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Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

This study has been terminated.
(difficulty with enrollment)
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01393834
First received: June 1, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes

June 1, 2011
February 20, 2013
December 2011
January 2013   (final data collection date for primary outcome measure)
Adverse Neonatal Event [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
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
Adverse Neonatal Event [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
composite of bronchopulmonary dysplasia (BPD), NEC, grade 3 or 4 IVH or periventricular leukomalacia (PVL), or death prior to discharge home
Complete list of historical versions of study NCT01393834 on ClinicalTrials.gov Archive Site
  • Maternal estimated blood loss [ Time Frame: up to 1 hour after delivery ] [ Designated as safety issue: Yes ]
    Estimated blood loss at delivery
  • Any grade intraventricular hemorrhage [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Severe intraventricular hemorrhage (grade 3 or 4) [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Periventricular leukomalacia [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Bronchopulmonary dysplasia [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Peak transcutaneous and/or serum bilirubin concentrations [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: Yes ]
  • Phototherapy [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: Yes ]
    Requirement and length of phototherapy
  • Ionotropic support [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
    Requirement and length of ionotropic support
  • Neonatal intesive care unit (NICU) length of stay [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Sepsis [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Necrotizing enterocolitis [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Respiratory distress syndrome [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Number of blood transfusions while in the neonatal intensive care unit [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Ventilator time [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Apgar score <7 at 5 minutes [ Time Frame: at 5 minutes after birth ] [ Designated as safety issue: Yes ]
  • Umbilical cord pH < 7.0 [ Time Frame: up to 30 minutes after birth ] [ Designated as safety issue: Yes ]
  • Blood pressure on admission to neonatal intensive care unit [ Time Frame: at 30 minutes after birth ] [ Designated as safety issue: No ]
  • Polycythemia [ Time Frame: up to 24 hours of life ] [ Designated as safety issue: Yes ]
  • Hematocrit on admission to neonatal intensive care unit [ Time Frame: up to 4 hours after birth ] [ Designated as safety issue: No ]
  • Neonatal death [ Time Frame: up to 24 weeks of life ] [ Designated as safety issue: No ]
  • Length of 3rd stage of labor [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
    Time period between delivery of the baby and delivery of the placenta
  • Use of uterotonic agents [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
  • Maternal blood transfusion [ Time Frame: up to 5 days after delivery ] [ Designated as safety issue: Yes ]
  • Manual removal of placenta [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
  • Operating time for cesarean delivery [ Time Frame: up to 3 hours after birth ] [ Designated as safety issue: Yes ]
  • Maternal estimated blood loss [ Time Frame: up to 1 hour after delivery ] [ Designated as safety issue: Yes ]
    Estimated blood loss at delivery
  • Any grade intraventricular hemorrhage [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Severe intraventricular hemorrhage (grade 3 or 4) [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Periventricular leukomalacia [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Bronchopulmonary dysplasia [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Peak transcutaneous and/or serum bilirubin concentrations [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: Yes ]
  • Phototherapy [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: Yes ]
    Requirement and length of phototherapy
  • Ionotropic support [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
    Requirement and length of ionotropic support
  • NICU length of stay [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Sepsis [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Necrotizing enterocolitis [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Respiratory distress syndrome [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Number of blood transfusions while in the NICU [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Ventilator time [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Apgar score <7 at 5 minutes [ Time Frame: at 5 minutes after birth ] [ Designated as safety issue: Yes ]
  • Umbilical cord pH < 7.0 [ Time Frame: up to 30 minutes after birth ] [ Designated as safety issue: Yes ]
  • Blood pressure on admission to NICU [ Time Frame: at 30 minutes after birth ] [ Designated as safety issue: No ]
  • Polycythemia [ Time Frame: up to 24 hours of life ] [ Designated as safety issue: Yes ]
  • Hematocrit on admission to NICU [ Time Frame: up to 4 hours after birth ] [ Designated as safety issue: No ]
  • Neonatal death [ Time Frame: up to 24 weeks of life ] [ Designated as safety issue: No ]
  • Length of 3rd stage of labor [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
    Time period between delivery of the baby and delivery of the placenta
  • Use of uterotonic agents [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
  • Maternal blood transfusion [ Time Frame: up to 5 days after delivery ] [ Designated as safety issue: Yes ]
  • Manual removal of placenta [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
  • Operating time for cesarean delivery [ Time Frame: up to 3 hours after birth ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Premature Birth
  • Procedure: Delayed cord clamping
    Delay cord clamping for 30 seconds after birth
  • Procedure: Milking of the cord
    Milking of the cord 4 times in 10 seconds
  • Experimental: Delayed cord clamping
    Delayed cord clamping for 30 seconds
    Intervention: Procedure: Delayed cord clamping
  • Experimental: Milking of the cord
    Milking of the cord 4 times in 10 seconds
    Intervention: Procedure: Milking of the cord
  • No Intervention: Immediate cord clamping
    Immediate cord clamping after delivery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
January 2013
January 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01393834
2011-053
Yes
Medstar Research Institute
Medstar Research Institute
Not Provided
Principal Investigator: Rita W Driggers, MD Washington Hospital Center, Georgetown University Hospital
Medstar Research Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP