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.
Verified date | June 2017 |
Source | Saint Thomas Hospital, Panama |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Panama | Saint Thomas Maternity Hospital | Panama |
Lead Sponsor | Collaborator |
---|---|
Saint Thomas Hospital, Panama |
Panama,
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 |