Effect of Delayed Cord Clamping on Neurodevelopment at 3 Years: A Randomized Controlled Trial.
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ABSTRACT: Introduction
Iron deficiency (ID) is associated with poor neurodevelopment. We have previously shown that delayed umbilical cord clamping (CC) improves iron stores at 8 months and neurodevelopment at 1 year in term, healthy infants in Nepal.Objective
The aim of this study was to assess the effects of delayed CC (≥180 s) compared to early CC (≤60 s) on neurodevelopment using the Ages and Stages Questionnaire (ASQ) at age 3 years.Methods
In 2014, 540 healthy Nepalese infants born at term were randomized in a 1:1 ratio to delayed or early CC. At 3 years of age, ASQ assessment was performed by phone interviews with parents. A score >1 standard deviation below the mean was defined as "at risk" for developmental impairment.Results
At 3 years of age, 350 children were followed up, 170 (63.0%) in the early CC group and 180 (66.7%) in the delayed CC group. No significant differences in ASQ scores in any domains between groups were found. However, more girls were "at risk" for affected gross motor development in the early CC group: 14 (18.9%) versus 6 (6.3%), p = 0.02.Conclusion
There were no significant differences in ASQ scores in any domains between groups. In the subgroup analysis, fewer girls who underwent delayed CC were "at risk" for delayed gross motor development. Due to the pronounced difference in iron stores at 8 months postpartum in this cohort, follow-up studies at an older age are motivated since neurodevelopmental impairment after early ID may be more detectable with increasing age.
SUBMITTER: Berg JHM
PROVIDER: S-EPMC8491483 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo evaluate whether placental transfusion influences brain myelination at 4 months of age.Study designA partially blinded, randomized controlled trial was conducted at a level III maternity hospital in the US. Seventy-three healthy term pregnant women and their singleton fetuses were randomized to either delayed umbilical cord clamping (DCC, >5 minutes) or immediate clamping (ICC, <20 seconds). At 4 months of age, blood was drawn for ferritin levels. Neurodevelopmental testing (Mullen Scales of Early Learning) was administered, and brain myelin content was measured with magnetic resonance imaging. Correlations between myelin content and ferritin levels and group-wise DCC vs ICC brain myelin content were completed.ResultsIn the DCC and ICC groups, clamping time was 172 ± 188 seconds vs 28 ± 76 seconds (P < .002), respectively; the 48-hour hematocrit was 57.6% vs 53.1% (P < .01). At 4 months, infants with DCC had significantly greater ferritin levels (96.4 vs 65.3 ng/dL, P = .03). There was a positive relationship between ferritin and myelin content. Infants randomized to the DCC group had greater myelin content in the internal capsule and other early maturing brain regions associated with motor, visual, and sensory processing/function. No differences were seen between groups in the Mullen testing.ConclusionAt 4 months, infants born at term receiving DCC had greater ferritin levels and increased brain myelin in areas important for early life functional development. Endowment of iron-rich red blood cells obtained through DCC may offer a longitudinal advantage for early white matter development.Trial registrationClinicalTrials.gov: NCT01620008.
