Reviving babies who donâ??t cry at birth, without cutting the cord

Phase 3

• Conditions: Health Condition 1: P00-P96- Certain conditions originating in the perinatal period

• Registration Number: CTRI/2020/10/028776
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

Late Preterm and term neonates (>=34 0/7 weeks of gestation onwards) at risk for resuscitation. These will include pregnancies with the following complications

1.Fetal heart rate (HR) tracing showing Category II or III CTG findings as per ACOG guidelines or Pathological or Suspicious as per NICE guidelines. Category I, which is suggestive of a normal CTG, will not be included.

2.Pathological or Suspicious CTG as per NICE 2014 guidelines

3.Shoulder dystocia, Fetal macrosomia

4.Fetal malpresentation ( breech, shoulder, face and brow presentation, sinciput presentation and asynclitism) and malposition (occipito-posterior and occipito-transverse)

5.Obstructed Labour

6.Vacuum- or forceps-assisted vaginal delivery

7.Meconium-stained amniotic fluid

8.Chronic hypertension and Preeclampsia or eclampsia

9.Twin (diamniotic diachronic twins) In this case, only the second foetus will be randomised for the study. The first twin will not be part of the study and will receive the standard of care.

10.Polyhydramnios/oligohydramnios

11.Fetal Growth Restriction

12.Chorioamnionitis

13.Intra-partum Bleeding

14.Severe Maternal Anemia at the time of delivery

Exclusion Criteria

1.Antenatally detected life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation)

2.Suspected severe fetal anemia

3.Mono-chorionic or mono-amniotic twins

4.Three or greater order in multiple gestation

5.Decision made for comfort care only

6.Complete placental abruption, Placenta Previa

7.Bad Obstetric History (Recurrent Pregnancy Loss) as per RCOG definition

8.Use of Assisted Reproductive Technology like In Vitro Fertilization

9.Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified