Oxygen Saturation at Different Time Points of Delayed Cord Clamping in Healthy Newborns

Defining Reference Range for Oxygen Saturation at Three Different Time Points of Delayed Cord Clamping in Healthy Term Neonates Born Vaginally: A Triple Arm Randomized Controlled Trial - Not available

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044546

Enrollment

750

Registered

2022-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Delayed cord clamping: This study is aimed at the evaluation of SpO2 for the first 10 minutes after birth with three different techniques of DCC i.e. cord clamping at 1, 3 minutes and a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term (Ã¢â?°Â¥37 weeks) singleton uncomplicated pregnancy with anticipated vaginal delivery (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available)

Exclusion criteria

Exclusion criteria: 1. Delivery by elective or emergency caesarean section 2. Multiple gestation 3. Confirmed congenital anomaly or syndrome in the fetus 4. Meconium stained liquor or cardiotocography abnormality or fetal distress 5. Mothers with any underlying medical or obstetric disease including i. Preeclampsia or eclampsia or chronic hypertension ii. Antepartum haemorrhage iii. Diabetes (GDM or Type I or II DM) iv. Cardiac diseases including rheumatic heart disease, congenital heart diseases and cardiomyopathy v. Chronic renal or liver disease or malignancy vi. Mothers with HIV or AIDS vii. Rh-isoimmunised pregnancy or any other blood group incompatibility viii. Need of instrumental delivery ix. Any suspected or confirmed congenital anomaly or syndrome in the fetus x. Chorioamnionitis or any systemic infection in last one week before delivery After birth 1. Any condition (eg. cord tightly around the neck) necessitating immediate cord clamping and cord cutting 2. Any condition warranting medical attention to either infant or mother or both necessitating cord cutting at that time and/or interrupting early STS in the first 10 minutes of life 3. Infant who require resuscitation immediately after birth including supplemental oxygen or positive pressure ventilation 4. Major congenital abnormalities or syndromic infant 5. Birth weight

Design outcomes

Primary

Measure	Time frame
To build percentile chart of preductal SpO2 at three different time points of DCC reflecting physiological oxygenation status of healthy term neonates born vaginally and receiving early skin-to-skin contact. Timepoint: First 10 minute of life (continuous data recording)	—

Secondary

Measure	Time frame
.Timepoint: .	—

Countries

India

Contacts

Public ContactDR ANIL KUMAR B N

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

neerajpgi@yahoo.co.in8003996908

Outcome results