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Iron status at 14 weeks of age in physiological cord clamping group versus one minute based delayed cord clamping and cardiopulmonary stabilization(saturation and heart rate) immediately after birth in both the groups

Physiological versus one-minute based delayed cord clamping among term healthy Indian infants born by Elective caesarean section: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049584
Enrollment
198
Registered
2023-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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 cord clamping: In women who will be assigned to Physiological cord clamping, the cord will be clamped after the placenta is separated (when gush of the blood and placenta

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term (=37 weeks) singleton uncomplicated pregnancy with anticipated elective cesarean (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available) 2. Parents residing within 100 kilometers of Jodhpur & consenting to follow up till first 14 weeks (+4weeks) of age 3.

Exclusion criteria

Exclusion criteria: 1.Emergency caesarean section due to any reason 2.cesarean under General anesthesia due to any reason (contra-indication or procedure failure or failure of effect of spinal anesthesia) 3.Multiple gestation 4.Psychiatric illness or maternal drugs which may interfere or prohibits breastfeeding 5.Mothers with HIV or AIDS 6.Rh iso-immunized pregnancy with evidence of hydrops fetalis or non-immune hydrops fetalis 7.Severe fetal growth restriction (fetal weight 8.Any suspected or confirmed congenital anomaly or syndrome in the fetus 9.Chorioamnionitis or any systemic infection in last one week before deliver After birth 1.Infant who require resuscitation immediately after birth including supplemental oxygen or positive pressure ventilation 2.Major congenital abnormalities or syndromic infant

Design outcomes

Primary

MeasureTime frame
To compare iron status (serum ferritin) of healthy term infants born by elective cesarean and undergoing physiological-based cord clamping (PBCC-cord clamping until placental separation) as compared to infants undergoing one-minute based delayed cord clamping at 14 weeks (+4 weeks) of age.Timepoint: 98 DAYS

Secondary

MeasureTime frame
To Compare neonatal I.Birth weight APGAR score at 1,5 and 10 minutes of life & Modified APGAR score at 5 and 10 minutes II.Saturation and heart rate during first 10 minutes oF life III.PCV at 12 hours of age IV.The incidence of significant hyperbilirubinemia (jaundice requiring phototherapy and/or exchange transfusion, respiratory support requirement due to any cause & NICU admission till discharge V.Hemoglobin, incidence of iron deficiency and iron deficiency anemia at 14 weeks of age VI.Incidence of exclusive breastfeeding rate, hospitalization,Comorbidities & Anthropometry till 14 weeks of age To compare maternal I.Incidence of PPH & Need for therapeutic uterotonics or surgical management or manual removal of placenta for PPH II.Need of blood transfusion, ICU admission & All cause in-hospital maternal mortality till discharge III.Fall in maternal haemoglobin 24 hours after deliveryTimepoint: 0 days to 98 days

Countries

India

Contacts

Public ContactDR CHOUDRI MUZAFAR PASWAL

All India India Institute Of Medical Sciences, Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results

None listed

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