A randomized controlled clinical trial on peripartum effects of delayed versus immediate umbilical cord clamping on term newborns

Ofojebe, Chukwuemeka Jude; Eleje, George Uchenna; Ikechebelu, Joseph Ifeanyichukwu; Okpala, Boniface Chukwuneme; Ofojebe, Binyelum Adaobi; Ugwu, Emmanuel Onyebuchi; Igbodike, Emeka Philip; Onwuegbuna, Arinze Anthony; Ikwuka, David Chibuike; Ejikeme, Toochukwu Benjamin

doi:10.1016/j.ejogrb.2021.04.038

Cited by 11 publications

(16 citation statements)

References 21 publications

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“…We demonstrated feasibility of a simple, low-cost strategy of intact cord resuscitation at both cesarean and vaginal births with engagement of medical, midwifery, and theatre staff. In our small sample size, we found no difference in the risk of postpartum haemorrhage between PBCC and ECC, similar to other recent studies [23,24]. The proportion of mothers having postpartum haemorrhage in the trial was high, likely reflecting the high-risk births recruited to the trial.…”

Section: Discussionsupporting

confidence: 90%

Physiologically based cord clamping for infants ≥32+0 weeks gestation: A randomised clinical trial and reference percentiles for heart rate and oxygen saturation for infants ≥35+0 weeks gestation

et al. 2022

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Background Globally, the majority of newborns requiring resuscitation at birth are full term or late-preterm infants. These infants typically have their umbilical cord clamped early (ECC) before moving to a resuscitation platform, losing the potential support of the placental circulation. Physiologically based cord clamping (PBCC) is clamping the umbilical cord after establishing lung aeration and holds promise as a readily available means of improving early newborn outcomes. In mechanically ventilated lambs, PBCC improved cardiovascular stability and reduced hypoxia. We hypothesised that PBCC compared to ECC would result in higher heart rate (HR) in infants needing resuscitation, without compromising safety. Methods and findings Between 4 July 2018 and 18 May 2021, infants born at ≥32+0 weeks’ gestation with a paediatrician called to attend were enrolled in a parallel-arm randomised trial at 2 Australian perinatal centres. Following initial stimulation, infants requiring further resuscitation were randomised within 60 seconds of birth using a smartphone-accessible web link. The intervention (PBCC) was to establish lung aeration, either via positive pressure ventilation (PPV) or effective spontaneous breathing, prior to cord clamping. The comparator was early cord clamping (ECC) prior to resuscitation. The primary outcome was mean HR between 60 to 120 seconds after birth, measured using 3-lead electrocardiogram, extracted from video recordings blinded to group allocation. Nonrandomised infants had deferred cord clamping (DCC) ≥120 seconds in the observational study arm. Among 508 at-risk infants enrolled, 123 were randomised (n = 63 to PBCC, n = 60 to ECC). Median (interquartile range, IQR) for gestational age was 39.9 (38.3 to 40.7) weeks in PBCC infants and 39.6 (38.4 to 40.4) weeks in ECC infants. Approximately 49% and 50% of the PBCC and ECC infants were female, respectively. Five infants (PBCC = 2, ECC = 3, 4% total) had missing primary outcome data. Cord clamping occurred at a median (IQR) of 136 (126 to 150) seconds in the PBCC arm and 37 (27 to 51) seconds in the ECC arm. Mean HR between 60 to 120 seconds after birth was 154 bpm (beats per minute) for PBCC versus 158 bpm for ECC (adjusted mean difference −6 bpm, 95% confidence interval (CI) −17 to 5 bpm, P = 0.39). Among 31 secondary outcomes, postpartum haemorrhage ≥500 ml occurred in 34% and 32% of mothers in the PBCC and ECC arms, respectively. Two hundred ninety-five nonrandomised infants (55% female) with median (IQR) gestational age of 39.6 (38.6 to 40.6) weeks received DCC. Data from these infants was used to create percentile charts of expected HR and oxygen saturation in vigorous infants receiving DCC. The trial was limited by the small number of infants requiring prolonged or advanced resuscitation. PBCC may provide other important benefits we did not measure, including improved maternal–infant bonding and higher iron stores. Conclusions In this study, we observed that PBCC resulted in similar mean HR compared to infants receiving ECC. The findings suggest that for infants ≥32+0 weeks’ gestation who receive brief, effective resuscitation at closely monitored births, PBCC does not provide additional benefit over ECC (performed after initial drying and stimulation) in terms of key physiological markers of transition. PBCC was feasible using a simple, low-cost strategy at both cesarean and vaginal births. The percentile charts of HR and oxygen saturation may guide clinicians monitoring the transition of at-risk infants who receive DCC. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000621213.

