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Completed

NCT Number: NCT00579839

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature PreTerm Neonate Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Delayed Cord Clamping

Procedure

Delayed Cord Clamping: 30-35 seconds after birth

Immediate Cord Clamping

Procedure

Immediate Cord Clamping: within 5 seconds of birth

Primary outcomes

  1. 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.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

A Randomized Controlled Trial of Immediate Versus Delayed Cord Clamping in the Preterm Neonate

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Dec 24, 2007
Registry last updated
Jan 20, 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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