| S-EPMC6259583 | biostudies-literature
Project description:BackgroundDelayed cord clamping (DCC) is a placental to new-born transfusion strategy recommended by obstetric and gynaecological societies. Though not widely adopted, umbilical cord milking (UCM) may achieve faster transfusion when DCC cannot be performed such as when a neonate requires resuscitation.MethodsPragmatic, two-arm, randomized clinical trial in which consenting women in spontaneous labour or provider-initiated delivery at 28 to less than 37 weeks at Kenyatta National Hospital in Nairobi, Kenya, were enrolled. At delivery, stable preterm infants were randomized to UCM (4 times) or DCC (60 seconds). Neonatal samples were collected for analysis at 24 hours after delivery. Maternal primary PPH (within 24 hours) and neonatal jaundice (within 1 week) were evaluated clinically. The primary outcome was the mean neonatal haemoglobin level at 24 hours after birth. Modified Intention to treat analysis was used for all outcomes. P-value was significant at p<0.05.ResultsBetween March 2018 to March 2019, 344 pregnant women underwent screening, and 280 eligible participants were randomized when delivery was imminent. The intervention was not performed on 19 ineligible neonates. Of the remaining 260 neonates, 133 underwent UCM while 128 underwent DCC. Maternal and neonatal baseline characteristics were similar. The mean neonatal haemoglobin (17.1 vs 17.5 grams per decilitre, p = 0.191), haematocrit (49.6% vs 50.3%, p = 0.362), anaemia (9.8% vs 11.7%, p = 0.627), maternal PPH (2.3% vs 3.1%, p = 0.719) were similar between UCM and DCC respectfully. However, neonatal polycythaemia (2.3% vs 8.6%, p = 0.024) and neonatal jaundice (6.8% vs 15.6%, p = 0.024) were statistically significantly lower in UCM compared to DCC.ConclusionUCM compared to DCC for preterm neonates resulted in similar outcomes for neonatal haemoglobin, haematocrit, anaemia and maternal primary PPH and a lower proportion of neonatal polycythaemia and clinical jaundice. UCM offers a comparable method of placental transfusion compared to DCC and may be considered as an alternative to DCC in preterm neonates at 28 to <37 weeks' gestation.
| S-EPMC7837492 | biostudies-literature
Project description:ObjectiveTo compare maternal blood loss with immediate cord clamping versus delayed cord clamping in women undergoing spontaneous vaginal delivery at term.MethodsParallel group non-blinded randomized trial conducted at a single center in Italy. Women with singleton gestations who underwent spontaneous vaginal delivery at term were eligible and were randomized in a 1:1 ratio to either immediate or delayed cord clamping. In the immediate cord clamping group, cord clamping was within 15 s after birth. In the delayed cord clamping group, cord clamping was after more than 60 s, or when the cord had stopped pulsing. The primary outcome was change in maternal hemoglobin level from the day of delivery to day one after delivery.ResultsA total of 122 participants were enrolled in the trial. There were no significant differences in maternal blood loss as assessed by comparing the decrease in maternal hemoglobin level (mean difference - 0.10 g/dl, 95% confidence interval - 0.28 to 0.08) between the two groups. The mean hemoglobin level at postdelivery day 1 was 11.0 ± 1.5 g/dl in the delayed group and 11.3 ± 1.6 g/dl in the immediate group.ConclusionsDelayed umbilical cord clamping, compared with immediate umbilical cord clamping, resulted in no significant change in maternal hemoglobin level 1 day after delivery.Trial registrationClinicaltrials.gov NCT04353544.
| S-EPMC9790594 | biostudies-literature
Project description:PurposeTo evaluate the effect of intravenous infusion versus intramyometrial injection of oxytocin on hemoglobin levels in neonates with delayed umbilical cord clamping during cesarean section.MethodsThe multi-centre randomized controlled trial was performed at three hospitals from February to June 2023. Women with term singleton gestations scheduled for cesarean delivery were allocated to receive an intravenous infusion of 10 units of oxytocin or a myometrial injection of 10 units of oxytocin during the surgery. The primary outcome was neonatal hemoglobin at 48 to 96 h after birth. Secondary outcomes were side-effects of oxytocin, postpartum haemorrhage, phototherapy for jaundice, feeding at 1 month, maternal and neonatal morbidity and re-admissions.ResultsA total of 360 women were randomized (180 women in each group). The mean neonatal hemoglobin did not show a significant difference between the intravenous infusion group (194.3 ± 21.7 g/L) and the intramyometrial groups (195.2 ± 24.3 g/L) (p = 0.715). Secondary neonatal outcomes, involving phototherapy for jaundice, feeding at 1 month and neonatal intensive care unit admission were similar between the two groups. The maternal outcomes did not differ significantly between the two groups, except for a 200 mL higher intraoperative infusion volume observed in the intravenous group compared to the intramyometrial group.ConclusionAmong women undergoing elective cesarean delivery of term singleton pregnancies, there was no significant difference in neonatal hemoglobin at 48 to 96 h after birth between infants with delayed cord clamping, whether the oxytocin was administrated by intravenous infusion or intramyometrial injection.Trial registrationChinese Clinical trial registry: ChiCTR2300067953 (1 February 2023).
