Clinical trial NCT03707132: Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
Official title: Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Post Partum Hemorrhage
Blood Loss Massive
Keywords: Tourniquet
low uterus segment
placenta accreta
hysterectomy
massive blood loss management
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 43
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All parturients with suspected placenta accreta either on MRI if the C section is scheduled or on Ultrasound if an emmergent delivery is set

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

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

Eligibility criteria: Inclusion Criteria:

* . All patients undergoing scheduled or emergency cesarean section for placenta accreta

Exclusion Criteria:

* No signs of accretetization upon artificial delivery

Primary outcomes:
measure: Estimated blood loss
timeFrame: peroperatively
measure: Hemoglobin variation
timeFrame: First 24 hours
measure: Transfusion requirements
timeFrame: First 24 hours
measure: procedure duration
timeFrame: peroperatively
measure: Intensive care transfer rate
timeFrame: first 24 hours
Secondary outcomes:
measure: length of stay in ICU
timeFrame: time from surgery up to 30 days postoperative
measure: clotting disorders
timeFrame: time from surgery up to 30 days postoperative
measure: Bladder wound
timeFrame: time from surgery up to 30 days postoperative
measure: Digestive wound
timeFrame: time from surgery up to 30 days postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Tunis Maternity Center
name: Hayen Maghrebi, Professor
role: STUDY_CHAIR
References: