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

NCT ID: NCT01892215

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 839 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Blunt Expansion of the Uterine Incision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cephalad-caudad

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

Group Type: EXPERIMENTAL

Cephalad-caudad expansion

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Transversal expansion

Intervention Type: PROCEDURE

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

Interventions

Cephalad-caudad expansion

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

Intervention Type: PROCEDURE

Transversal expansion

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

Intervention Type: PROCEDURE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saint Thomas Hospital, Panama

OTHER

Sponsor Role: lead

Responsible Party

Osvaldo A. Reyes T.

Coordinator of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osvaldo Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Maternity Hospital

Alberto Morales, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Maternity Hospital

Locations

Saint Thomas Maternity Hospital

Panama City, , Panama

Countries

Panama

Other Identifiers

MHST2012-08

Identifier Type: -

Identifier Source: org_study_id