| S-EPMC11258157 | biostudies-literature
Project description:ObjectiveThis study aims to assess delayed versus early umbilical cord clamping in preeclamptic mothers undergoing scheduled caesarean delivery regarding the maternal intra-operative blood loss and neonatal outcomes.MethodsA clinical trial was conducted on 62 near-term preeclamptic mothers (36-38+6 weeks) who were planned for caesarean delivery. They were randomly assigned into two groups. The first group was the early cord clamping (ECC) group (n= 31), in which clamping the umbilical cord was within 15 seconds, while the second group was the delayed cord clamping (DCC) group (n= 31), in which clamping the umbilical cord was at 60 seconds. All patients were assessed for intra-operative blood loss and incidence of primary postpartum haemorrhage (PPH). Otherwise, all neonates were assessed for APGAR scores, the need for the neonatal intensive care unit (NICU) admission due to jaundice, and blood tests (haemoglobin, haematocrit. and serum bilirubin).ResultsThere was not any significant difference between the two groups regarding the maternal estimated blood loss (P=0.673), the rates of PPH (P=0.1), post-delivery haemoglobin (P=0.154), and haematocrit values (P=0.092). Neonatal outcomes also were showing no significant difference regarding APGAR scores at the first minute (P=1) and after 5 minutes (P=0.114), day 1 serum bilirubin (P=0.561), day 3 serum bilirubin (P=0.676), and the rate of NICU admission (P=0.671). However, haemoglobin and haematocrit values were significantly higher in the DCC group than in the ECC group (P<0.001).ConclusionThere is no significant difference between DCC and ECC regarding maternal blood loss. However, DCC has the advantage of significantly higher neonatal haemoglobin.Trial registrationIt was first registered at ClinicalTrials.gov on 10/12/2019 with registration number NCT04193345.
| S-EPMC9233844 | biostudies-literature
Project description:ImportanceThe American College of Obstetricians and Gynecologists recommends a delay in umbilical cord clamping in term neonates for at least 30 to 60 seconds after birth. Most literature supporting this practice is from low-risk vaginal deliveries. There are no published data specific to cesarean delivery.ObjectiveTo compare maternal blood loss with immediate cord clamping vs delayed cord clamping in scheduled cesarean deliveries at term (≥37 weeks).Design, setting, and participantsRandomized clinical trial performed at 2 hospitals within a tertiary academic medical center in New York City from October 2017 to February 2018 (follow-up completed March 15, 2018). A total of 113 women undergoing scheduled cesarean delivery of term singleton gestations were included.InterventionsIn the immediate cord clamping group (n = 56), cord clamping was within 15 seconds after birth. In the delayed cord clamping group (n = 57), cord clamping was at 60 seconds after birth.Main outcomes and measuresThe primary outcome was change in maternal hemoglobin level from preoperative to postoperative day 1, which was used as a proxy for maternal blood loss. Secondary outcomes included neonatal hemoglobin level at 24 to 72 hours of life.ResultsAll of the 113 women who were randomized (mean [SD] age, 32.6 [5.2] years) completed the trial. The mean preoperative hemoglobin level was 12.0 g/dL in the delayed and 11.6 g/dL in the immediate cord clamping group. The mean postoperative day 1 hemoglobin level was 10.1 g/dL in the delayed group and 9.8 g/dL in the immediate group. There was no significant difference in the primary outcome, with a mean hemoglobin change of -1.90 g/dL (95% CI, -2.14 to -1.66) and -1.78 g/dL (95% CI, -2.03 to -1.54) in the delayed and immediate cord clamping groups, respectively (mean difference, 0.12 g/dL [95% CI, -0.22 to 0.46]; P = .49). Of 19 prespecified secondary outcomes analyzed, 15 showed no significant difference. The mean neonatal hemoglobin level, available for 90 neonates (79.6%), was significantly higher with delayed (18.1 g/dL [95% CI, 17.4 to 18.8]) compared with immediate (16.4 g/dL [95% CI, 15.9 to 17.0]) cord clamping (mean difference, 1.67 g/dL [95% CI, 0.75 to 2.59]; P < .001). There was 1 unplanned hysterectomy in each group.Conclusions and relevanceAmong women undergoing scheduled cesarean delivery of term singleton pregnancies, delayed umbilical cord clamping, compared with immediate cord clamping, resulted in no significant difference in the change in maternal hemoglobin level at postoperative day 1.Trial registrationClinicalTrials.gov Identifier: NCT03150641.
