Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial
BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d7157 (Published 15 November 2011) Cite this as: BMJ 2011;343:d7157All rapid responses
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Dear Editor,
We thank Dr Rashmi R Das for the rapid response. Dr Das ask why we chose ≤ 10sec to define early cord clamping (ECC), and ≥ 180 sec to define delayed cord clamping (DCC).
Immediate clamping was the routine at the time for the study at the hospital where the study was performed. This was motivated by the need to obtain blood gas samples from the umbilical cord before the newborn started to breathe. A majority of hospitals in Sweden had the same routine in 2008, when the study was commenced.
As for delayed clamping, as Dr Das writes, it can be established that the transfusion from the placenta to the newborn takes up to 3 minutes, and that after that time there do not seem to be any more blood transferred. In our study, we wanted the transfusion to be as large as possible, to be able to study effects, both presumed and expected.
Dr Das correctly have remarks regarding scarcity of data on maternal morbidity and other factors from an obstetrical point of view. Among the factors Dr Das mentions are post-partum haemorrhage, risk of blood transfusion and duration of the third stage of labour.
In our paper we write that secondary outcomes “will be reported separately: maternal post-partum haemorrhage and rates of successful umbilical arterial blood samples in relation to allocation group”. This paper is in manuscript and will be submitted shortly, and here we will also report our findings on the mother’s risk of blood transfusion and duration of the third stage of labour.
Finally, Dr Das also misses a description about the neonates in the delayed cord clamping group who had Apgar score < 7 at one minute after delivery. According to the resuscitation protocol at the hospital, these newborns had their umbilical cord cut earlier than 180 seconds, and were handled in all means after what their condition needed. The results from these infants has been included in the delayed cord clamping group according to “intention to treat” although the protocol was not followed.
As Dr van Rheenen writes in the editorial accompanying this paper, it is suggested to delay clamping also in newborns that require immediate neonatal resuscitation. Although very interesting and important, we did not design our study for this outcome.
Competing interests: No competing interests
Dear Editor,
In a rapid response, Dr Saripanidis makes an elaborate review of data regarding long term outcomes of iron deficiency. We are glad that our research is called "excellent" and will take Dr Saripnidis call to follow these children up to the age of 10 under consideration. Although detail are not complete, we are in the process to plan further follow up.
Competing interests: No competing interests
Dear Editor,
Iron deficiency in infancy, with or without anaemia, is associated with impaired mental and psychomotor development [4][5][8][10][11][12][13][15][18][19][20][21][22][23][24][25][26][28][30], which persist despite long-term iron therapy [12][17][19][20][21][22][24][25][26][30][31], even up to 19 years of age [15][21][25].
Ferritin and circulating RBC volume measure hematologic effects in infants better than blood Hct. [1][6]
Low ferritin in infancy is associated with altered auditory recognition memory [3], diminished performance in mental and psychomotor tests at 5 years of age [2], alterations in visual attention and concept acquisition [7].
Iron deficiency in infancy has been associated to asthma [9], long term sleep alterations [14][19][26], slower eye-blinking rates [16], impaired upper-extremity motor functions [17], schizophrenia in adulthood [21], impaired social-emotional behaviour [23], long term altered prolactin responses [27], impaired auditory and visual responses [31].
Iron deficiency is very common, even in children from developed Countries. [4][5][8].
Delayed umbilical cord-clamping can reduce iron deficiency anaemia in term infants, even in industrialized Countries, and prevent all these long-term irreversible consequences [29].
The evidence for the usefulness of delayed umbilical cord-clamping is compelling.
NICE should impose delayed umbilical cord-clamping on mainstream obstetric practice.
Ethics Committees must no longer allow clinical studies where immediate umbilical cord-clamping is practiced.
Dear Authors,
Thank you for this excellent research.
Please follow up these children up to at least the age of 10, in order to assess auditory and visual functions, prolactin responses, social-emotional behaviour, motor functions, sleep patterns, schizophrenia and asthma incidence, intelligence quotients.
References
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Competing interests: No competing interests
Dr Griffiths concern regarding breast feeding rates are important, as breast feeding is known to be associated with several positive effects. In the paper, we report data regarding how many children that had started breast feeding at 1 and 6 hours of age, and the proportions of infants breastfeeding, exclusively or partially, at four months of age. We could not demonstrate any significant differences between groups at any of these time points.
At four months: 56% infants were exclusively breast fed in the delayed cord clamping group, and 51% in the early group. This can be compared with data from the Swedish "National Board of Health and Welfare" (1) that reports that 53% of all children born in 2009 were exclusively breast fed at four months of age (in the region of Halland, where the study was performed, the rate was 53.6%).
