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Trial registered on ANZCTR
Registration number
ACTRN12618000758202p
Ethics application status
Submitted, not yet approved
Date submitted
15/03/2018
Date registered
7/05/2018
Date last updated
7/05/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Delayed fetal cord clamping in preterm labour, Risk and benefits
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Scientific title
Delayed fetal cord clamping in premature labour: the effect on fetal haemoglobin, bilirubin and neonatal death, maternal haemoglobin, neonatal ICU admission and postpartum haemorrhage,
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Secondary ID [1]
294345
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none
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Universal Trial Number (UTN)
U1111-1210-9642
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
fetal anaemia
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fetal jaundice
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Condition category
Condition code
Reproductive Health and Childbirth
306194
306194
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0
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Childbirth and postnatal care
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Blood
306736
306736
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0
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Anaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1 will be subjected after fetal body expulsion to immediate(first 5 seconds) cord clamping between two clamps without cord milking in neonates delivered prematurely at 30 to 34 weeks gestation. by obstetrician attending the labour, and recorded in the patient file.
duration of intervention <5 seconds.
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Intervention code [1]
300663
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Prevention
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Comparator / control treatment
Arm 2 will be subjected after fetal body delivery to delayed cord clamping (until cord pulsation stops spontaneously or 1 to 2 minutes)without cord milking in neonates delivered prematurely at 30 to 34 weeks gestation.by obstetrician attending the labour, and recorded in the patient file.
duration of intervention 1-2 minutes
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Control group
Active
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Outcomes
Primary outcome [1]
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Fetal haemoglobin assessed by fetal blood sample taken by the neonatologist and will be sent to the laboratory
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Assessment method [1]
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Timepoint [1]
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one weeks after labour
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Primary outcome [2]
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fetal bilirubin level assessed by fetal blood sample taken by the neonatologist and will be sent to the laboratory
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Assessment method [2]
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Timepoint [2]
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3 days post delivery
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Primary outcome [3]
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neonatal death assessed by the neonatologist as absent fetal cardiac pulsations by stethoscope and dilated pupil.
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Assessment method [3]
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Timepoint [3]
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4 weeks post delivery
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Secondary outcome [1]
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duration of the third stage of delivery assessed by obstetrician attending labour per minutes using a stopwatch.
the third stage of labour will be calculated and recorded in minutes as secondary outcomes to be compared between the studied groups.
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Assessment method [1]
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Timepoint [1]
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2-hour post delivery
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Secondary outcome [2]
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Maternal haemoglobin assessed by maternal blood sample taken by the nurse and sent to the laboratory
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Assessment method [2]
346049
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Timepoint [2]
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one day post delivery
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Secondary outcome [3]
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5 minutes Apgar score assessed after 5 minutes of delivery, by the neonatologist, including 5 items(breathing rate, heart rate, muscle tone, reflexes, skin colour) each category is scored with 0,1,2 depending on condition
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Assessment method [3]
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Timepoint [3]
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5 minutes post delivery
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Secondary outcome [4]
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Fetal weight assessed by nurse attending labour in kg using the digital scale.
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Assessment method [4]
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Timepoint [4]
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5 minutes post delivery
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Secondary outcome [5]
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Resuscitation data, type assessed by the neonatologist and recorded in the patient file.as: oxygen mask, Ambu-bag, suctioning, chest compression, heart massage, administration of epinephrine, endotracheal intubation.
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Assessment method [5]
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Timepoint [5]
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first hour after labour
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Secondary outcome [6]
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Admission to neonatal intensive care unit (why, how many days ) assessed by the neonatologist.
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Assessment method [6]
346053
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Timepoint [6]
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up to one month post delivery
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Eligibility
Key inclusion criteria
women who delivered prematurely at 30 - 34 weeks gestation, singleton, delivered either normal vaginal or cesarean section.
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Minimum age
19
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Maternal medical disorder ( diabetes , hypertension )
Fetal congenital anomalies
Meconium stained amniotic fluid
Placenta previa , abruption
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using shuffling card
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Analysis of data will be done using SPSS (statistical package for social science
version 20) as follows:
Description of quantitative variables as mean, SD ,range and mean difference
Description of qualitative variables as number and percentage.
Chi-square test will be used to compare qualitative variables between
groups.
Fisher exact test will be used instead of chi-square when one expected less
than or equal 5.
T-test will be used to compare quantitative variables, in parametric data
(SD<50% mean).
Correlation coefficient test will be used to rank different variables against
each other's positively or inversely.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2018
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Actual
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Date of last participant enrolment
Anticipated
1/06/2019
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
210
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Egypt
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State/province [1]
9684
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Cairo
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Azharaa university hospital
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Address [1]
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Almostshfa alyuonany street,abasia,cairo
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Country [1]
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Egypt
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Primary sponsor type
Hospital
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Name
Alzhraa university hospital
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Address
Alzhraa university hospital
Almostashfa Alyounany street,Alabassia,Cairo ,Egypt
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Country
Egypt
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
298227
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none
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Country [1]
298227
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
299917
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Alazhar ethics committe
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Ethics committee address [1]
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Alzhar university
Almokhyam Aldaaem street ,nasr city ,cairo,Egypt
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Ethics committee country [1]
299917
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Egypt
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Date submitted for ethics approval [1]
299917
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05/03/2018
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Approval date [1]
299917
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Ethics approval number [1]
299917
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Summary
Brief summary
Preterm birth is a major cause of death and a significant cause of long-term loss of human
potential all around the world. Complications of preterm birth are the
single largest direct cause of neonatal deaths and the second most common cause of under-5 deaths after pneumonia..All newborns are generally fragile and more so premature babies, making them in continuous need for special care . Advances in medical technology have contributed to smaller infants surviving past the neonatal period. This survival,however, is fraught by many complications including respiratory distress syndrome , neonatal indirect hyperbilirubinemia , sepsis, apnea and anemia of prematurity .Our study hypotheses that delayed clamping in preterm labor allows time for transfusion of placental blood to the newborn infant. This can provide the neonate with an additional blood volume,decrease need for blood transfusion as reported by American congress of obstetricians and gynecologists thereby protecting it from anemia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
81982
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Dr Nahed Ezzat Allam
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Address
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Alzharaa university hospital
Almostashfa al younany street ,Alabassia ,cairo,Egypt
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Country
81982
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Egypt
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Phone
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+201121116136
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
81983
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Dr Nahed Ezzat Allam
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Address
81983
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Azharaa university hospital,
Almostashfa al younany street ,Alabassia ,cairo,Egypt.
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Country
81983
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Egypt
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Phone
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+201121116136
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Fax
81983
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Email
81983
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[email protected]
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Contact person for scientific queries
Name
81984
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Dr Nahed Ezzat Allam
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Address
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Alzharaa university hospital ,
Almostashfa al younany street ,Alabassia ,cairo,Egypt..
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Country
81984
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Egypt
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Phone
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+201121116136
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Fax
81984
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+201121116136
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Email
81984
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4074
Plain language summary
No
210 premature infants subjected randomly to eithe...
[
More Details
]
4180
Basic results
No
Documents added automatically
No additional documents have been identified.
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