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

Not Applicable

Completed

• Conditions: Low Birth Weight; Perinatology; Iron Status; Cord Clamping
• Interventions: Procedure: Cord clamping

• Registration Number: NCT01487980
• Lead Sponsor: Stanger Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Study Start: 2012-01
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-15
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early cord clamping	Cord clamping	Within 30 seconds after birth.
Delayed cord clamping	Cord clamping	Between 2 and 3 minutes after birth

Primary Outcome Measures

Name	Time	Method
Haemoglobin level	two months

Secondary Outcome Measures

Name	Time	Method
Hyperviscosity syndrome	1 day
Iron status	two months
hyperbilirubinaemia	2 days

Trial Locations

Locations (1)

Stanger Hospital; 🇿🇦 Stanger, KwaZulu-Natal, South Africa