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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
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,
Secondary ID [1] 294345 0
none
Universal Trial Number (UTN)
U1111-1210-9642
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fetal anaemia 307085 0
fetal jaundice 307591 0
Condition category
Condition code
Reproductive Health and Childbirth 306194 306194 0 0
Childbirth and postnatal care
Blood 306736 306736 0 0
Anaemia

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 300663 0
Prevention
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
Control group
Active

Outcomes
Primary outcome [1] 305655 0
neonatal death assessed by the neonatologist as absent fetal cardiac pulsations by stethoscope and dilated pupil.
Timepoint [1] 305655 0
4 weeks post delivery
Primary outcome [2] 305204 0
Fetal haemoglobin assessed by fetal blood sample taken by the neonatologist and will be sent to the laboratory
Timepoint [2] 305204 0
one weeks after labour
Primary outcome [3] 305652 0
fetal bilirubin level assessed by fetal blood sample taken by the neonatologist and will be sent to the laboratory
Timepoint [3] 305652 0
3 days post delivery
Secondary outcome [1] 344497 0
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.
Timepoint [1] 344497 0
2-hour post delivery
Secondary outcome [2] 346049 0
Maternal haemoglobin assessed by maternal blood sample taken by the nurse and sent to the laboratory
Timepoint [2] 346049 0
one day post delivery
Secondary outcome [3] 346053 0
Admission to neonatal intensive care unit (why, how many days ) assessed by the neonatologist.
Timepoint [3] 346053 0
up to one month post delivery
Secondary outcome [4] 346052 0
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.
Timepoint [4] 346052 0
first hour after labour
Secondary outcome [5] 346050 0
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
Timepoint [5] 346050 0
5 minutes post delivery
Secondary outcome [6] 346051 0
Fetal weight assessed by nurse attending labour in kg using the digital scale.
Timepoint [6] 346051 0
5 minutes post delivery

Eligibility
Key inclusion criteria
women who delivered prematurely at 30 - 34 weeks gestation, singleton, delivered either normal vaginal or cesarean section.
Minimum age
19 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Maternal medical disorder ( diabetes , hypertension )
Fetal congenital anomalies
Meconium stained amniotic fluid
Placenta previa , abruption

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using shuffling card
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
1/06/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment outside Australia
Country [1] 9684 0
Egypt
State/province [1] 9684 0
Cairo

Funding & Sponsors
Funding source category [1] 298988 0
Hospital
Name [1] 298988 0
Azharaa university hospital
Country [1] 298988 0
Egypt
Primary sponsor type
Hospital
Name
Alzhraa university hospital
Address
Alzhraa university hospital
Almostashfa Alyounany street,Alabassia,Cairo ,Egypt
Country
Egypt
Secondary sponsor category [1] 298227 0
None
Name [1] 298227 0
none
Address [1] 298227 0
none
Country [1] 298227 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299917 0
Alazhar ethics committe
Ethics committee address [1] 299917 0
Ethics committee country [1] 299917 0
Egypt
Date submitted for ethics approval [1] 299917 0
05/03/2018
Approval date [1] 299917 0
Ethics approval number [1] 299917 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81982 0
Dr Nahed Ezzat Allam
Address 81982 0
Alzharaa university hospital
Almostashfa al younany street ,Alabassia ,cairo,Egypt
Country 81982 0
Egypt
Phone 81982 0
+201121116136
Fax 81982 0
Email 81982 0
nahedallam16@gmail.com
Contact person for public queries
Name 81983 0
Nahed Ezzat Allam
Address 81983 0
Azharaa university hospital,
Almostashfa al younany street ,Alabassia ,cairo,Egypt.
Country 81983 0
Egypt
Phone 81983 0
+201121116136
Fax 81983 0
Email 81983 0
nahedallam16@gmail.com
Contact person for scientific queries
Name 81984 0
Nahed Ezzat Allam
Address 81984 0
Alzharaa university hospital ,
Almostashfa al younany street ,Alabassia ,cairo,Egypt..
Country 81984 0
Egypt
Phone 81984 0
+201121116136
Fax 81984 0
+201121116136
Email 81984 0
nahedallam16@gmail.com

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo 210 premature infants subjected randomly to eithe... [More Details]
Basic resultsNo

Documents added automatically
No additional documents have been identified.