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

NCT ID: NCT01487980

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Low Birth Weight Perinatology Iron Status Cord Clamping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early cord clamping

Within 30 seconds after birth.

Group Type ACTIVE_COMPARATOR

Cord clamping

Intervention Type PROCEDURE

Early vs Delayed

Delayed cord clamping

Between 2 and 3 minutes after birth

Group Type EXPERIMENTAL

Cord clamping

Intervention Type PROCEDURE

Early vs Delayed

Interventions

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Cord clamping

Early vs Delayed

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Stanger Hospital

OTHER

Sponsor Role lead

Responsible Party

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S. Tiemersma

Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sybrich Tiemersma, MD

Role: PRINCIPAL_INVESTIGATOR

Stanger Hospital

Locations

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Stanger Hospital

KwaDukuza, KwaZulu-Natal, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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DCC-LBW-SA

Identifier Type: -

Identifier Source: org_study_id