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

Stanger Hospital102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

102

Conditions

Low Birth Weight Perinatology Iron Status Cord Clamping

Interventions

Cord clampingPROCEDURE

Early vs Delayed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanger Hospital

KwaDukuza, KwaZulu-Natal, South Africa

Outcomes

Primary Outcomes

Haemoglobin level

Time frame: two months

Secondary Outcomes

Hyperviscosity syndrome

Time frame: 1 day

Iron status

Time frame: two months

hyperbilirubinaemia

Time frame: 2 days

Data from ClinicalTrials.gov

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