| S-EPMC6865311 | biostudies-literature
Project description:ObjectiveThe objective of the study was to measure the effects of a 5-min delay (DCC) versus immediate cord clamping (ICC) on residual placental blood volume (RPBV) at birth, and hemoglobin and serum bilirubin at 24 to 48 h of age.Study designIn this prospective randomized controlled trial, 73 women with term (37 to 41 weeks) singleton fetuses were randomized to DCC (⩾5 min; n=37) or ICC (<20 s; n=36).ResultsMaternal and infant demographics were not different between the groups. Mean cord clamping time was 303±121 (DCC) versus 23±59 (ICC) s (P<0.001) with 10 protocol violations. Cord milking was the proxy for DCC (n=11) when the provider could not wait. Infants randomized to DCC compared with ICC had significantly less RPBV (20.0 versus 30.8 ml kg-1, P<0.001), higher hemoglobin levels (19.4 versus 17.8 g dl-1, P=0.002) at 24 to 48 h, with no difference in bilirubin levels.ConclusionTerm infants had early hematological advantage of DCC without increases in hyperbilirubinemia or symptomatic polycythemia.
| S-EPMC5334141 | biostudies-literature
Project description:ObjectiveTo investigate the effects of delayed umbilical cord clamping, compared with early clamping, on infant iron status at 4 months of age in a European setting.DesignRandomised controlled trial.SettingSwedish county hospital.Participants400 full term infants born after a low risk pregnancy.InterventionInfants were randomised to delayed umbilical cord clamping (≥ 180 seconds after delivery) or early clamping (≤ 10 seconds after delivery).Main outcome measuresHaemoglobin and iron status at 4 months of age with the power estimate based on serum ferritin levels. Secondary outcomes included neonatal anaemia, early respiratory symptoms, polycythaemia, and need for phototherapy.ResultsAt 4 months of age, infants showed no significant differences in haemoglobin concentration between the groups, but infants subjected to delayed cord clamping had 45% (95% confidence interval 23% to 71%) higher mean ferritin concentration (117 μg/L v 81 μg/L, P < 0.001) and a lower prevalence of iron deficiency (1 (0.6%) v 10 (5.7%), P = 0.01, relative risk reduction 0.90; number needed to treat = 20 (17 to 67)). As for secondary outcomes, the delayed cord clamping group had lower prevalence of neonatal anaemia at 2 days of age (2 (1.2%) v 10 (6.3%), P = 0.02, relative risk reduction 0.80, number needed to treat 20 (15 to 111)). There were no significant differences between groups in postnatal respiratory symptoms, polycythaemia, or hyperbilirubinaemia requiring phototherapy.ConclusionsDelayed cord clamping, compared with early clamping, resulted in improved iron status and reduced prevalence of iron deficiency at 4 months of age, and reduced prevalence of neonatal anaemia, without demonstrable adverse effects. As iron deficiency in infants even without anaemia has been associated with impaired development, delayed cord clamping seems to benefit full term infants even in regions with a relatively low prevalence of iron deficiency anaemia. Trial registration Clinical Trials NCT01245296.
