Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

NCT03657394 | Active Not Recruiting DMC

• 2 other identifiers: CORDMILKR01HD102967
• Study Type: interventional
• Target: 3,442
• Locations: 1 country
• Sites: 9

Brief Summary

The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.

Conditions

Birth Asphyxia; Hypoxic-Ischemic Encephalopathy

Keywords

Placental transfusion

Outcome Measures

Primary Outcomes (1)

• Moderate to severe HIE or death

  Number of infants with moderate to severe HIE or death

  From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, asessed up to 10 weeks.

Secondary Outcomes (1)

• MRI of the brain

  4 days to 2 weeks

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

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.

Other: Umbilical cord milking

Early Cord Clamping

NO INTERVENTION

Umbilical cord will be clamped immediately after birth (within 60 seconds)

Interventions

Umbilical cord milking OTHER

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.

Umbilical Cord Milking

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Non-vigorous neonates born between 35-42 weeks

You may not qualify if:

• Congenital malformation of CNS.
• 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 .

Sponsors & Collaborators

• Jawaharlal Institute of Postgraduate Medical Education & Research: collaborator
• All India Institute of Medical Sciences: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Indira Gandhi Government Medical College & Hospital, Nagpur, India: collaborator
• Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India: collaborator
• Government Medical College, Nagpur: collaborator
• Sharp HealthCare: collaborator
• Nemours Children's Clinic: lead
• Thomas Jefferson University: collaborator
• University of San Diego: collaborator
• St. Louis University: collaborator
• Jawaharlal Nehru Medical College: collaborator
• Daga Memorial Maternity and Children's Hospital, Nagpur, India: collaborator
• Mahatma Gandhi Institue of Medical Sciences, Wardha, India: collaborator
• Karnataka Institue of Medical Sciences, Hubbali, India: collaborator

Study Sites (9)

KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590010, India

Location

Indira Gandhi Government Medical College & Hospital

Nagpur, Maharashtra, 440018, India

Location

Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital

Pune, Maharashtra, 411018, India

Location

Government Medical College

Chandrapur, MS, 442401, India

Location

Daga Memorial Woman and Children Hospital

Nagpur, MS, 440002, India

Location

Government Medical College and Hospital

Nagpur, MS, 440009, India

Location

All India Institute of Medical Science

Nagpur, MS, 441108, India

Location

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital

Wardha, MS, 442102, India

Location

Sawai Man Singh (SMS) Medical College

Jaipur, Rajasthan, 302004, India

Location

Related Publications (1)

• Yogeshkumar S, Vernekar SS, Dhaded SM, Talekar K, Leiby BE, Hartman R, Vaucher Y, Chouthai N, Girish M, Jain M, Jain S, Parvekar S, Jain V, Patankar A, Suryawanshi M, Tiwari M, Waikar M, Nashine N, Ambike D, Asalkar M, Kulkarni R, Haribhaktha S, Narkhede H, Chaudhari S, Kamble M, Shrirame D, Falke B, Mehta S, Verma A, Gothwal S, Goudar SS, Derman R, Katheria A, Aghai ZH. CORDMILK: Umbilical Cord Milking versus Early Cord Clamping on short-and long-term outcomes in neonates who are non-vigorous at birth-study protocol of a multi-center, cluster-randomized, crossover-controlled trial. Trials. 2025 Nov 17;26(1):509. doi: 10.1186/s13063-025-09197-8.

  PMID: 41250198 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Asphyxia Neonatorum; Fetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zubair H Aghai, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

• Anup Katheria, MD

  Sharp Mary Birch Hospital for Women & Newborns

  PRINCIPAL INVESTIGATOR

• Sangappa Dhaded, MD

  KLE Academy of Higher Education and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Pediatrics

Model Details: Cluster Randomized Crossover

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 5, 2018
• Study Start: October 17, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 28, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (9)