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Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal.

ABSTRACT: Delayed cord clamping at birth has shown to benefit neonates with increased placental transfusion leading to higher haemoglobin concentrations, additional iron stores and less anaemia later in infancy, higher red blood cell flow to vital organs and better cardiopulmonary adaptation. As iron deficiency in infants even without anaemia has been associated with impaired development, delayed cord clamping seems to benefit full term infants also in regions with a relatively low prevalence of iron deficiency anaemia. In Nepal, there is a high anaemia prevalence among children between 6 and 17 months (72-78 %). The objective of the proposed study is to evaluate the effects of delayed and early cord clamping on anaemia (and haemoglobin level) at 8 and 12 months, ferritin at 8 and 12 months, bilirubin at 2-3 days, admission to Neonatal Intensive Care Unit (NICU) or special care nursery, and development at 12 and 18-24 months of age.A randomized, controlled trial comparing delayed and early cord clamping will be implemented at Paropakar Maternity and Women's Hospital in Kathmandu, Nepal. Pregnant woman of gestational age 34-41 weeks who deliver vaginally will be included in the study. The interventions will consist of delayed clamping of the umbilical cord (?180 s after delivery) or early clamping of the umbilical cord (?60 s). At 8 and 12 months of age, infant's iron status and developmental milestones will be measured.This trial is important to perform because, although strong indications for the beneficial effect of delayed cord clamping on anaemia at 8 to 12 months of age exist, it has not yet been evaluated by a randomized trial in this setting. The proposed study will analyse both outcome as well as safety effects. Additionally, the results may not only contribute to practice in Nepal, but also to the global community, in particular to other low-income countries with a high prevalence of iron deficiency anaemia.Clinical trial.gov NCT02222805 . Registered August 19 2014.

SUBMITTER: Kc A

PROVIDER: S-EPMC4787033 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal.

Kc Ashish A Målqvist Mats M Rana Nisha N Ranneberg Linda Jarawka LJ Andersson Ola O

BMC pediatrics 20160310

<h4>Background</h4>Delayed cord clamping at birth has shown to benefit neonates with increased placental transfusion leading to higher haemoglobin concentrations, additional iron stores and less anaemia later in infancy, higher red blood cell flow to vital organs and better cardiopulmonary adaptation. As iron deficiency in infants even without anaemia has been associated with impaired development, delayed cord clamping seems to benefit full term infants also in regions with a relatively low prev ...[more]

PMID: 26965317

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Project description:BackgroundPolicies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds after birth, whereas later cord clamping usually involves clamping the umbilical cord more than one minute after the birth or when cord pulsation has ceased. The benefits and potential harms of each policy are debated.ObjectivesTo determine the effects of early cord clamping compared with late cord clamping after birth on maternal and neonatal outcomesSearch methodsWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (13 February 2013).Selection criteriaRandomised controlled trials comparing early and late cord clamping.Data collection and analysisTwo review authors independently assessed trial eligibility and quality and extracted data.Main resultsWe included 15 trials involving a total of 3911 women and infant pairs. We judged the trials to have an overall moderate risk of bias. Maternal outcomes: No studies in this review reported on maternal death or on severe maternal morbidity. There were no significant differences between early versus late cord clamping groups for the primary outcome of severe postpartum haemorrhage (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.65 to 1.65; five trials with data for 2066 women with a late clamping event rate (LCER) of ~3.5%, I(2) 0%) or for postpartum haemorrhage of 500 mL or more (RR 1.17 95% CI 0.94 to 1.44; five trials, 2260 women with a LCER of ~12%, I(2) 0%). There were no significant differences between subgroups depending on the use of uterotonic drugs. Mean blood loss was reported in only two trials with data for 1345 women, with no significant differences seen between groups; or for maternal haemoglobin values (mean difference (MD) -0.12 g/dL; 95% CI -0.30 to 0.06, I(2) 0%) at 24 to 72 hours after the birth in three trials. Neonatal outcomes: There were no significant differences between early and late clamping for the primary outcome of neonatal mortality (RR 0.37, 95% CI 0.04 to 3.41, two trials, 381 infants with a LCER of ~1%), or for most other neonatal morbidity outcomes, such as Apgar score less than seven at five minutes or admission to the special care nursery or neonatal intensive care unit. Mean birthweight was significantly higher in the late, compared with early, cord clamping (101 g increase 95% CI 45 to 157, random-effects model, 12 trials, 3139 infants, I(2) 62%). Fewer infants in the early cord clamping group required phototherapy for jaundice than in the late cord clamping group (RR 0.62, 95% CI 0.41 to 0.96, data from seven trials, 2324 infants with a LCER of 4.36%, I(2) 0%). Haemoglobin concentration in infants at 24 to 48 hours was significantly lower in the early cord clamping group (MD -1.49 g/dL, 95% CI -1.78 to -1.21; 884 infants, I(2) 59%). This difference in haemoglobin concentration was not seen at subsequent assessments. However, improvement in iron stores appeared to persist, with infants in the early cord clamping over twice as likely to be iron deficient at three to six months compared with infants whose cord clamping was delayed (RR 2.65 95% CI 1.04 to 6.73, five trials, 1152 infants, I(2) 82%). In the only trial to report longer-term neurodevelopmental outcomes so far, no overall differences between early and late clamping were seen for Ages and Stages Questionnaire scores.Authors' conclusionsA more liberal approach to delaying clamping of the umbilical cord in healthy term infants appears to be warranted, particularly in light of growing evidence that delayed cord clamping increases early haemoglobin concentrations and iron stores in infants. Delayed cord clamping is likely to be beneficial as long as access to treatment for jaundice requiring phototherapy is available.

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.

Project description:AimTo explore delivery care staff's perceptions and attitudes towards changes in practice of umbilical cord clamping in order to identify work culture barriers and enablers for improved clinical practice and implementation of the new guidelines on cord clamping.MethodA purposive sampling strategy was used to include delivery staff at two major hospitals in Kathmandu, Nepal for focus group discussions. Key informant interviews were conducted with the ward in-charges and skilled birth attendant trainers at the respective hospitals. Data were analyzed using qualitative content analysis.ResultEight focus group discussions altogether with 34 delivery care staff working in the labor room and birthing units, and 12 key informant interviews with skilled birth attendant trainers/supervisors and ward in-charges from both hospitals participated in the study. Participants had positive attitudes towards delayed cord clamping as it was not perceived to be a difficult task and as they perceived it to be beneficial for mother and child. The "will to do good", and a high level of trust both in the hierarchical system as well as in scientific evidence were identified as promoters of change. Several barriers were mentioned, such as maternal or fetal medical conditions and physical settings, as constraints to perform delayed cord clamping. They also mentioned difficulties in adopting new guidelines due to habitual practice, lack of formal training and poor coherence within the work team. In order to bring change to the practice, participants highlighted that officially approved national and institutional protocols and regular training are crucial.ConclusionDue to poor coherence within the health system and lack of national or institutional protocols, delivery staff has to rely on their own initiative to develop skills and are left to informal decision making, and are therefore hesitant to apply new routines. In order to change cord clamping practices to align with evidence and policies health-care staff needs to be better supported by the governance structures of the health system, with clear and approved guidelines made available and coherent training and support.

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.

Dataset Information

Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal.

Publications

Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal.

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