Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital

ClinicalTrials.gov Identifier:

NCT01519440

First received: January 24, 2012

Last updated: October 21, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 24, 2012
Last Updated Date	October 21, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2012)	unintended extension of uterine incision [ Time Frame: during the operation ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01519440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2012)	intraoperative maternal blood loss [ Time Frame: after 48 hours than operation ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean
Official Title ^ICMJE	Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Crossover Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	elective cesarean delivery cases
Condition ^ICMJE	Disruption of Uterine Incision After Cesarean Section
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	blunt Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad. sharp Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors
Publications *	Magann EF, Chauhan SP, Bufkin L, Field K, Roberts WE, Martin JN Jr. Intra-operative haemorrhage by blunt versus sharp expansion of the uterine incision at caesarean delivery: a randomised clinical trial. BJOG. 2002 Apr;109(4):448-52.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1076
Completion Date	February 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Term pregnancy(> 38 weeks of gestation) Required elective cesarean delivery maternal age between 18-40 years Exclusion Criteria: Required emergency cesarean delivery Abnormal presentation Planned cesarean hysterectomy History of low segment vertical uterine incision History of classical upper segment uterine incision multiple pregnancy cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies) Grand multiparity(parity>5)
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Turkey

Administrative Information
NCT Number ^ICMJE	NCT01519440
Other Study ID Numbers ^ICMJE	Aşıcıoğlu-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
Study Sponsor ^ICMJE	Istanbul Bakirkoy Maternity and Children Diseases Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Istanbul Bakirkoy Maternity and Children Diseases Hospital
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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