| S-EPMC3217058 | biostudies-literature
Project description:BACKGROUND:Delayed umbilical cord clamping is associated with greater haemoglobin concentration and iron storage between 3 and 6?months of life and with less need of blood transfusion and lower incidence of neonatal hypotension compared to early umbilical cord clamping. METHODS:The aim was to test the hypothesis that delayed cord clamping is better than early cord clamping in term infants born by elective caesarean section. Group A was subjected to immediate cord clamping while in the Group B, the umbilical cord was clamped 1?min after birth. Primary aim was revealed the difference in pre-ductal saturation between two groups while secondary aim was investigating the difference in HR, Ht, bilirubin and glycaemia. Pre-ductal SpO2 and HR were recorded at 5 and 10?min after birth, T was analysed 10?min after birth, glycaemia was revealed at 120?min while Ht and bilirubin were collected at 72?h. RESULTS:132 newborns were enrolled in the study and allocated in ratio 1:1 to group A or B. Delayed cord clamping did not improve SpO2, HR and T values compared to immediate cord clamping (p?>?0,05). However, Group B showed greater haematocrit and bilirubin values at 72?h compared to Group A (56,71 ±?6663 vs 51,56 ±?6929; p?<?0,05 and 8,54 ±?2,90 vs 7,06 ±?2,76; p?<?0,05). Glycaemia value did not differ between two groups (p?>?0,05). CONCLUSIONS:Group B did not reveal any differences in SpO2, HR, T and glycaemia compared to Group A. Group B showed greater values of haematocrit and bilirubin but without need of phototherapy. TRIAL REGISTRATION:Umbilical Cord Clamping: What Are the Benefits; NCT03878602. Registered 18 March 2019 retrospectively registered.
| S-EPMC7247269 | biostudies-literature
Project description:Background: Recently, the literature suggested that placental transfusion facilitated by delayed cord clamping (DCC), besides having benefits on hematological parameters, might improve the infants' brain development. Objective: The present review primarily evaluates the Ages and Stages Questionnaire (ASQ) total score mean difference (MD) at long-term follow-up (≥4 months) comparing DCC (>90 or >180 s) to early cord clamping (ECC). Secondary aims consisted of evaluating the ASQ domains' MD and the results obtained from other methods adopted to evaluate the infants' neurodevelopment. Methods: MEDLINE, Scopus, Cochrane, and ClinicalTrials.gov databases were searched (up to 2nd November 2020) for systematic review and meta-analysis. All randomized controlled trials (RCTs) of term singleton gestations received DCC or ECC. Multiple pregnancies, pre-term delivery, non-randomized studies, and articles in languages other than English were excluded. The included studies were assessed for bias and quality. ASQ data were pooled stratified by time to follow up. Results: This meta-analysis of 4 articles from 3 RCTs includes 765 infants with four-month follow-up and 672 with 12 months follow-up. Primary aim (ASQ total score) pooled analysis was possible only for 12 months follow-up, and no differences were found between DCC and ECC (MD 1.1; CI 95: -5.1; 7.3). DCC approach significantly improves infants' communication domains (MD 0.6; CI 95: 0.1; 1.1) and personal-social assessed (MD 1.0; CI 95: 0.3; 1.6) through ASQ at 12 months follow-up. Surprisingly, the four-month ASQ personal social domain (MD -1.6; CI 95: -2.8; -0.4) seems to be significantly lower in the DCC group than in the ECC group. Conclusions: DCC, a simple, non-interventional, and cost-effective approach, might improve the long-term infants' neurological outcome. Single-blinding and limited studies number were the main limitations. Further research should be performed to confirm these observations, ideally with RCTs adopting standard methods to assess infants' neurodevelopment. Trial registration: NCT01245296, NCT01581489, NCT02222805, NCT01620008, IRCT201702066807N19, and NCT02727517.
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