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

Phase 3

• Registration Number: CTRI/2022/08/044546
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Term (�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

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 <2000 grams

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>Timepoint: First 10minuteof life (continuous data recording)

Secondary Outcome Measures

Name	Time	Method
.Timepoint: .