Milking Versus Delayed Cord Clamping in Full Term Neonates (MDCCT)
Primary Purpose
Neonatal Anemia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cord milking
delayed cord clamping
Sponsored by
About this trial
This is an interventional supportive care trial for Neonatal Anemia
Eligibility Criteria
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.
Sites / Locations
- Ain Chams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
cord milking
delayed cord clamping
Arm Description
milking of the umbilical cord 5 times toward the neonate
delayed cord clamping for 120 seconds
Outcomes
Primary Outcome Measures
Neonatal Hemoglobin Level
neonatal 6 weeks hemoglobin measured in gram %
Secondary Outcome Measures
Jundice Requring Phtotherapy
number of infants requiring phtotherapy for jundice in the first 2 weeks
Severe Postpartum Haemorrage
(measured blood loss 1000 mL or more
Neonatal Intubation
number of newborns requirng intubation in the first 2 hours after delivery
Neonatal Intensive Care Unit (NICU) Admission
number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery
Neonatal Apgar Score (After 5 Minutes of Delivery).
The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's:
Breathing effort
Heart rate
Muscle tone
Reflexes
Skin color
Each category is scored with 0, 1, or 2, depending on the observed condition.
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.
A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.
Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs
Maternal Need for Blood Transfusion.
number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion
Maternal Additional Need for Therapeutic Uterotonics
number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery
Duration of Third Stage of Labor
number of minutes from delivery of the baby till delivery of the placenta
Full Information
NCT ID
NCT02454101
First Posted
May 17, 2015
Last Updated
May 19, 2016
Sponsor
Ahmed Mohamed El Kotb Abdel Fattah
1. Study Identification
Unique Protocol Identification Number
NCT02454101
Brief Title
Milking Versus Delayed Cord Clamping in Full Term Neonates
Acronym
MDCCT
Official Title
Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed El Kotb Abdel Fattah
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Anemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cord milking
Arm Type
Other
Arm Description
milking of the umbilical cord 5 times toward the neonate
Arm Title
delayed cord clamping
Arm Type
Other
Arm Description
delayed cord clamping for 120 seconds
Intervention Type
Procedure
Intervention Name(s)
cord milking
Other Intervention Name(s)
milking of the cord
Intervention Description
milking of the cord 5 times toward the neonate
Intervention Type
Procedure
Intervention Name(s)
delayed cord clamping
Intervention Description
delay clamping of the cord for 120 seconds
Primary Outcome Measure Information:
Title
Neonatal Hemoglobin Level
Description
neonatal 6 weeks hemoglobin measured in gram %
Time Frame
6 weeks after labor
Secondary Outcome Measure Information:
Title
Jundice Requring Phtotherapy
Description
number of infants requiring phtotherapy for jundice in the first 2 weeks
Time Frame
two weks
Title
Severe Postpartum Haemorrage
Description
(measured blood loss 1000 mL or more
Time Frame
24 hours after labor
Title
Neonatal Intubation
Description
number of newborns requirng intubation in the first 2 hours after delivery
Time Frame
1st 2 hours after delivery
Title
Neonatal Intensive Care Unit (NICU) Admission
Description
number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery
Time Frame
1st 24 hours after delivery
Title
Neonatal Apgar Score (After 5 Minutes of Delivery).
Description
The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's:
Breathing effort
Heart rate
Muscle tone
Reflexes
Skin color
Each category is scored with 0, 1, or 2, depending on the observed condition.
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.
A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.
Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs
Time Frame
5 minutes of delivery
Title
Maternal Need for Blood Transfusion.
Description
number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion
Time Frame
1st 24 hours after delivery
Title
Maternal Additional Need for Therapeutic Uterotonics
Description
number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery
Time Frame
1st 24 hours of delivery
Title
Duration of Third Stage of Labor
Description
number of minutes from delivery of the baby till delivery of the placenta
Time Frame
immediatly after delivery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem F El Shahawy, PHD
Organizational Affiliation
clinical professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Chams University Maternity Hospital
City
Cairo
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
lecture and seminar
Citations:
PubMed Identifier
19211831
Citation
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.
Results Reference
background
PubMed Identifier
16782490
Citation
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.
Results Reference
background
PubMed Identifier
19555916
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. No abstract available.
Results Reference
background
PubMed Identifier
15510946
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. doi: 10.1177/004947550403400410.
Results Reference
background
PubMed Identifier
17374818
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. doi: 10.1001/jama.297.11.1241.
Results Reference
background
Citation
Inch S. Management of the third stage of labour: another cascade of intervention?. Midwifery 1985;1:114-22.
Results Reference
background
PubMed Identifier
5015327
Citation
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. doi: 10.1136/bmj.1.5802.721.
Results Reference
background
PubMed Identifier
17413089
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. doi: 10.1093/ajcn/85.4.931.
Results Reference
background
Citation
.McDonald S. Physiology and management of the third stage of labour. In: Fraser D, Cooper M editor(s). Myles textbook for mid- wives. 14th Edition. Edinburgh: Churchill Livingstone, 2003.
Results Reference
background
PubMed Identifier
11783688
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. doi: 10.1016/s1526-9523(01)00196-9.
Results Reference
background
Citation
.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.
Results Reference
background
PubMed Identifier
15495045
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. doi: 10.1002/14651858.CD003248.pub2.
Results Reference
background
PubMed Identifier
17890882
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. doi: 10.1159/000108764. Epub 2007 Sep 21.
Results Reference
background
Citation
.Smith J, Brennan BG. Management of the third stage of labor. EMedicine from WebMD (last updated 27 June 2006) (accessed 28 January 2007).
Results Reference
background
PubMed Identifier
20410098
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.
Results Reference
background
PubMed Identifier
11135798
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. doi: 10.1017/s1368980000000501.
Results Reference
background
PubMed Identifier
19267295
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.
Results Reference
background
PubMed Identifier
17082547
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. doi: 10.1136/bmj.39002.389236.BE. No abstract available.
Results Reference
background
PubMed Identifier
4588934
Citation
Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. doi: 10.1001/archpedi.1974.02110200130021. No abstract available.
Results Reference
background
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Milking Versus Delayed Cord Clamping in Full Term Neonates
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