In summary, we can not find any indications that breast feeding rates were affected by either delayed or early cord clamping.
1. OFFICIAL STATISTICS OF SWEDEN. Statistics – Health and Medical Care: Breast-feeding and smoking habits among parents of infants
born in 2009
http://www.socialstyrelsen.se/Lists/Artikelkatalog/Attachments/18407/201...
Competing interests: No competing interests
Concerning the level of the baby relative to the uterus, available research could be summarized to: if the child is held at 20 cm or more under the uterus, the complete transfusion is performed within one minute, at +/- 10 cm of the level of the uterus the transfusion will take about three minutes, at 20 cm above the uterus the transfusion will be decreased to finally be stopped at a level of 40 cm above the uterus. Placing the baby at the mothers abdomen directly will perhaps diminish the transfusion (se ref 3), but there don't seem to be a risk for reverse transfusion.
In our study (1), the children in both clamping groups were held at approx 20 cm under the introitus for 30 seconds, and were then transfered to the mothers chest or abdomen. That is, the delay to "skin-to-skin" was 30 second in both groups. During this 30 seconds the midwife checked the babys vitality and wiped the baby briefly before moving the baby to the mother. This method was designed in collaboration with the staff at the OB department, including both midwives and obstetricians.
The effects of gravity was studied by Yao and Lind (2), I quote the abstract:
"The effect of gravity on placental transfusion was studied by measuring the placental residual blood volume (P.R.B.V.) in one hundred and twelve normal deliveries with the infants kept at different levels above or below the mother's introitus after birth. The results demonstrated that hydrostatic pressure, brought about by keeping the infant 40 cm. below the introitus, hastened placental transfusion to almost completion at about 30 seconds. In the presence of this effect of gravity, prolonging the time of cord clamping to 3 minutes did not result in a significantly larger amount of placental transfusion. Whereas, the effect of hydrostatic pressure created by having the infants held above the level of the mother's introitus lessened or prevented placental transfusion by partially or completely obliterating the pressure generated by uterine contraction."
Nelle et al (3) compared early cord clamping with delayed cord clamping after delivery according to the Leboyer method (directly placing the baby on the mothers abdomen) and concluded that about 20 ml/kg of extra blood was suggested to be transfered from the placenta to the child.
References:
1. Andersson O, Hellström-Westas L, Andersson D, Domellöf M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ 201; 343: d7157. doi:10.1136/bmj.d7157
2. Yao AC, Lind J. Effect of gravity on placental transfusion. Lancet. 1969 Sep 6;2(7619):505-8
3. Nelle M, Zilow EP, Kraus M, Bastert G, Linderkamp O. The effect of Leboyer delivery on blood viscosity and other hemorheologic parameters in term neonates. Am J Obstet Gynecol. 1993 Jul;169(1):189-93.
Competing interests: No competing interests
Dear Editor
I read with great interest the article by Anderson et al [1]. The authors have conducted a very good trial, but there few points that need comment.
It is not clear, why the authors have chosen ≤ 10sec to define early cord clamping (ECC), and ≥ 180 sec to define delayed cord clamping (DCC). The definitions have been variably used from < 30 sec to < 60 sec for ECC to ≥ 60 sec for DCC. This has important implication for clinical practice, as the time limit is wider in DCC. Actually, physiological studies have shown that there is a transfer from the placenta of about 80 ml of blood at 60 sec (1 min) after birth, reaching about 100 ml at 180 sec (3 minutes) after birth [2,3]. So, why to delay cord clamping for 3 min for getting an extra 20 ml blood, as the delay might increase maternal morbidity (by increasing the risk of post-partum hemorrhage, anemia, and fatigue), both being not studied by the present study [4]. Besides these, other factors not studied from obstetrical point of view are - preferences of personnel (maternal and neonatal) in the delivery team, risk of blood transfusion, manual removal of placenta, or duration of the third stage of labour. These can create an apparent conflict between the maternal and neonatal interest.
In Table – 1, The APGAR score in 3% of neonates in DCC group is < 7 (that is abnormal), that means these neonates might have required some resuscitation [5]. But there is no description about them in the whole paper. This is important and is an exception to DCC. So, future study should focus in addition, on important short - and longer - term neonatal and infant outcomes, such as neurodevelopment.
To conclude, implementation of this intervention would be particularly relevant in under-resourced settings, where access to good nutrition is limited during childhood. Future research should also be aimed at above factors, including women's views related to this intervention.
