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SLCTR Registration Number
SLCTR/2013/003
Date of Registration
The date of last modification
Mar 06, 2014
View original TRDS
Scientific Title of Trial
Effects of early versus delayed umbilical cord clamping during ante-partum lower segment caesarean section on placental delivery and post operative blood loss : A Randomized Controlled Trial.
Public Title of Trial
Effects of early versus delayed umbilical cord clamping during ante-partum lower segment caesarean section on placental delivery and post operative blood loss : A Randomized Controlled Trial.
Disease or Health Condition(s) Studied
Caesarean delivery techniques
Scientific Acronym
None
Public Acronym
None
Brief title
Delayed cord clamping
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is delayed umbilical cord clamping during ante-partum lower segment caesarean section associated with increased time interval for placental delivery and increased post operative blood loss?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Prevention
Study Phase
Intervention(s) planned
Consenting women who fill the inclusion criteria will be randomized into 3 arms using computer generated random numbers. Caesarean sections will be carried out by the principle investigator and the same routine operative techniques will be used. The umbilical cord of the baby will be clamped as soon as possible and in <15 seconds (Group 1) or between 60 – 75 seconds (Group 2) or between 120 – 135 seconds (Group 3) The Anaesthetist will be blinded and he will carry out a separate visual estimation of blood loss using soaked gauze towels & contents of sucker bottle (blood & liquor with correction for liquor) The Principal Investigator not blinded and direct measurement, gravimetric method & calculation based on pre & post CS Hb will be carried out by him.
Inclusion criteria
• Women undergoing elective LSCS • POG between 37-42 weeks • Intact membranes • Healthy foetal parameters
Exclusion criteria
Rh negative mothers • High risk of PPH : multiple pregnancies, fetal macrosomia (estimated fetal weight >3.5 kg), polyhydramnios (AFI >25), severe hypertension in pregnancy (BP>160/110mmHg), placenta previa abruptio placentae • Pre-labour rupture of membranes • Failed inductions
Primary outcome(s)
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1.
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[
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2.
Mean blood loss in ml |
[ During LSCS ] |
|
3.
Maternal Hb & PCV |
[ At baseline and post-operatively after 48-60 hours ] |
Secondary outcome(s)
|
1.
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[
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|
2.
Neonatal complications: i. Neonatal jaundice requiring phototherapy ii. 5 minutes APGAR <7 iii. Respiratory Distress Syndrome. iv. Needing admission to Special Care Baby Unit |
[ From time of delivery up to 72 hours ] |
Target number/sample size
150 (50 per arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-01-21
Anticipated end date
2013-04-30
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Dr. M.R Withanathanthrige
Registrar in Obstetrics and Gynaecology
Teaching Hospital, Mahamodara, Sri Lanka
077 2246010
manojwithanathantrige@yahoo.com
Contact Person for Public Queries
Professor Malik Goonewardene
Senior Professor and Head
Department Department of Obstetrics and Gynaecology Faculty of Medicine, PO Box 70, Galle
091-2246878, 091-2234121
malikg@eureka.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
