Milking Versus Delayed Cord Clamping in Full Term Neonates

NCT02454101 | Completed Results

• 1 other identifier: delayed cord clamping in term
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the short term risks and benefits of cord milking 5 times toward the neonate with delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.

Conditions

Neonatal Anemia

Outcome Measures

Primary Outcomes (1)

• Neonatal Hemoglobin Level

  neonatal 6 weeks hemoglobin measured in gram %

  6 weeks after labor

Secondary Outcomes (8)

• Jundice Requring Phtotherapy

  two weks

• Severe Postpartum Haemorrage

  24 hours after labor

• Neonatal Intubation

  1st 2 hours after delivery

• Neonatal Intensive Care Unit (NICU) Admission

  1st 24 hours after delivery

• Neonatal Apgar Score (After 5 Minutes of Delivery).

  5 minutes of delivery

Study Arms (2)

cord milking

OTHER

milking of the umbilical cord 5 times toward the neonate

Procedure: delayed cord clamping

delayed cord clamping

OTHER

delayed cord clamping for 120 seconds

Procedure: cord milking

Interventions

cord milking PROCEDURE

milking of the cord 5 times toward the neonate

Also known as: milking of the cord

delayed cord clamping

delayed cord clamping PROCEDURE

delay clamping of the cord for 120 seconds

cord milking

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant females going for cesarean section that completed 37 weeks of gestation
• Medically free

You may not qualify if:

• Known congenital anomalies of fetus.
• Rhesus sensitization.
• Fetal hydrops.
• Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE).
• Need for urgent resuscitation.
• Multiple pregnancies.

Sponsors & Collaborators

• Ahmed Mohamed El Kotb Abdel Fattah: lead

Study Sites (1)

Ain Chams University Maternity Hospital

Cairo, Cairo Governorate, 02, Egypt

Location

Related Publications (19)

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  PMID: 19211831 BACKGROUND

• Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Liz Cedillo R, Dewey KG. Effect of timing of umbilical cord clamping on iron status in Mexican infants: a randomised controlled trial. Lancet. 2006 Jun 17;367(9527):1997-2004. doi: 10.1016/S0140-6736(06)68889-2.

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• Eichenbaum-Pikser G, Zasloff JS. Delayed clamping of the umbilical cord: a review with implications for practice. J Midwifery Womens Health. 2009 Jul-Aug;54(4):321-6. doi: 10.1016/j.jmwh.2008.12.012. No abstract available.

  PMID: 19555916 BACKGROUND

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  PMID: 15510946 BACKGROUND

• Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.

  PMID: 17374818 BACKGROUND

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  BACKGROUND

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  PMID: 5015327 BACKGROUND

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  PMID: 17413089 BACKGROUND

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  BACKGROUND

• Mercer JS. Current best evidence: a review of the literature on umbilical cord clamping. J Midwifery Womens Health. 2001 Nov-Dec;46(6):402-14. doi: 10.1016/s1526-9523(01)00196-9.

  PMID: 11783688 BACKGROUND

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  BACKGROUND

• Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. doi: 10.1002/14651858.CD003248.pub2.

  PMID: 15495045 BACKGROUND

• Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.

  PMID: 17890882 BACKGROUND

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  BACKGROUND

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  PMID: 20410098 BACKGROUND

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  PMID: 4588934 BACKGROUND

MeSH Terms

Conditions

Anemia, Neonatal

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: ahmed kotb
• Organization: AinShamsU

ahmedmkotp@hotmail.com

0100868199

Study Officials

• Hazem F El Shahawy, PHD

  clinical professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: May 27, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 28, 2016
• Results First Posted: June 28, 2016

Record last verified: 2016-04

Locations

EG (1)