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Section: Discussionsupporting

confidence: 90%

Physiologically based cord clamping for infants ≥32+0 weeks gestation: A randomised clinical trial and reference percentiles for heart rate and oxygen saturation for infants ≥35+0 weeks gestation

et al. 2022

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“…In both the studies the mean maternal age was similar to our studies. 10 In this study the maximum number of patients delivered at 39-40 weeks period of gestation the mean gestational age at delivery being 38.59 weeks ± 1.05 in the DCC group and maximum number of patients were delivered at 38-39 weeks in the ECC group and the mean gestational age being 38.68 weeks ± 1.18 in the ECC group (p = 0.736) which was statistically insignificant.…”

Section: Discussionmentioning

confidence: 54%

“…This finding is similar to other 12,13 . Mean infant hemoglobin at 48hr after birth was 16.51±1.71 and 15.16±2.27 gm% respectively(p<0.001) 10 .…”

Section: Discussionmentioning

confidence: 91%

Effect of Early versus Delayed Cord Clamping on Hematological Parameters of Term Neonates

Ravishankar

Das

Dalal

et al. 2022

Indones J Obstet Gynecol

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Objectives : To compare the serum bilirubin, hemoglobin, and hematocrit in term infants undergoing delayed cord clamping with early cord clamping after normal and caesarean delivery.Methods : This is a prospective observational study. The neonates in which cord clamping was done within 15 seconds were considered in early cord clamping (ECC) group and where cord clamping was done after 1 minute was considered in delayed cord clamping (DCC) group. The PCV, Hb, serum bilirubin were observed after 48 hours in both the groups and compared.Results : There was statistically significant difference in means of Hb level (p = 0.001) and PCV level (p = 0.001) between DCC and ECC group whereas no statistically significant difference was present in total serum bilirubin level (p = 0.359).Conclusion: There was no significant increase in risk of polycythaemia and hyperbilirubinemia between delayed cord clamping and early cord clamping group rather has beneficial effects in increasing the haemoglobin and haematocrit in the infants.Keywords : delayed cord clamping, early cord clamping, hematocrit, hemoglobin, serum bilirubin, hyperbilirubinemia. Abstrak Tujuan: Untuk membandingkan bilirubin serum, hemoglobin, dan hematoklit pada bayi aterm yang dilakukan delayed cord clamping dan early cord clamping setelah persalinan normal dan seksio sesarea.Metode: Studi ini merupakan studi prospektif. Neonatus yang dilakukan cord clamping dalam 15 detik dikelompokkan pada delayed cord clamping (DCC). PCV, Hb, bilirubin serum diobservasi dalam 48 jam pada kedua kelompok, kemudian dibandingkan.Hasil: Terdapat perbedaan signifikan antara kadar Hb (p = 0,001) dan PCV (p = 0,0010 antara kelompok DCC dan ECC, sedangkan tidak terdapat perbedaan signifikan pada kadar bilirubin serum total (p = 0,3590Kesimpulan: Tidak terdapat peningkatan signifikan polisitemia dan hyperbilirubinemia antara DCC dan ECC.Kata kunci: delayed cord clamping, early cord clapming, hematokrit, hemoglobin, serum bilirubin, hyperbilirubinemia

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“…LCC also transports excess red blood cells into the infant, which, combined with the limited ability of the newborn liver to metabolize bilirubin, theoretically makes newborns more susceptible to jaundice. Nevertheless, many researchers have reported no signi cant differences in bilirubin levels and phototherapy rates in infants receiving LCC, compared with neonates receiving ICC [7,9,16,17]. These studies focus on normal pregnant women or those without clear de nitions.…”

Section: Discussionmentioning

confidence: 99%

Differential Effects of Later Cord Clamping on Bilirubin Levels in Normal and Diabetic Pregnancies

Pan

Lan

et al. 2022

Preprint

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Purpose: To investigate the effect of later cord clamping on bilirubin levels and phototherapy rates in normal pregnancy term neonates and diabetic pregnancy neonates.Methods: This is a prospective study that enrolled pregnant women without pregnancy complications and those with diabetes according to the criteria. The subjects were randomized in a 1:1 ratio to either immediate cord clamping or later cord clamping. The final data analysis involved 132 cases of diabetic pregnancy and 129 cases of normal pregnancy. The main outcomes were neonatal the transcutaneous bilirubin values in 2-4 days postpartum and the phototherapy rate.Results: In diabetic pregnancy, neonatal bilirubin levels on the 2-4 day postpartum and phototherapy rates were significantly higher in later cord clamping group than in immediate cord clamping group, while in normal pregnancy, there was no statistical difference in bilirubin values and phototherapy rates between different clamping methods. After receiving later cord clamping, bilirubin levels on the third postnatal day and the rate of neonates needing phototherapy were higher in the diabetic pregnancy group than in the normal pregnancy group.Conclusions: Later cord clamping increases the risk of jaundice in newborns whose mothers have diabetes, but has no effect on newborns with normal pregnancy.Trial registration: ClinicalTrials.gov: NCT04369313; date of registration: April 27, 2020 (retrospectively registered)

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A randomized controlled clinical trial on peripartum effects of delayed versus immediate umbilical cord clamping on term newborns

Cited by 11 publications

References 21 publications

Physiologically based cord clamping for infants ≥32+0 weeks gestation: A randomised clinical trial and reference percentiles for heart rate and oxygen saturation for infants ≥35+0 weeks gestation

Physiologically based cord clamping for infants ≥32+0 weeks gestation: A randomised clinical trial and reference percentiles for heart rate and oxygen saturation for infants ≥35+0 weeks gestation

Effect of Early versus Delayed Cord Clamping on Hematological Parameters of Term Neonates

Differential Effects of Later Cord Clamping on Bilirubin Levels in Normal and Diabetic Pregnancies

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