A Novel Tourniquet Technic for Massive PPH (PPH)

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

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

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Procedure: tourniquet(+); Procedure: tourniquet(-)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35040
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Two groups of women who experienced profuse bleeding during C/S; one group in which a novel tourniquet technique was used and another group in which the tourniquet technique was not used.

Description

Inclusion Criteria:

• The women who experienced profuse postpartum haemorrhage during cesarean section

Exclusion Criteria:

• none defined

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
tourniquet (+); The cases in which the tourniquet technique is used	Procedure: tourniquet(+); A novel atraumatic tourniquet technique, applied via placing a vascular clamp widely on both the infundibulopelvic ligament and uterine arteries.
tourniquet(-); The cases in which the tourniquet technique is not used	Procedure: tourniquet(-); Other Names: The tourniquet was not used

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Irenbe
• Investigators: Principal Investigator: Barış Büke, resident, İRENBE

Publications and helpful links

General Publications

• 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. doi: 10.1111/j.1471-0528.1997.tb11471.x.
• Hayman RG, Arulkumaran S, Steer PJ. Uterine compression sutures: surgical management of postpartum hemorrhage. Obstet Gynecol. 2002 Mar;99(3):502-6. doi: 10.1016/s0029-7844(01)01643-x.
• 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. doi: 10.1016/0002-9378(94)90084-1.
• 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. doi: 10.1111/j.1447-0756.2005.00247.x.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: December 10, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (ESTIMATE): December 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 15, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: IR-2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If needed