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

Primary Purpose

Blunt Expansion of the Uterine Incision

Status

Completed

Phase

Not Applicable

Locations

Panama

Study Type

Interventional

Intervention

Cephalad-caudad expansion

Transversal expansion

About this trial

This is an interventional treatment trial for Blunt Expansion of the Uterine Incision focused on measuring Uterine incision., Blunt transversal expansion., Blunt cephalad-caudad expansion.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Saint Thomas Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cephalad-caudad

Transversal expansion

Arm Description

Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.

Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.

Outcomes

Primary Outcome Measures

Blood loss (hemoglobin level)

Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.

Secondary Outcome Measures

Surgical complications

Number of cases of surgical complications (hematomas, unintended extension of the uterine incision, need for transfusion) between the two techniques.

Unintented extension of uterine incision

Number of cases of unintended extension of the uterine incision during surgery between the two techniques.

Hematoma formation

Number of cases of hematoma formation during or after between the two techniques.

Need for transfusion

Number of cases that required a blood transfusion between the two techniques.

Full Information

NCT ID

NCT01892215

First Posted

June 30, 2013

Last Updated

June 20, 2017

Sponsor

Saint Thomas Hospital, Panama

1. Study Identification

Unique Protocol Identification Number

NCT01892215

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saint Thomas Hospital, Panama

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blunt Expansion of the Uterine Incision

Keywords

Uterine incision., Blunt transversal expansion., Blunt cephalad-caudad expansion.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

839 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cephalad-caudad

Arm Type

Experimental

Arm Description

Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.

Arm Title

Transversal expansion

Arm Type

Experimental

Arm Description

Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.

Intervention Type

Procedure

Intervention Name(s)

Cephalad-caudad expansion

Intervention Description

Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.

Intervention Type

Procedure

Intervention Name(s)

Transversal expansion

Intervention Description

Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.

Primary Outcome Measure Information:

Title

Blood loss (hemoglobin level)

Description

Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Surgical complications

Description

Number of cases of surgical complications (hematomas, unintended extension of the uterine incision, need for transfusion) between the two techniques.

Time Frame

72 hours

Title

Unintented extension of uterine incision

Description

Number of cases of unintended extension of the uterine incision during surgery between the two techniques.

Time Frame

72 hours

Title

Hematoma formation

Description

Number of cases of hematoma formation during or after between the two techniques.

Time Frame

72 hours

Title

Need for transfusion

Description

Number of cases that required a blood transfusion between the two techniques.

Time Frame

72 hours

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osvaldo Reyes, MD

Organizational Affiliation

Saint Thomas Maternity Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alberto Morales, MD

Organizational Affiliation

Saint Thomas Maternity Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Thomas Maternity Hospital

City

Panama

Country

Panama

12. IPD Sharing Statement

Learn more about this trial

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

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