Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

Premature Birth Clinical Trial

Official title:

Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01393834
• Other study ID #: 2011-053
• Status: Terminated
• Phase: N/A
• First received: June 1, 2011
• Last updated: February 20, 2013
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Premature Birth

Intervention

Procedure:
• Delayed cord clamping
Delay cord clamping for 30 seconds after birth
• Milking of the cord
Milking of the cord 4 times in 10 seconds

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 24 weeks after birth	No
Secondary	Maternal estimated blood loss	Estimated blood loss at delivery	up to 1 hour after delivery	Yes
Secondary	Any grade intraventricular hemorrhage		up to 24 weeks after birth	No
Secondary	Severe intraventricular hemorrhage (grade 3 or 4)		up to 24 weeks after birth	No
Secondary	Periventricular leukomalacia		up to 24 weeks after birth	No
Secondary	Bronchopulmonary dysplasia		up to 24 weeks after birth	No
Secondary	Peak transcutaneous and/or serum bilirubin concentrations		up to 24 weeks after birth	Yes
Secondary	Phototherapy	Requirement and length of phototherapy	up to 24 weeks after birth	Yes
Secondary	Ionotropic support	Requirement and length of ionotropic support	up to 24 weeks after birth	No
Secondary	Neonatal intesive care unit (NICU) length of stay		up to 24 weeks after birth	No
Secondary	Sepsis		up to 24 weeks after birth	No
Secondary	Necrotizing enterocolitis		up to 24 weeks after birth	No
Secondary	Respiratory distress syndrome		up to 24 weeks after birth	No
Secondary	Number of blood transfusions while in the neonatal intensive care unit		up to 24 weeks after birth	No
Secondary	Ventilator time		up to 24 weeks after birth	No
Secondary	Apgar score <7 at 5 minutes		at 5 minutes after birth	Yes
Secondary	Umbilical cord pH < 7.0		up to 30 minutes after birth	Yes
Secondary	Blood pressure on admission to neonatal intensive care unit		at 30 minutes after birth	No
Secondary	Polycythemia		up to 24 hours of life	Yes
Secondary	Hematocrit on admission to neonatal intensive care unit		up to 4 hours after birth	No
Secondary	Neonatal death		up to 24 weeks of life	No
Secondary	Length of 3rd stage of labor	Time period between delivery of the baby and delivery of the placenta	up to 1 hour after birth	Yes
Secondary	Use of uterotonic agents		up to 1 hour after birth	Yes
Secondary	Maternal blood transfusion		up to 5 days after delivery	Yes
Secondary	Manual removal of placenta		up to 1 hour after birth	Yes
Secondary	Operating time for cesarean delivery		up to 3 hours after birth	Yes