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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707132
• Other study ID #: Garrot-Accreta
• Status: Completed
• Start date: October 1, 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2018
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No signs of accretetization upon artificial delivery

Related Conditions & MeSH terms

• Blood Loss Massive
• Hemorrhage
• Placenta Accreta
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• Tourniquet: Folley catheter in the low segment of the uterus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss	Blood spoliation during procedure	peroperatively
Primary	Hemoglobin variation	the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure	First 24 hours
Primary	Transfusion requirements	Number of red blood cells units transfused	First 24 hours
Primary	procedure duration	Time needed to perform hysterectomy from incision to skin closure	peroperatively
Primary	Intensive care transfer rate	Intensive care transfer following hysterectomy for placenta accreta	first 24 hours
Secondary	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
Secondary	clotting disorders	Assessed by the incidence of Intravascular disseminated coagulopathy	time from surgery up to 30 days postoperative
Secondary	Bladder wound	Incidence of accidental bladder damage	time from surgery up to 30 days postoperative
Secondary	Digestive wound	Incidence of accidental digestive lesion	time from surgery up to 30 days postoperative