Neonatal AnemiaMDCCTNCT02454101
Milking Versus Delayed Cord Clamping in Full Term Neonates
A study testing cord milking and delayed cord clamping in people with Neonatal Anemia, run by Ahmed Mohamed El Kotb Abdel Fattah at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neonatal Anemia
- What is being tested?
- cord milking and delayed cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant females going for cesarean section that completed 37 weeks of gestation
- Medically free
Who cannot join
- Known congenital anomalies of fetus.
- Rhesus sensitization.
- Fetal hydrops.
- Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE).
- Need for urgent resuscitation.
- Multiple pregnancies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Chams University Maternity Hospital
Cairo, Cairo Governorate, 02
About this study
Official title: Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Neonatal Anemia
- Being tested
- cord milking, delayed cord clamping
- Medical subject headings
- Anemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cord milkingProcedure or surgery
Also called milking of the cord
milking of the cord 5 times toward the neonate
delayed cord clampingProcedure or surgery
delay clamping of the cord for 120 seconds
| Study group | Role | What they receive |
|---|---|---|
| cord milking | Other | milking of the umbilical cord 5 times toward the neonate Receives: Procedure: delayed cord clamping |
| delayed cord clamping | Other | delayed cord clamping for 120 seconds Receives: Procedure: cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Hemoglobin Level
neonatal 6 weeks hemoglobin measured in gram %
Measured: 6 weeks after labor
Secondary outcomes (8)
Jundice Requring Phtotherapy
number of infants requiring phtotherapy for jundice in the first 2 weeks
Measured: two weks
Severe Postpartum Haemorrage
(measured blood loss 1000 mL or more
Measured: 24 hours after labor
Neonatal Intubation
number of newborns requirng intubation in the first 2 hours after delivery
Measured: 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
Measured: 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
Measured: 5 minutes of delivery
Maternal Need for Blood Transfusion.
number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion
Measured: 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
Measured: 1st 24 hours of delivery
Duration of Third Stage of Labor
number of minutes from delivery of the baby till delivery of the placenta
Measured: immediatly after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Neonatal AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed El Kotb Abdel Fattah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
- Investigators
- Hazem F El Shahawy, PHD, Principal investigator, clinical professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454101
- Sponsor's protocol ID
- delayed cord clamping in term
- Acronym
- MDCCT
- Status last verified
- Apr 2016
- First submitted
- 17 May 2015
- Last updated
- 28 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: lecture and seminar
Publications
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.
PubMed 19211831Chaparro 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.
PubMed 16782490Eichenbaum-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.
PubMed 19555916Emhamed 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.
PubMed 15510946Hutton 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.
PubMed 17374818Inch 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. doi: 10.1136/bmj.1.5802.721.
PubMed 5015327McCann 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.
PubMed 17413089.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.
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.
PubMed 11783688.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.
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.
PubMed 15495045Rabe 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.
PubMed 17890882.Smith J, Brennan BG. Management of the third stage of labor. EMedicine from WebMD (last updated 27 June 2006) (accessed 28 January 2007).
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.
PubMed 20410098
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02454101
- Acronym / sponsor ID
- MDCCT / delayed cord clamping in term
- Conditions
- Neonatal Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ahmed Mohamed El Kotb Abdel FattahUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Posted 28 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cord milking | Other | Procedure: delayed cord clampingmilking of the umbilical cord 5 times toward the neonate |
| delayed cord clamping | Other | Procedure: cord milkingdelayed cord clamping for 120 seconds |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant females going for cesarean section that completed 37 weeks of gestation
- Medically free
Key exclusion criteria (6 listed)
- Known congenital anomalies of fetus.
- Rhesus sensitization.
- Fetal hydrops.
- Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE).
- Need for urgent resuscitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cord milkingAlso: milking of the cordmilking of the cord 5 times toward the neonate | Procedure or surgery | delayed cord clamping |
| delayed cord clampingdelay clamping of the cord for 120 seconds | Procedure or surgery | cord milking |
Primary outcome
Neonatal Hemoglobin Level
Time frame: 6 weeks after labor
neonatal 6 weeks hemoglobin measured in gram %
8 secondary outcomes
Jundice Requring Phtotherapy
Time frame: two weks
Severe Postpartum Haemorrage
Time frame: 24 hours after labor
Neonatal Intubation
Time frame: 1st 2 hours after delivery
Neonatal Intensive Care Unit (NICU) Admission
Time frame: 1st 24 hours after delivery
Neonatal Apgar Score (After 5 Minutes of Delivery).
Time frame: 5 minutes of delivery
Maternal Need for Blood Transfusion.
Time frame: 1st 24 hours after delivery
Maternal Additional Need for Therapeutic Uterotonics
Time frame: 1st 24 hours of delivery
Duration of Third Stage of Labor
Time frame: immediatly after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19211831Carlson 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.
- Background: PubMed 16782490Chaparro 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.
- Background: PubMed 19555916Eichenbaum-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.
- Background: PubMed 15510946Emhamed 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.
- Background: PubMed 17374818Hutton 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.
- BackgroundInch S. Management of the third stage of labour: another cascade of intervention?. Midwifery 1985;1:114-22.
- Background: PubMed 5015327Ladipo 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.
- Background: PubMed 17413089McCann 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.
- Background: PubMed 11783688Mercer 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.
- Background: PubMed 15495045Rabe 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.
- Individual participant dataSharing planned: Undecided. lecture and seminar
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazem F El Shahawy, PHD principal investigator
clinical professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cord milking and delayed cord clamping in people with Neonatal Anemia, run by Ahmed Mohamed El Kotb Abdel Fattah at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Hemoglobin Level (time frame: 6 weeks after labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454101, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.