A Novel Tourniquet Technic for Massive PPH

Postpartum Hemorrhage Clinical Trial

— PPH  

Official title:

A Novel Atraumatic Tourniquet Technique in Cases of Excessive Bleeding During Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997397
• Other study ID #: IR-2016-01
• Status: Completed
• Phase: N/A
• First received: December 10, 2016
• Last updated: December 15, 2016
• Start date: December 2013
• Est. completion date: April 2016

Study information

• Verified date: December 2016
• Source: Irenbe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

In this study, the investigators aimed to find out the effect of a novel tourniquet technique, in cases of excessive bleeding during cesarean delivery.

Description:

In this retrospective comparative study, the investigators compared the peripartum features of patients who experienced profuse postpartum bleeding during C/S and this novel atraumatic tourniquet technique was used and not used.

In this technique; the uterus is exteriorized following the delivery of the baby and before the removal of the placenta to be able to apply the tourniquet technique. In this technique it is not obligatory to push the bladder before the procedure. Afterwards, the surgeon and the assistant palpate the ureters with both hands in the two sheaths of broad ligament and try to hear a 'click' sound which comes from ureter sliding out between both fingers. After confirming that the ureters are not in the surgical site, an atraumatic vascular DeBakey clamp is applied widely including both the infundibulopelvic ligament and uterine arteries. Thus, two-sided blood supply of the uterus is reduced significantly and this gives the surgeon some time, for planning further surgical procedures and also serves a minimal bloody surgical site. If the avascular state of the surgical site is needed for a prolonged time, for instance while preparing for a blood transfusion or while waiting until an experienced surgeon is available, the clamps were opened and closed intermittently for a maximum of 10 minutes, as to sustain the blood supply of the ovaries and the uterus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• The women who experienced profuse postpartum haemorrhage during cesarean section

Exclusion Criteria:

• none defined

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• tourniquet(+)
A novel atraumatic tourniquet technique, applied via placing a vascular clamp widely on both the infundibulopelvic ligament and uterine arteries.
• tourniquet(-)

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Irenbe

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

AbdRabbo SA. Stepwise uterine devascularization: a novel technique for management of uncontrolled postpartum hemorrhage with preservation of the uterus. Am J Obstet Gynecol. 1994 Sep;171(3):694-700. — View Citation

B-Lynch C, Coker A, Lawal AH, Abu J, Cowen MJ. The B-Lynch surgical technique for the control of massive postpartum haemorrhage: an alternative to hysterectomy? Five cases reported. Br J Obstet Gynaecol. 1997 Mar;104(3):372-5. — View Citation

Hayman RG, Arulkumaran S, Steer PJ. Uterine compression sutures: surgical management of postpartum hemorrhage. Obstet Gynecol. 2002 Mar;99(3):502-6. — View Citation

Ikeda T, Sameshima H, Kawaguchi H, Yamauchi N, Ikenoue T. Tourniquet technique prevents profuse blood loss in placenta accreta cesarean section. J Obstet Gynaecol Res. 2005 Feb;31(1):27-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin values	The differences in hemoglobin values just before the surgery and immediately after the surgery	1 hour	Yes
Primary	red blood cell transfusion	the amount of packed red blood cells, required for haemodynamic stability in the first 24 hour.	24 hours	Yes
Primary	fresh frozen plasma transfusion	the amount of packed fresh frozen plasma, required for haemodynamic stability in the first 24 hour.	24 hours	Yes