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Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT01393834
Collaborator
(none)
2
Enrollment
3
Arms
13
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Delayed cord clamping
  • Procedure: Milking of the cord
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Delayed cord clamping

Delayed cord clamping for 30 seconds

Procedure: Delayed cord clamping
Delay cord clamping for 30 seconds after birth
Experimental: Milking of the cord

Milking of the cord 4 times in 10 seconds

Procedure: Milking of the cord
Milking of the cord 4 times in 10 seconds
No Intervention: Immediate cord clamping

Immediate cord clamping after delivery

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Maternal estimated blood loss [up to 1 hour after delivery]

    Estimated blood loss at delivery

  2. Any grade intraventricular hemorrhage [up to 24 weeks after birth]

  3. Severe intraventricular hemorrhage (grade 3 or 4) [up to 24 weeks after birth]

  4. Periventricular leukomalacia [up to 24 weeks after birth]

  5. Bronchopulmonary dysplasia [up to 24 weeks after birth]

  6. Peak transcutaneous and/or serum bilirubin concentrations [up to 24 weeks after birth]

  7. Phototherapy [up to 24 weeks after birth]

    Requirement and length of phototherapy

  8. Ionotropic support [up to 24 weeks after birth]

    Requirement and length of ionotropic support

  9. Neonatal intesive care unit (NICU) length of stay [up to 24 weeks after birth]

  10. Sepsis [up to 24 weeks after birth]

  11. Necrotizing enterocolitis [up to 24 weeks after birth]

  12. Respiratory distress syndrome [up to 24 weeks after birth]

  13. Number of blood transfusions while in the neonatal intensive care unit [up to 24 weeks after birth]

  14. Ventilator time [up to 24 weeks after birth]

  15. Apgar score <7 at 5 minutes [at 5 minutes after birth]

  16. Umbilical cord pH < 7.0 [up to 30 minutes after birth]

  17. Blood pressure on admission to neonatal intensive care unit [at 30 minutes after birth]

  18. Polycythemia [up to 24 hours of life]

  19. Hematocrit on admission to neonatal intensive care unit [up to 4 hours after birth]

  20. Neonatal death [up to 24 weeks of life]

  21. Length of 3rd stage of labor [up to 1 hour after birth]

    Time period between delivery of the baby and delivery of the placenta

  22. Use of uterotonic agents [up to 1 hour after birth]

  23. Maternal blood transfusion [up to 5 days after delivery]

  24. Manual removal of placenta [up to 1 hour after birth]

  25. Operating time for cesarean delivery [up to 3 hours after birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medstar Health Research Institute

Investigators

  • Principal Investigator: Rita W Driggers, MD, Washington Hospital Center, Georgetown University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT01393834
Other Study ID Numbers:
  • 2011-053
First Posted:
Jul 13, 2011
Last Update Posted:
Feb 22, 2013
Last Verified:
Feb 1, 2013
Keywords provided by Medstar Health Research Institute
Delayed cord clamping
Umbilical cord
Preterm
Cord milking
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Feb 22, 2013