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Completed

NCT Number: NCT01487980

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

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.

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Key information

Conditions

Low Birth Weight Cord Clamping Iron Status Perinatology

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanger Hospital

KwaDukuza, KwaZulu-Natal, 4450, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • twin pregnancy
  • history of postpartum haemorrhage (PPH)
  • (gestational) diabetes
  • pre-eclampsia
  • abruptio placentae
  • caesarian section
  • necessity of early clamping due to tight nuchal cord
  • need for resuscitation immediately after birth
  • major congenital abnormalities

Treatment and study plan

Cord clamping

Procedure

Early vs Delayed

Primary outcomes

  1. Haemoglobin level

    Time frame: two months

Secondary outcomes

  1. Hyperviscosity syndrome

    Time frame: 1 day

  2. Iron status

    Time frame: two months

  3. hyperbilirubinaemia

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Stanger Hospital

Other

Collaborators

  • Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)

Registry information

Official study title

The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2011
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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