Clinical Trials Directory

Trials / Completed

CompletedNCT03707132

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
University Tunis El Manar · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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 1. Suturing hysterotomy with placenta kept in place. 2. After a cautious dissection a Folley catheter is placed in the lower segment of the uterus as tourniquet. 3. complete hysterectomy

Conditions

Interventions

TypeNameDescription
PROCEDURETourniquet: Folley catheter in the low segment of the uterus

Timeline

Start date
2014-10-01
Primary completion
2017-09-30
Completion
2017-09-30
First posted
2018-10-16
Last updated
2018-10-16

Source: ClinicalTrials.gov record NCT03707132. Inclusion in this directory is not an endorsement.