Delayed fetal cord clamping in preterm labour, Risk and benefits

• Register: ANZCTR
• Last refreshed on: 26 August 2019
• Main ID: ACTRN12618000758202
• Date of registration: 07/05/2018
• Prospective Registration: Yes
• Primary sponsor: Alzhraa university hospital
• 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,
• Date of first enrolment: 01/10/2018
• Target sample size: 210
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12618000758202.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Dr Nahed Ezzat Allam

• Name: Dr Nahed Ezzat Allam

Key inclusion & exclusion criteria

Inclusion criteria: women who delivered prematurely at 30 - 34 weeks gestation, singleton, delivered either normal vaginal or cesarean section.
Exclusion criteria: Maternal medical disorder ( diabetes , hypertension )
Fetal congenital anomalies
Meconium stained amniotic fluid
Placenta previa , abruption

Age minimum: 19 Years
Age maximum: 40 Years
Gender: Females

Health Condition(s) or Problem(s) studied

fetal anaemia ;fetal jaundice;
fetal anaemia
fetal jaundice

Blood - Anaemia

Reproductive Health and Childbirth - Childbirth and postnatal care

Intervention(s)

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.

Primary Outcome(s)

neonatal death assessed by the neonatologist as absent fetal cardiac pulsations by stethoscope and dilated pupil. [4 weeks post delivery]

fetal bilirubin level assessed by fetal blood sample taken by the neonatologist and will be sent to the laboratory

[3 days post delivery]

Fetal haemoglobin assessed by fetal blood sample taken by the neonatologist and will be sent to the laboratory
[one weeks after labour]

Secondary Outcome(s)

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.
[2-hour post delivery]

Maternal haemoglobin assessed by maternal blood sample taken by the nurse and sent to the laboratory
[one day post delivery]

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.
[first hour after labour]

Admission to neonatal intensive care unit (why, how many days ) assessed by the neonatologist.[up to one month post delivery]

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
[5 minutes post delivery]

Fetal weight assessed by nurse attending labour in kg using the digital scale.
[5 minutes post delivery]

Secondary ID(s)

none

Source(s) of Monetary Support

Azharaa university hospital

Ethics review

Status: Not approved
Approval date:
Contact:

Alazhar ethics committe