Milking Versus Delayed Cord Clamping in Full Term Neonates

Neonatal Anemia Clinical Trial

— MDCCT  

Official title:

Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454101
• Other study ID #: delayed cord clamping in term
• Status: Completed
• Phase: N/A
• First received: May 17, 2015
• Last updated: March 7, 2016
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Description:

Abstract Context: milking of the umbilical cord toward the neonate 5 times and delayed cord clamping both are good procedures to prevent anemia in neonates .

Objective: To investigate the effects of delayed umbilical cord clamping for 120 seconds, compared with milking of the cord 5 times toward the neonate on hemoglobin level after 6 weeks, Intubation,Respiratory distress,Clinical jaundice,Neonatal Intensive Care unit (NICU) admission,Apgar score (after 5 minutes of delivery).

-Maternal,Need for blood transfusion,Additional need for therapeutic uterotonics,Post postpartum hemorrhage (blood loss > 500cc),Intensive Care unit admission.

Design: Randomized controlled trial. Setting: Ain Shams university maternity hospital. Participants:300 full term infants born after a low risk pregnancy by cesarean section delivery.

Intervention: Infants were randomized to delayed umbilical cord clamping (≥120 seconds after delivery) or cord milking (5 times to ward the neonate).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Medically free

Exclusion Criteria:

• Known congenital anomalies of fetus.

• Rhesus sensitization.

• Fetal hydrops.

• Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE).

• Need for urgent resuscitation.

• Multiple pregnancies.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia, Neonatal
• Neonatal Anemia

Intervention

Procedure:
• cord milking
milking of the cord 5 times toward the neonate
• delayed cord clamping
delay clamping of the cord for 120 seconds

Locations

Country	Name	City	State
Egypt	Ain Chams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Mohamed El Kotb Abdel Fattah

Country where clinical trial is conducted

Egypt, 

References & Publications (19)

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.Prendiville W, Elbourne D. Care during the third stage of labour. In: Chalmers I, Enkin M, Keirse MJNC editor(s). Effective care in pregnancy and childbirth. Oxford: Oxford University Press, 1989: 1145-69.

.Smith J, Brennan BG. Management of the third stage of labor. EMedicine from WebMD (last updated 27 June 2006) (accessed 28 January 2007).

Carlson ES, Tkac I, Magid R, O'Connor MB, Andrews NC, Schallert T, Gunshin H, Georgieff MK, Petryk A. Iron is essential for neuron development and memory function in mouse hippocampus. J Nutr. 2009 Apr;139(4):672-9. doi: 10.3945/jn.108.096354. Epub 2009 Feb 11. — View Citation

Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Líz 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. — View Citation

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. Review. — View Citation

Emhamed MO, van Rheenen P, Brabin BJ. The early effects of delayed cord clamping in term infants born to Libyan mothers. Trop Doct. 2004 Oct;34(4):218-22. — View Citation

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. Review. — View Citation

Inch S. Management of the third stage of labour: another cascade of intervention?. Midwifery 1985;1:114-22.

Ladipo OA. Management of third stage of labour, with particular reference to reduction of feto-maternal transfusion. Br Med J. 1972 Mar 18;1(5802):721-3. — View Citation

McCann JC, Ames BN. An overview of evidence for a causal relation between iron deficiency during development and deficits in cognitive or behavioral function. Am J Clin Nutr. 2007 Apr;85(4):931-45. Review. — View Citation

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. Review. — View Citation

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. Epub 2007 Sep 21. Review. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2012;8:CD003248. — View Citation

Szajewska H, Ruszczynski M, Chmielewska A. Effects of iron supplementation in nonanemic pregnant women, infants, and young children on the mental performance and psychomotor development of children: a systematic review of randomized controlled trials. Am J Clin Nutr. 2010 Jun;91(6):1684-90. doi: 10.3945/ajcn.2010.29191. Epub 2010 Apr 21. Review. — View Citation

Thane CW, Walmsley CM, Bates CJ, Prentice A, Cole TJ. Risk factors for poor iron status in British toddlers: further analysis of data from the National Diet and Nutrition Survey of children aged 1.5-4.5 years. Public Health Nutr. 2000 Dec;3(4):433-40. — View Citation

Thomas DG, Grant SL, Aubuchon-Endsley NL. The role of iron in neurocognitive development. Dev Neuropsychol. 2009;34(2):196-222. doi: 10.1080/87565640802646767. Review. — View Citation

van Rheenen PF, Brabin BJ. A practical approach to timing cord clamping in resource poor settings. BMJ. 2006 Nov 4;333(7575):954-8. — View Citation

Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neonatal hemoglobin level	neonatal 6 weeks hemoglobin measured in gram/dl	6 weeks after labor	Yes
Secondary	jaundice requring phtotherapy	number of infants requiring phototherapy for jundice in the first 2 weeks	two weks	Yes
Secondary	Severe postpartum haemorrage	(measured blood loss 1000 mL or more	24 hours after labor	Yes
Secondary	neonatal intubation	number of newborns requirng intubation in the first 2 hours after delivery	1st 2 hours after delivery	Yes
Secondary	Neonatal Intensive Care unit (NICU) admission	number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery	1st 24 hours after delivery	Yes
Secondary	neonatal Apgar score (after 5 minutes of delivery).	neonatal Apgar score after 5 minutes of delivery	5 minutes of delivery	Yes
Secondary	maternal Need for blood transfusion.	number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion	1st 24 hours after delivery	Yes
Secondary	maternal additional need for therapeutic uterotonics	number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery	1st 24 hours of delivery	Yes
Secondary	duration of third stage of labor	number of minutes from delivery of the baby till delivery of the placenta	immediatly after delivery	Yes