References
1. Andersson O, Hellström-Westas L, Andersson D, Domellöf M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ 201; 343: d7157. doi:10.1136/bmj.d7157.
2. Linderkamp O, Nelle M, Kraus M, Zilow EP. The effect of early and late cord-clamping on blood viscosity and other hemorheological parameters in full-term neonates. Acta Paediatrica 1992; 81: 745 – 50.
3. Yao AC, Lind J. Placental transfusion. American Journal of Diseases of Children. 1974; 127: 128 – 41.
4. Patterson A, Davis J, Gregory M, Holt S, Pachulski A, Stamford D, et al. A study of the effects of low haemoglobin on postnatal women. Midwifery 1994; 10: 77 – 86.
5. Cloherty JP, Eichenwald EC & Stark AR. Manual of Neonatal Care, 6th edn. Wolters Kluwer (India), New Delhi, 2009.
Competing interests: No competing interests
We would like to thank professor Shah for his appreciation of our work. As for ethical consideration, the results from the Chaparro et al was known when we commenced our study, but it was questioned if this was applicable in a high income country. In 2006, as part of the planning for the study, we performed a telephone survey in Sweden and concluded that 2/3 of labour departments practiced early cord clamping, including the labour department at the hospital of Halmstad, where the study was performed.
The regional ethical committee approved our study as well.
1: 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. PubMed PMID: 16782490.
Competing interests: No competing interests
Regarding Dr. Yablin's question concerning "overloading":
Delayed cord clamping has been associated with different aspects of volume overload; such as circulatory and respiratory changes and/or polycytaemia resulting in plethora. In our study, we could not see any differences between groups regarding overloading, but this was not extensively studied. We report respiratory symtoms at one and six hours after birth, packed cell volume at two days and admission to NICU.
Dr Nelle et. al published four studies on circulatory changes due to delayed cord clamping, in summary showing short term, physiologic differences in comparison to early cord clamping. (Ref 1-4)
Three different reviews of the literature have not found any serious symptoms of overload (Ref 5-7)
1: Nelle M, Kraus M, Bastert G, Linderkamp O. Effects of Leboyer childbirth on left- and right systolic time intervals in healthy term neonates. J Perinat Med. 1996;24(5):513-20. PubMed PMID: 8950732.
2: Nelle M, Zilow EP, Bastert G, Linderkamp O. Effect of Leboyer childbirth on cardiac output, cerebral and gastrointestinal blood flow velocities in full-term neonates. Am J Perinatol. 1995 May;12(3):212-6. PubMed PMID: 7612098.
3: Nelle M, Zilow EP, Kraus M, Bastert G, Linderkamp O. The effect of Leboyer delivery on blood viscosity and other hemorheologic parameters in term neonates. Am J Obstet Gynecol. 1993 Jul;169(1):189-93. PubMed PMID: 8333451.
4: Linderkamp O, Nelle M, Kraus M, Zilow EP. The effect of early and late cord-clamping on blood viscosity and other hemorheological parameters in full-term neonates. Acta Paediatr. 1992 Oct;81(10):745-50. PubMed PMID: 1421876.
5: 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. PubMed PMID: 11783688.
6: McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. Review. PubMed PMID: 18425897.
7: 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. PubMed PMID: 17374818.
Competing interests: No competing interests
I am an obstetrician in clinical practice and have long advocated immediate skin-to-skin contact between mother and baby. Unfortunately, unlike the protocol in the Swedish study, this necessitates putting the baby on the mother's abdomen which is, of course, above the level of the placenta, not 20cm. below it... Surely the same results would not obtain after 3 minutes ON the mother before cord clamping. Perhaps, as well as possible neonatal hypothermia, not to mention 3 minutes of maternal anguish, there would be a net loss of blood volume in the newborn.
Do the authors have any data under those circumstances?
Competing interests: No competing interests
Re: Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial
Dear Editor,
This is an interesting, policing guiding research paper, but I would appreciate the answers to these queries that have come to my mind:
1. If the cord was clamped earlier (like was done till now) then placental blood would squeeze into mother as it finds the way towards her (no resistance). Don't you think we should also measure the effect (in mother) of not receiving the placental blood by mother?
2. How do you know that baby was not anaemic? Mothers should have been screened for anaemia and only non-anaemic healthy mothers should have been recruited.
3. The volume of blood may cause hypervolemia in babies (fluid overload) and should have been measured too if we are measuring polycythemia and hyperbilirubinaemia as well.
Competing interests: No competing interests