NCT01393834

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

June 1, 2011

Last Update Submit

February 20, 2013

Conditions

Premature Birth

Keywords

Delayed cord clampingUmbilical cordPretermCord milking

Outcome Measures

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

    up to 24 weeks after birth

Secondary Outcomes (25)

  • Maternal estimated blood loss

    up to 1 hour after 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

  • +20 more secondary outcomes

Study Arms (3)

Delayed cord clamping

EXPERIMENTAL

Delayed cord clamping for 30 seconds

Procedure: Delayed cord clamping

Milking of the cord

EXPERIMENTAL

Milking of the cord 4 times in 10 seconds

Procedure: Milking of the cord

Immediate cord clamping

NO INTERVENTION

Immediate cord clamping after delivery

Interventions

Delayed cord clampingPROCEDURE

Delay cord clamping for 30 seconds after birth

Delayed cord clamping
Milking of the cordPROCEDURE

Milking of the cord 4 times in 10 seconds

Milking of the cord

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Rita W Driggers, MD

    Washington Hospital Center, Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

July 13, 2011

Study Start

December 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 22, 2013

Record last verified: 2013-02