Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1076 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Disruption of Uterine Incision After Cesarean Section

Keywords

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unintended extension blunt sharp maternal blood loss

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

sharp

Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Osman Aşıcıoğlu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İstanbul Bakırköy Maternal and Childrens Hospital

Istanbul, Bakırköy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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. doi: 10.1111/j.1471-0528.2002.01296.x.

Reference Type RESULT

PMID: 12013167 (View on PubMed)

Other Identifiers

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Aşıcıoğlu-01

Identifier Type: -

Identifier Source: org_study_id