A Novel Tourniquet Technic for Massive PPH

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Procedure: tourniquet(+); Procedure: tourniquet(-)

• Registration Number: NCT02997397
• Lead Sponsor: Irenbe

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-02
• Study Completion: 2016-04
• Status Verified: 2016-12
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-15
• Last Update Submitted: 2016-12-15
• Study First Posted: 2016-12-20
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• The women who experienced profuse postpartum haemorrhage during cesarean section

Exclusion Criteria

• none defined

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tourniquet (+)	tourniquet(+)	The cases in which the tourniquet technique is used
tourniquet(-)	tourniquet(-)	The cases in which the tourniquet technique is not used

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Turkey