Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
NCT ID: NCT03657394
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
3442 participants
INTERVENTIONAL
2022-10-17
2026-02-28
Brief Summary
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Detailed Description
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Preliminary evidence suggests a placental transfusion in term infants may be a neuroprotective mechanism that can also facilitate cardiovascular transition for neonates depressed at birth and result in decreased mortality and improved neurodevelopmental outcomes. Infants with HIE, due to varied complications during the birth process, have poor perfusion due to fetal blood volume loss to the placenta. However, the most common method of providing placental blood, delayed cord clamping (DCC) cannot be performed since infants with HIE are non-vigorous and providers often need to perform resuscitation immediately after birth. The World Health Organization and the American College of Obstetrics and Gynecology (ACOG) also does not recommended DCC in neonates who are non-vigorous (limp, pale, and not breathing) at birth and require immediate resuscitation. Umbilical cord milking (UCM) or gently squeezing cord blood toward the baby, is an alternative to DCC, which can achieve significant placental transfusion without delaying resuscitation. Further, UCM can be completed as quickly as immediate cord clamping (ICC) and UCM requires minimal training and no additional staff.
The investigators hypothesized that UCM will reduce the number of infants developing moderate to severe HIE or death in neonates who are non-vigorous at birth compared to early cord clamping (ECC). This will be a cluster crossover randomized controlled trial. Each hospital will be randomly assigned to use either ECC or UCM for any infant who is non-vigorous at birth and needing resuscitation over a period of 6 months. Then the site will change to the other method for an additional 6 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Umbilical Cord Milking
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC.
Umbilical cord milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.
Early Cord Clamping
Umbilical cord will be clamped immediately after birth (within 60 seconds)
No interventions assigned to this group
Interventions
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Umbilical cord milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Chromosomal abnormalities.
* Major congenital malformations.
* Abruption/cutting through the placenta at delivery.
* Umbilical cord knots or inadequate cord length.
* Mono-chorionic twins or twins with no information on amnion/chorion.
* Multiple gestation \>2 .
35 Weeks
42 Weeks
ALL
No
Sponsors
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Sharp HealthCare
OTHER
Thomas Jefferson University
OTHER
University of San Diego
OTHER
St. Louis University
OTHER
Jawaharlal Nehru Medical College
OTHER
Daga Memorial Maternity and Children's Hospital, Nagpur, India
UNKNOWN
Mahatma Gandhi Institue of Medical Sciences, Wardha, India
UNKNOWN
Karnataka Institue of Medical Sciences, Hubbali, India
UNKNOWN
Jawaharlal Institute of Postgraduate Medical Education & Research
OTHER_GOV
All India Institute of Medical Sciences
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Indira Gandhi Government Medical College & Hospital, Nagpur, India
UNKNOWN
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
UNKNOWN
Government Medical College, Nagpur
INDUSTRY
Nemours Children's Clinic
OTHER
Responsible Party
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Zubair Aghai
Professor Of Pediatrics
Principal Investigators
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Zubair H Aghai, MD
Role: PRINCIPAL_INVESTIGATOR
Nemours Children's Clinic
Anup Katheria, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp Mary Birch Hospital for Women & Newborns
Sangappa Dhaded, MD
Role: PRINCIPAL_INVESTIGATOR
KLE Academy of Higher Education and Research
Locations
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KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi, Karnataka, India
Indira Gandhi Government Medical College & Hospital
Nagpur, Maharashtra, India
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra, India
Government Medical College
Chandrapur, MS, India
Daga Memorial Woman and Children Hospital
Nagpur, MS, India
Government Medical College and Hospital
Nagpur, MS, India
All India Institute of Medical Science
Nagpur, MS, India
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha, MS, India
Sawai Man Singh (SMS) Medical College
Jaipur, Rajasthan, India
Countries
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Other Identifiers
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CORDMILK
Identifier Type: -
Identifier Source: org_study_id