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TerminatedNCT01393834Updated Feb 22, 2013

Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

An interventional study of Delayed cord clamping and Milking of the cord in Premature Birth, sponsored by Medstar Health Research Institute. Terminated. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-22.

Sponsored by Medstar Health Research Institute · Not applicable and Interventional

Why this study was terminated
difficulty with enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Premature Birth

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Keywords

  • Delayed cord clamping
  • Umbilical cord
  • Preterm
  • Cord milking
03

In context

Premature Birth

2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 2 is below the median of 84 across 1,691 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Delayed cord clamping

    Delayed cord clamping for 30 seconds

    Procedure: Delayed cord clamping

  • Experimental
    Milking of the cord

    Milking of the cord 4 times in 10 seconds

    Procedure: Milking of the cord

  • No intervention
    Immediate cord clamping

    Immediate cord clamping after delivery

Interventions

  • ProcedureDelayed cord clamping

    Delay cord clamping for 30 seconds after birth

  • ProcedureMilking of the cord

    Milking of the cord 4 times in 10 seconds

06

What researchers measure

Primary outcomes

  1. Adverse Neonatal Event

    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

    Time frame: up to 24 weeks after birth

Secondary outcomes

  1. Maternal estimated blood loss

    Estimated blood loss at delivery

    Time frame: up to 1 hour after delivery

  2. Any grade intraventricular hemorrhage

    Time frame: up to 24 weeks after birth

  3. Severe intraventricular hemorrhage (grade 3 or 4)

    Time frame: up to 24 weeks after birth

  4. Periventricular leukomalacia

    Time frame: up to 24 weeks after birth

  5. Bronchopulmonary dysplasia

    Time frame: up to 24 weeks after birth

  6. Peak transcutaneous and/or serum bilirubin concentrations

    Time frame: up to 24 weeks after birth

  7. Phototherapy

    Requirement and length of phototherapy

    Time frame: up to 24 weeks after birth

  8. Ionotropic support

    Requirement and length of ionotropic support

    Time frame: up to 24 weeks after birth

  9. Neonatal intesive care unit (NICU) length of stay

    Time frame: up to 24 weeks after birth

  10. Sepsis

    Time frame: up to 24 weeks after birth

  11. Necrotizing enterocolitis

    Time frame: up to 24 weeks after birth

  12. Respiratory distress syndrome

    Time frame: up to 24 weeks after birth

  13. Number of blood transfusions while in the neonatal intensive care unit

    Time frame: up to 24 weeks after birth

  14. Ventilator time

    Time frame: up to 24 weeks after birth

  15. Apgar score <7 at 5 minutes

    Time frame: at 5 minutes after birth

  16. Umbilical cord pH < 7.0

    Time frame: up to 30 minutes after birth

  17. Blood pressure on admission to neonatal intensive care unit

    Time frame: at 30 minutes after birth

  18. Polycythemia

    Time frame: up to 24 hours of life

  19. Hematocrit on admission to neonatal intensive care unit

    Time frame: up to 4 hours after birth

  20. Neonatal death

    Time frame: up to 24 weeks of life

  21. Length of 3rd stage of labor

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

    Time frame: up to 1 hour after birth

  22. Use of uterotonic agents

    Time frame: up to 1 hour after birth

  23. Maternal blood transfusion

    Time frame: up to 5 days after delivery

  24. Manual removal of placenta

    Time frame: up to 1 hour after birth

  25. Operating time for cesarean delivery

    Time frame: up to 3 hours after birth

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01393834
Lead sponsor
Medstar Health Research Institute
Responsible party
Sponsor
First posted
Jul 13, 2011
Start date
Dec 2011
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Feb 22, 2013

Study contacts

Rita W Driggers, MD
principal investigator · Washington Hospital Center, Georgetown University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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