Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants

Stanger Hospital

Status: Completed

Conditions: Iron Status; Perinatology; Cord Clamping; Low Birth Weight

Treatments: Procedure: Cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT01487980

DCC-LBW-SA

Details and patient eligibility

About

Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment.

Exclusion criteria

1. twin pregnancy
2. history of postpartum haemorrhage (PPH)
3. (gestational) diabetes
4. pre-eclampsia
5. abruptio placentae
6. caesarian section
7. necessity of early clamping due to tight nuchal cord
8. need for resuscitation immediately after birth
9. major congenital abnormalities

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Early cord clamping

Active Comparator group

Description:

Within 30 seconds after birth.

Treatment:

Procedure: Cord clamping

Delayed cord clamping

Experimental group

Description:

Between 2 and 3 minutes after birth

Treatment:

Procedure: Cord clamping