Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta

Study Overview
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Brief Summary
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Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta

Detailed Description
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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

Official Title
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Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold

Conditions
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Placenta Accreta, Post Partum Hemorrhage, Blood Loss Massive

Intervention / Treatment
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* Procedure: Tourniquet: Folley catheter in the low segment of the uterus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . All patients undergoing scheduled or emergency cesarean section for placenta accreta Exclusion Criteria: No signs of accretetization upon artificial delivery
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tourniquet Group<br>'Tourniquet: Folley catheter in the low segment of the uterus | Procedure: Tourniquet: Folley catheter in the low segment of the uterus<br> <br> |
| Control Group<br>Standard hysterectomy is performed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated blood loss | Blood spoliation during procedure | peroperatively | 
| Hemoglobin variation | the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure | First 24 hours | 
| Transfusion requirements | Number of red blood cells units transfused | First 24 hours | 
| procedure duration | Time needed to perform hysterectomy from incision to skin closure | peroperatively | 
| Intensive care transfer rate | Intensive care transfer following hysterectomy for placenta accreta | first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in ICU | duration of the stay in the ICU following hysterectomy for placenta accreta | time from surgery up to 30 days postoperative | 
| clotting disorders | Assessed by the incidence of Intravascular disseminated coagulopathy | time from surgery up to 30 days postoperative | 
| Bladder wound | Incidence of accidental bladder damage | time from surgery up to 30 days postoperative | 
| Digestive wound | Incidence of accidental digestive lesion | time from surgery up to 30 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourniquet, low uterus segment, placenta accreta, hysterectomy, massive blood loss management