Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

Completed

• Conditions: Disruption of Uterine Incision After Cesarean Section

• Registration Number: NCT01519440
• Lead Sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital

Brief Summary

The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-27
• Study Completion: 2012-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-21
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1076

Inclusion Criteria

1. Term pregnancy(> 38 weeks of gestation)
2. Required elective cesarean delivery
3. maternal age between 18-40 years

Exclusion Criteria

1. Required emergency cesarean delivery
2. Abnormal presentation
3. Planned cesarean hysterectomy
4. History of low segment vertical uterine incision
5. History of classical upper segment uterine incision
6. multiple pregnancy
7. cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies)
8. Grand multiparity(parity>5)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
unintended extension of uterine incision	during the operation

Secondary Outcome Measures

Name	Time	Method
intraoperative maternal blood loss	after 48 hours than operation

Trial Locations

Locations (1)

İstanbul Bakırköy Maternal and Childrens Hospital; 🇹🇷 İstanbul, Bakırköy, Turkey