Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
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|ClinicalTrials.gov Identifier: NCT03707132|
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment|
|Placenta Accreta Post Partum Hemorrhage Blood Loss Massive||Procedure: Tourniquet: Folley catheter in the low segment of the uterus|
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 Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold|
|Actual Study Start Date :||October 1, 2014|
|Actual Primary Completion Date :||September 30, 2017|
|Actual Study Completion Date :||September 30, 2017|
'Tourniquet: Folley catheter in the low segment of the uterus
Procedure: Tourniquet: Folley catheter in the low segment of the uterus
Standard hysterectomy is performed
- 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
- length of stay in ICU [ Time Frame: time from surgery up to 30 days postoperative ]duration of the stay in the ICU following hysterectomy for placenta accreta
- clotting disorders [ Time Frame: time from surgery up to 30 days postoperative ]Assessed by the incidence of Intravascular disseminated coagulopathy
- Bladder wound [ Time Frame: time from surgery up to 30 days postoperative ]Incidence of accidental bladder damage
- Digestive wound [ Time Frame: time from surgery up to 30 days postoperative ]Incidence of accidental digestive lesion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707132
|Study Chair:||Hayen Maghrebi, Professor||Tunis Maternity Center|