NCT02997397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

December 10, 2016

Last Update Submit

December 15, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

tourniquet (+)

The cases in which the tourniquet technique is used

Procedure: tourniquet(+)

tourniquet(-)

The cases in which the tourniquet technique is not used

Procedure: tourniquet(-)

Interventions

tourniquet(-)PROCEDURE
Also known as: The tourniquet was not used
tourniquet(-)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • The women who experienced profuse postpartum haemorrhage during cesarean section

You may not qualify if:

  • none defined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, İzmir, 35040, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Barış Büke, resident

    İRENBE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 10, 2016

First Posted

December 20, 2016

Study Start

December 1, 2013

Primary Completion

February 1, 2015

Study Completion

April 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

If needed

Locations