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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
SLCTR/2013/003 |
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Date of registration:
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2013-01-20 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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. |
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Date of first enrolment:
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2013-01-21 |
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Target sample size:
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150 (50 per arm) |
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Recruitment status: |
Complete: follow up complete |
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URL:
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https://slctr.lk/trials/slctr-2013-003 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial
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Phase:
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Not Available
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Professor Malik Goonewardene
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Address:
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Department Department of Obstetrics and Gynaecology Faculty of Medicine, PO Box 70, Galle
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Telephone:
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091-2246878, 091-2234121 |
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Email:
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malikg@eureka.lk |
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Affiliation:
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Senior Professor and Head |
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Name:
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Dr. M.R Withanathanthrige
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Address:
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Teaching Hospital, Mahamodara, Sri Lanka
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Telephone:
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Email:
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manojwithanathantrige@yahoo.com |
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Affiliation:
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Registrar in Obstetrics and Gynaecology |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Caesarean delivery techniques
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Intervention(s)
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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.
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Primary Outcome(s)
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Time interval from delivery of the baby to the delivery of the placenta [During LSCS]
Mean blood loss in ml [During LSCS]
Maternal Hb & PCV [At baseline and post-operatively after 48-60 hours ]
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Secondary Outcome(s)
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Maternal complications:
i. Blood transfusion
ii. Manual removal of placentae
iii. Need of additional uterotonics [Intra and post operatively until discharge ]
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]
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Source(s) of Monetary Support
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None
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Ethics review
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Status: Approved
Approval date: 22/11/2012
Contact:
ethics@med.ruh.ac.lk
Ethics Review Committee, Faculty of Medicine, University of Ruhuna
+94-91-2234801/803 (Extension: 161)
ethics@med.ruh.ac.lk
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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