A study comparing two timings of umbilical cord clamping in healthy full term babies born by normal vaginal delivery

Physiological- Based Cord Clamping (PBCC) Versus One- Minute Delayed Cord Clamping (DCC) In Term Healthy Infants Born By Vaginal Delivery: A Randomised Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112273

Enrollment

442

Registered

2026-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

None listed

Interventions

Intervention1: Physiological Based Cord Clamping: In Intervention Group, Physiological Based Cord Clamping is done- when there is physiological separation of placenta with gush of blood and lengthenin

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term (37+0 -41+6 weeks) singleton pregnancy with anticipated delivery (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available) 2. Parents residing within 100 kilo meters of Jodhpur & consenting to follow up till first 6 months of age

Exclusion criteria

Exclusion criteria: 1. Cesarean section 2. Multiple gestation 3. Psychiatric illness or maternal drugs which may interfere or prohibits breastfeeding 4. Mothers with HIV or AIDS 5. Rh iso-immunized pregnancy with evidnec of hydrops fetalis or non immune hydrops fetalis 6. Severe fetal growth restriction (fetal weight less than third centile) 7. Any suspected or confirmed congenital anomaly or syndrome in fetus 8. Chorioamnionitis or any systemic infection in last one week before delivery After Birth 1. Infant who require resuscitation immediately after birth 2. Major Congenital abnormalities or syndromes

Design outcomes

Primary

Measure	Time frame
To compare iron status (Serum Ferritin) of term infants born by vaginal delivery undergoing physiological based cord clamping as compared to one minute delayed cord clamping at 14 weeks of ageTimepoint: Birth and 14 weeks of age	—

Secondary

Measure	Time frame
1. Neonate (Delivery room) i. To compare birth weight ii. To compare heart rate and saturation till 10 minutes of life iii. To compare time to reach 90% saturation 2. Neonate (During Hospitalisation) i. To compare haemoglobin, PCV at 12 ( 4) hours of age ii. To compare the incidence of significant hyperbilirubinemia (jaundice requiring phototherapy and/or exchange transfusion as per American Academy of Pediatrics [AAP] charts) till discharge iii. To compare incidence of respiratory support requirement due to any cause till discharge iv. To compare NICU admission till discharge Timepoint: Birth, 24 hours and 14 weeks;3. Neonate (Post Discharge) i. To compare anthropometry (weight, length and head circumference) at 14 weeks ii. To compare incidence of exclusive breastfeeding rate at 14 weeks of age iii. To compare incidence of hospitalization till 14 weeks of age iv. To compare hemoglobin, iron deficiency and iron deficiency anemia at 14 weeks of age v. To compare morbidities (diarrhea, pneumonia, seizures) till 14 weeks of age. vi. To compare Neurological outcome at 14 weeks of age using Ages and Stages Questionnaire and Bayley Scales of Infant and Toddler development 4Timepoint: 14 weeks;4. Maternal i. To compare incidence of PPH ii. To compare need for therapeutic uterotonics or surgical management or manual removal of placenta for PPH iii. To compare need of blood transfusion iv. To compare ICU admission v. To compare all cause in-hospital maternal mortality till discharge vi. To compare fall in maternal haemoglobin 24 ( 4) hours after delivery Timepoint: Birth, 24 hours	—

Measure

Time frame

1. Neonate (Delivery room) i. To compare birth weight ii. To compare heart rate and saturation till 10 minutes of life iii. To compare time to reach 90% saturation 2. Neonate (During Hospitalisation) i. To compare haemoglobin, PCV at 12 ( 4) hours of age ii. To compare the incidence of significant hyperbilirubinemia (jaundice requiring phototherapy and/or exchange transfusion as per American Academy of Pediatrics [AAP] charts) till discharge iii. To compare incidence of respiratory support requirement due to any cause till discharge iv. To compare NICU admission till discharge Timepoint: Birth, 24 hours and 14 weeks;3. Neonate (Post Discharge) i. To compare anthropometry (weight, length and head circumference) at 14 weeks ii. To compare incidence of exclusive breastfeeding rate at 14 weeks of age iii. To compare incidence of hospitalization till 14 weeks of age iv. To compare hemoglobin, iron deficiency and iron deficiency anemia at 14 weeks of age v. To compare morbidities (diarrhea, pneumonia, seizures) till 14 weeks of age. vi. To compare Neurological outcome at 14 weeks of age using Ages and Stages Questionnaire and Bayley Scales of Infant and Toddler development 4Timepoint: 14 weeks;4. Maternal i. To compare incidence of PPH ii. To compare need for therapeutic uterotonics or surgical management or manual removal of placenta for PPH iii. To compare need of blood transfusion iv. To compare ICU admission v. To compare all cause in-hospital maternal mortality till discharge vi. To compare fall in maternal haemoglobin 24 ( 4) hours after delivery Timepoint: Birth, 24 hours

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Countries

India

Contacts

Public ContactDr Neeraj Gupta

All India Institute of Medical Sciences, Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results