Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

Not Applicable

Terminated

• Conditions: Premature Birth

• Registration Number: NCT01393834
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Study Start: 2011-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation
• Women ages 18 and older

Exclusion Criteria

• Planned vaginal breech delivery
• Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
• Fetal death in utero
• Red cell isoimmunization
• Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
• Placenta previa or other known abnormal placentation (e.g. placenta accreta)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse Neonatal Event	up to 24 weeks after birth	composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home

Secondary Outcome Measures

Name	Time	Method
Maternal estimated blood loss	up to 1 hour after delivery	Estimated blood loss at delivery
Any grade intraventricular hemorrhage	up to 24 weeks after birth
Severe intraventricular hemorrhage (grade 3 or 4)	up to 24 weeks after birth
Periventricular leukomalacia	up to 24 weeks after birth
Bronchopulmonary dysplasia	up to 24 weeks after birth
Peak transcutaneous and/or serum bilirubin concentrations	up to 24 weeks after birth
Phototherapy	up to 24 weeks after birth	Requirement and length of phototherapy
Ionotropic support	up to 24 weeks after birth	Requirement and length of ionotropic support
Neonatal intesive care unit (NICU) length of stay	up to 24 weeks after birth
Sepsis	up to 24 weeks after birth
Necrotizing enterocolitis	up to 24 weeks after birth
Respiratory distress syndrome	up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit	up to 24 weeks after birth
Ventilator time	up to 24 weeks after birth
Apgar score <7 at 5 minutes	at 5 minutes after birth
Umbilical cord pH < 7.0	up to 30 minutes after birth
Blood pressure on admission to neonatal intensive care unit	at 30 minutes after birth
Polycythemia	up to 24 hours of life
Hematocrit on admission to neonatal intensive care unit	up to 4 hours after birth
Neonatal death	up to 24 weeks of life
Length of 3rd stage of labor	up to 1 hour after birth	Time period between delivery of the baby and delivery of the placenta
Use of uterotonic agents	up to 1 hour after birth
Maternal blood transfusion	up to 5 days after delivery
Manual removal of placenta	up to 1 hour after birth
Operating time for cesarean delivery	up to 3 hours after birth