Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,

Study Overview
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Brief Summary
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Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of the increase in the rate of cesarean section, any procedure that could help reduce blood loss during cesarean section should be investigated. The purpose of this study was to compare 2 methods of blunt expansion of the uterine incision at the time of cesarean delivery: transversal vs. cephalad-caudad.

Official Title
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Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad. A Randomized, Controlled Trial.

Conditions
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Blunt Expansion of the Uterine Incision

Intervention / Treatment
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* Procedure: Cephalad-caudad expansion
* Procedure: Transversal expansion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancies Gestational age: 34 weeks or more Delivery by cesarean section Presurgical hemoglobin > 10.5 g/dL Exclusion Criteria: Two or more previous cesarean sections History of uterine rupture in a previous pregnancy History of myomectomy History of abdominal trauma with an uterine lesion Blood dyscrasia Multiple pregnancy Placenta previa Abruptio placenta Stillbirth Sharp uterine expansion
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cephalad-caudad<br>Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction. | Procedure: Cephalad-caudad expansion<br>* Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.<br>|
| Experimental: Transversal expansion<br>Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction. | Procedure: Transversal expansion<br>* Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss (hemoglobin level) | Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Number of cases of surgical complications (hematomas, unintended extension of the uterine incision, need for transfusion) between the two techniques. | 72 hours | 
| Unintented extension of uterine incision | Number of cases of unintended extension of the uterine incision during surgery between the two techniques. | 72 hours | 
| Hematoma formation | Number of cases of hematoma formation during or after between the two techniques. | 72 hours | 
| Need for transfusion | Number of cases that required a blood transfusion between the two techniques. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine incision., Blunt transversal expansion., Blunt cephalad-caudad expansion.