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Clinical Trials/NCT02997397
NCT02997397
Completed
Not Applicable

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

Irenbe1 site in 1 country37 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage
Sponsor
Irenbe
Enrollment
37
Locations
1
Primary Endpoint
red blood cell transfusion
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
April 2016
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Irenbe
Responsible Party
Principal Investigator
Principal Investigator

Baris Buke

M.D.

Irenbe

Eligibility Criteria

Inclusion Criteria

  • The women who experienced profuse postpartum haemorrhage during cesarean section

Exclusion Criteria

  • none defined

Outcomes

Primary Outcomes

red blood cell transfusion

Time Frame: 24 hours

the amount of packed red blood cells, required for haemodynamic stability in the first 24 hour.

Hemoglobin values

Time Frame: 1 hour

The differences in hemoglobin values just before the surgery and immediately after the surgery

fresh frozen plasma transfusion

Time Frame: 24 hours

the amount of packed fresh frozen plasma, required for haemodynamic stability in the first 24 hour.

Study Sites (1)

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