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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cord milking | Other | milking of the umbilical cord 5 times toward the neonate |
|
| delayed cord clamping | Other | delayed cord clamping for 120 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cord milking | Procedure | milking of the cord 5 times toward the neonate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Hemoglobin Level | neonatal 6 weeks hemoglobin measured in gram % | 6 weeks after labor |
| Measure | Description | Time Frame |
|---|---|---|
| Jundice Requring Phtotherapy | number of infants requiring phtotherapy for jundice in the first 2 weeks | two weks |
| Severe Postpartum Haemorrage | (measured blood loss 1000 mL or more |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hazem F El Shahawy, PHD | clinical professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Chams University Maternity Hospital | Cairo | Cairo Governorate | 02 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19211831 | Background | 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. | |
| 16782490 | 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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lecture and seminar
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No significant events following participants recruitment
The current RCT was conducted at Ain Shams University Maternity Hospital during the period between August 2015 to February 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Cord Milking | milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds |
| FG001 | Delayed Cord Clamping | delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Cord Milking | milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds |
| BG001 | Delayed Cord Clamping | delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neonatal Hemoglobin Level | neonatal 6 weeks hemoglobin measured in gram % | Number of Infants Analyzed | Posted | Mean | Standard Deviation | gram% | 6 weeks after labor |
|
6 MONTHS
Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cord Milking | milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| post partum haemorrage | Blood and lymphatic system disorders | Systematic Assessment | loss of more than 1000 ml of blood after delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| need for blood trasnfusion | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ahmed kotb | AinShamsU | 0100868199 | +2 | ahmedmkotp@hotmail.com |
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| ID | Term |
|---|---|
| D000751 | Anemia, Neonatal |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| delayed cord clamping | Procedure | delay clamping of the cord for 120 seconds |
|
| 24 hours after labor |
| Neonatal Intubation | number of newborns requirng intubation in the first 2 hours after delivery | 1st 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 | 1st 24 hours after delivery |
| Neonatal Apgar Score (After 5 Minutes of Delivery). |
| 5 minutes of delivery |
| Maternal Need for Blood Transfusion. | number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion | 1st 24 hours after delivery |
| 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 |
| Duration of Third Stage of Labor | number of minutes from delivery of the baby till delivery of the placenta | immediatly after delivery |
| 19555916 | Background | 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. |
| 15510946 | Background | 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. |
| 17374818 | 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. |
| Background | Inch S. Management of the third stage of labour: another cascade of intervention?. Midwifery 1985;1:114-22. |
| 5015327 | Background | 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. |
| 17413089 | Background | 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. |
| Background | .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. |
| 11783688 | 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. |
| Background | .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. |
| 15495045 | 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. |
| 17890882 | 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. |
| Background | .Smith J, Brennan BG. Management of the third stage of labor. EMedicine from WebMD (last updated 27 June 2006) (accessed 28 January 2007). |
| 20410098 | Background | 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. |
| 11135798 | Background | 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. |
| 19267295 | Background | 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. |
| 17082547 | Background | 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. |
| 4588934 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Jundice Requring Phtotherapy | number of infants requiring phtotherapy for jundice in the first 2 weeks | Number of Infants Analyzed | Posted | Number | participants | two weks |
|
|
|
| Secondary | Severe Postpartum Haemorrage | (measured blood loss 1000 mL or more | Posted | Number | participants | 24 hours after labor |
|
|
|
| Secondary | Neonatal Intubation | number of newborns requirng intubation in the first 2 hours after delivery | Number of Infants Analyzed | Posted | Number | participants | 1st 2 hours after delivery |
|
|
|
| Secondary | Neonatal Intensive Care Unit (NICU) Admission | number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery | Number of Infants Analyzed | Posted | Number | participants | 1st 24 hours after delivery |
|
|
|
| Secondary | Neonatal Apgar Score (After 5 Minutes of Delivery). |
| Number of Infants Analyzed | Posted | Mean | Standard Deviation | Scores on a Scale from 1 to 10 | 5 minutes of delivery |
|
|
|
| Secondary | Maternal Need for Blood Transfusion. | number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion | Posted | Number | participants | 1st 24 hours after delivery |
|
|
|
| Secondary | Maternal Additional Need for Therapeutic Uterotonics | number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery | Posted | Number | participants | 1st 24 hours of delivery |
|
|
|
| Secondary | Duration of Third Stage of Labor | number of minutes from delivery of the baby till delivery of the placenta | Posted | Mean | Standard Deviation | minutes | immediatly after delivery |
|
|
|
| 4 |
| 145 |
| 12 |
| 145 |
| EG001 | Delayed Cord Clamping | delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate | 2 | 143 | 14 | 143 |
|
| Need for manual Removal of the placenta | Surgical and medical procedures | Systematic Assessment |
|
| Need for Therapeutic Uterotonics | Surgical and medical procedures | Systematic Assessment |
|
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| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |