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

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

Study Overview

• Status: Completed
• Conditions: Placenta Accreta; Post Partum Hemorrhage; Blood Loss Massive
• Intervention / Treatment: Procedure: Tourniquet: Folley catheter in the low segment of the uterus

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

• Study Type: Observational
• Enrollment (Actual): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No signs of accretetization upon artificial delivery

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tourniquet Group; 'Tourniquet: Folley catheter in the low segment of the uterus	Procedure: Tourniquet: Folley catheter in the low segment of the uterus
Control Group; Standard hysterectomy is performed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: hysterectomy; Tourniquet; placenta accreta; low uterus segment; massive blood loss management
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Placenta Accreta
• Other Study ID Numbers: Garrot-Accreta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No