Efficacy and safety of delayed cord clamping versus umbilical cord milking in term neonates

The efficacy and safety of delayed cord clamping versus umbilical cord milking in term neonates: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15174417

Enrollment

150

Registered

2016-08-29

Start date

2015-04-01

Completion date

Unknown

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile-onset iron deficiency anemia Haematological Disorders Iron deficiency anaemia, unspecified

Interventions

No previous studies are available which have compared these two interventions in term infants. In order to detect a 30% difference in mean ferritin levels between the delayed cord clamping and umbilic

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Anticipated full-term birth at GA > 37 weeks confirmed by US in first trimester or last menstrual period

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancy 2. Placenta Previa and abruption 3. Major congenital or chromosomal abnormality 4. Cord prolapse 5. Ruptured vasa previa 6. Rh sensitization 7. Fetal hydrops 8. Significant vaginal bleeding as assessed by obstetrician 24 h prior to delivery. 9. True umbilical cord knot 10. Suspected perinatal asphyxia 11. Suspected meconium aspiration 12. Fetal anomaly that required immediate resuscitation (diaphragmatic hernia) 13. Maternal infection (human immunodeficiency virus, hepatitis A, B or C) 14. Delivery in emergency room

Design outcomes

Primary

Measure	Time frame
Serum ferritin (ng/ml) at 8-12 weeks of age	—

Secondary

Measure	Time frame
1. Neonatal outcomes: 1.1. Management in delivery room (right after delivery): 1.1.1. Cord arterial and venous pH 1.1.2. Apgar score at 1 and 5 minutes 1.1.3. Need for resuscitation beyond suction and gentle simulation 1.2. Hematological values: 1.2.1. Venous Hgb value at 24 h (g/dl) 1.2.2. Venous Hct value at 24 h (%) 1.2.3. Bilirubin level at 24 h (umol/L) 1.2.4. The need for phototherapy during nursery stay 1.2.5. Maximum bilirubin level during nursery stay 1.2.6. Polycythemia defined as venous Hct > 65% during nursery stay 1.2.7. Hgb (g/dl) values at 8-12 weeks of life 1.3. Short-term outcomes (before discharge from hospital) 1.3.1. Admission to NICU 1.3.2. Respiratory distress syndrome 2. Maternal outcomes (before discharge from hospital): 2.1. Mortality 2.2. Estimated blood loss 2.3. Post-partum Hgb at 24 h 2.4. Need for blood transfusion 2.5. Need for manual removal of retained placenta 2.6. Length of the 3rd stage	—

Measure

Time frame

1. Neonatal outcomes: 1.1. Management in delivery room (right after delivery): 1.1.1. Cord arterial and venous pH 1.1.2. Apgar score at 1 and 5 minutes 1.1.3. Need for resuscitation beyond suction and gentle simulation 1.2. Hematological values: 1.2.1. Venous Hgb value at 24 h (g/dl) 1.2.2. Venous Hct value at 24 h (%) 1.2.3. Bilirubin level at 24 h (umol/L) 1.2.4. The need for phototherapy during nursery stay 1.2.5. Maximum bilirubin level during nursery stay 1.2.6. Polycythemia defined as venous Hct > 65% during nursery stay 1.2.7. Hgb (g/dl) values at 8-12 weeks of life 1.3. Short-term outcomes (before discharge from hospital) 1.3.1. Admission to NICU 1.3.2. Respiratory distress syndrome 2. Maternal outcomes (before discharge from hospital): 2.1. Mortality 2.2. Estimated blood loss 2.3. Post-partum Hgb at 24 h 2.4. Need for blood transfusion 2.5. Need for manual removal of retained placenta 2.6. Length of the 3rd stage

—

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026