian cyst, diameter of the mass is < 5cm; 7. No infectious diseases or mental disorders.

Exclusion criteria

Exclusion criteria: Women who meet any of the following conditions will be excluded from our study: 1. Prenatal and intrapartum fever. 2. if there is clear indication for a particular surgical technique or material to be used, that interferes with any of the allocated interventions, e.g. in a previous vertical incision. 3. Women who have previously been diagnosed with a uterine abnormality such as a malformed uterus (uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, hysteromyoma, or scarred uterus; 4. Women who have antepartum hemorrhage such as placenta previa and placental abruption; 5. Women who have malignancy or other severe systemic disease.

Design outcomes

Primary

MeasureTime frame
The rate of cesarean scar defect diagnosed by transvaginal B ultrasound within one year after the cesarean section;

Secondary

MeasureTime frame
(1) Intraoperative blood loss; (2) Postoperative hospital stay; (3) Postoperative complications; (4) Rate of rehospitalization within six weeks after the surgery; (5) Operative time (from the start to the end of closure of uterine incision) (6) The rate of chronic pelvic pain;

Countries

China

Contacts

Public ContactJian Zhang

Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University

zhangjian_ipmch@sjtu.edu.cn+86 21 64070434

Outcome results

None listed

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