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

NCT ID: NCT03707132

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2017-09-30

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

Conditions

Placenta Accreta; Post Partum Hemorrhage; Blood Loss Massive

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Tourniquet Group

'Tourniquet: Folley catheter in the low segment of the uterus

Tourniquet: Folley catheter in the low segment of the uterus

Intervention Type: PROCEDURE

Control Group

Standard hysterectomy is performed

No interventions assigned to this group

Interventions

Tourniquet: Folley catheter in the low segment of the uterus

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No signs of accretetization upon artificial delivery

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Ben marzouk Sofiene

clinical associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hayen Maghrebi, Professor

Role: STUDY_CHAIR

Tunis Maternity Center

Other Identifiers

Garrot-Accreta

Identifier Type: -

Identifier Source: org_study_id