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

Blunt Expansion of the Uterine Incision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892215
• Other study ID #: MHST2012-08
• Status: Completed
• Phase: N/A
• First received: June 30, 2013
• Last updated: June 20, 2017
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2017
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blunt Expansion of the Uterine Incision

Intervention

Procedure:
• Cephalad-caudad expansion
Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.
• Transversal expansion
Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss (hemoglobin level)	Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.	72 hours
Secondary	Surgical complications	Number of cases of surgical complications (hematomas, unintended extension of the uterine incision, need for transfusion) between the two techniques.	72 hours
Secondary	Unintented extension of uterine incision	Number of cases of unintended extension of the uterine incision during surgery between the two techniques.	72 hours
Secondary	Hematoma formation	Number of cases of hematoma formation during or after between the two techniques.	72 hours
Secondary	Need for transfusion	Number of cases that required a blood transfusion between the two techniques.	72 hours