Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Primary Endpoint
- Estimated blood loss
Study Overview
Brief Summary
Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta
Detailed Description
It is a monocentric prospective observational case-control study in the Department "C" of Gynecology and Obstetrics in the Maternity and Neonatology Center of Tunis during three years from October 2014 to September 2017.
All parturient were informed about the possibility of performing a hysterectomy if accretization was clinically confirmed preoperatively. After obtaining written formal consent. all patients who underwent scheduled or emergency cesarean section for placenta accreta were included. Either it was highly suspected or confirmed by obstetrical imaging. MRI was always performed in cases of scheduled cesarean delivery. However, in cases of delayed transfer or if parturient was already in labor, only ultrasonography was done and considered as sufficient. Delivery was usually scheduled at 36 weeks of gestation.
Patients were allocated into two group: Group TG in which a tourniquet was systematically applied on the lower segment of the uterus during emergent hysterectomy, control group CG when the emergent caesarian hysterectomy was performed without a tourniquet. Allocation depended on the technique and the decision of the surgeon in charge.
After appropriate conditioning and monitoring, the cesarean section was performed under general anesthesia. The laparotomy was performed through a mid-line incision from the umbilicus to the pubic symphysis. Hysterotomy was made far from the placental insertion which was previously located by ultrasonography. The accretization was clinically checked immediately after delivery but no attempt was made to manually remove the placenta. The umbilical cord was ligated to its insertion and the uterus was quickly sutured with the placenta kept in place. Careful detachment of the bladder-uterus peritoneum was then carried out in order to lower the bladder and reduce the risk of bladder wounds. Tourniquet application procedure is described as following
- Suturing hysterotomy with placenta kept in place.
- After a cautious dissection a Folley catheter is placed in the lower segment of the uterus as tourniquet.
- complete hysterectomy
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •. All patients undergoing scheduled or emergency cesarean section for placenta accreta
Exclusion Criteria
- •No signs of accretetization upon artificial delivery
Outcomes
Primary Outcomes
Estimated blood loss
Time Frame: peroperatively
Blood spoliation during procedure
Hemoglobin variation
Time Frame: First 24 hours
the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure
Transfusion requirements
Time Frame: First 24 hours
Number of red blood cells units transfused
procedure duration
Time Frame: peroperatively
Time needed to perform hysterectomy from incision to skin closure
Intensive care transfer rate
Time Frame: first 24 hours
Intensive care transfer following hysterectomy for placenta accreta
Secondary Outcomes
- length of stay in ICU(time from surgery up to 30 days postoperative)
- clotting disorders(time from surgery up to 30 days postoperative)
- Bladder wound(time from surgery up to 30 days postoperative)
- Digestive wound(time from surgery up to 30 days postoperative)
Investigators
Ben marzouk Sofiene
clinical associate professor
University Tunis El Manar