Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,
1 other identifier
interventional
839
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 30, 2013
CompletedFirst Posted
Study publicly available on registry
July 4, 2013
CompletedJune 22, 2017
June 1, 2017
7 months
June 30, 2013
June 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood loss (hemoglobin level)
Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.
72 hours
Secondary Outcomes (4)
Surgical complications
72 hours
Unintented extension of uterine incision
72 hours
Hematoma formation
72 hours
Need for transfusion
72 hours
Study Arms (2)
Cephalad-caudad
EXPERIMENTALBlunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.
Transversal expansion
EXPERIMENTALBlunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Singleton pregnancies
- Gestational age: 34 weeks or more
- Delivery by cesarean section
- Presurgical hemoglobin \> 10.5 g/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Thomas Maternity Hospital
Panama City, Panama
Study Officials
- PRINCIPAL INVESTIGATOR
Osvaldo Reyes, MD
Saint Thomas Maternity Hospital
- PRINCIPAL INVESTIGATOR
Alberto Morales, MD
Saint Thomas Maternity Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinator of Research
Study Record Dates
First Submitted
June 30, 2013
First Posted
July 4, 2013
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
June 22, 2017
Record last verified: 2017-06