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

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

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.

Study Overview

• Status: Completed
• Conditions: Blunt Expansion of the Uterine Incision
• Intervention / Treatment: Procedure: Cephalad-caudad expansion; Procedure: Transversal expansion

• Study Type: Interventional
• Enrollment (Actual): 839
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Panama
  • Panama, Panama
    • Saint Thomas Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama
• Investigators: Principal Investigator: Osvaldo Reyes, MD, Saint Thomas Maternity Hospital; Principal Investigator: Alberto Morales, MD, Saint Thomas Maternity Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 30, 2013
• First Submitted That Met QC Criteria: June 30, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Uterine incision.; Blunt transversal expansion.; Blunt cephalad-caudad expansion.
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: MHST2012-08