Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate

University of Oklahoma (OU)

Status: Completed

Conditions: PreTerm Birth; PreTerm Neonate

Treatments: Procedure: Delayed Cord Clamping; Procedure: Immediate Cord Clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT00579839

CordClampingElimian

Details and patient eligibility

About

To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.

Full description

This study is intended to be a randomized controlled trial comparing immediate cord clamping which represents the current standard of care at Oklahoma University Medical Center with delayed cord clamping among preterm neonates born between 24 weeks and 34 weeks 0 days weeks' gestation. Allocation sequence will be generated by simple randomization using random number table in the stratum 24-28 weeks 6 days and 29 weeks to 34 weeks 0 days weeks' gestation stratum.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton pregnancies
• Signed consent to participate in the trial

Exclusion criteria

• Major fetal anomaly or known fetal chromosomal abnormalities
• Multiple gestation
• Mothers with pregestational and gestational diabetes
• Refusal to participate in the trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A

Experimental group

Description:

Delayed Cord Clamping

Treatment:

Procedure: Delayed Cord Clamping

B

Active Comparator group

Description:

Immediate cord clamping

Treatment:

Procedure: Immediate Cord Clamping