Clinical trial NCT02997397: A Novel Tourniquet Technic for Massive PPH
Official title: A Novel Atraumatic Tourniquet Technique in Cases of Excessive Bleeding During Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Lead sponsor: Irenbe
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* The women who experienced profuse postpartum haemorrhage during cesarean section

Exclusion Criteria:

* none defined

Primary outcomes:
measure: Hemoglobin values
timeFrame: 1 hour
measure: red blood cell transfusion
timeFrame: 24 hours
measure: fresh frozen plasma transfusion
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: İRENBE
name: Barış Büke, resident
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1471-0528.1997.tb11471.x.
citation: 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.
citation: 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.
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. doi: 10.1111/j.1447-0756.2005.00247.x.