Health Condition 1: P00-P04- Newborn affected by maternal factors and by complications of pregnancy, labor, and delivery
Conditions
Interventions
Intervention1: Intact cord resuscitation: ICR group: Neonate will be resuscitated with umbilical cord intact. Cord will be clamped after at least 180 seconds or when baby exhibits spontaneous breathin
Sponsors
Government Medical College and Hospital Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Study subjects: Neonates born at >34 weeks of gestation and requiring resuscitation at birth will be eligible for enrolment in the study. Two-step screening will be done to identify the eligible subjects. Step 1: Screening to detect fetuses at increased risk of resuscitation at birth Inclusion criteria for screening potentially eligible deliveries: Parturient women admitted in labor/delivery area of the hospital will be approached for consent if they meet following criteria: 1.Gestation at birth more than 34 weeks AND 2.Any of the following risk factors increasing the probability of need of resuscitation at birth: 1. Preeclampsia or eclampsia 2. Maternal hypertension 3. Twin pregnancy (diamniotic diachronic twins) 4. Polyhydramnios/oligohydramnios 5. Fetal macrosomia 6. Intrauterine growth restriction 7. No prenatal care 8. Emergency cesarean delivery 9. Forceps or vacuum-assisted delivery 10. Breech or other abnormal presentation 11. Category II or III fetal heart rate pattern 12. Intrapartum bleeding 13. Chorioamnionitis 14. Shoulder dystocia 15. Meconium-stained amniotic fluid Woman or her husband whose fetus is deemed to be at-risk of resuscitation at birth would be approached for consent to enroll in the study. After obtaining written informed consent, the yet to be born neonate would be randomized to one of the following study groups: 1.Intact cord resuscitation (ICR) group 2.Early cord clamping resuscitation (ECR) group Randomization will be done using a random number sequence generated using a stratified blocked randomization schedule with 1:1 allocation. Stratification will be done for mode of delivery (cesarean and vaginal). Randomization code will be enclosed in serially numbered sealed opaque envelopes which will be opened after obtaining written informed consent. Step 2: Assessing need of resuscitation and study intervention Delivery of enrolled neonates will be attended a team trained in neonatal resuscitation and led by a senior resident. Among enrolled mothers, neonates requiring resuscitation at birth will be identified as per standard resuscitation algorithm by International Liaison Committee on Resuscitation (ILCOR).8 These neonates will receive the assigned intervention as per their randomization (ICR or ECR). In both the groups resuscitation will be carried out as per standard guidelines. Neonates who do not require resuscitation will not be given study intervention (excluded) and will be managed with routine care as prescribed in ILCOR. Any additional reasons precluding application of study intervention in otherwise eligible neonates will be noted
Exclusion criteria
Exclusion criteria: Exclusion criteria for screening potentially eligible deliveries: Parturient women with any of the following criteria will not be considered for enrolment: 1. Congenital malformation or chromosomal abnormalities in fetus diagnosed in antenatal period 2. Monochorionic or Monoamniotic placentation 3. Triplets and higher order pregnancy 4. Abruption placenta or cord abnormalities 5. Invasive placentation like accrete and percreta 6. Anterior placenta previa (in case of cesarean section) 7. Fetal hydrops 8. Ruptured uterus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expanded Apgar scoreTimepoint: At 5 minutes after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Apgar scoreTimepoint: At 1 and 10 minutes after birth;Hammersmith Infant Neurological Examination (HINE) scoreTimepoint: At 3 months of corrected age.;Heart rateTimepoint: At 1, 5 and 10 minutes after birth;Maximum Thompson score during in subset of neonates developing hypoxic-ischemic encephalopathyTimepoint: First 72 h of age;Need of blood transfusion for postpartum hemorrhage in motherTimepoint: Within 72 h of delivery;Need of phototherapyTimepoint: During first 2 weeks of age;Need of surgical intervention for retained placentaTimepoint: Within 72 h of delivery;Need of various resuscitation interventions including positive pressure ventilation, intubation, chest compression and medicationsTimepoint: Till establishment of spontaneous breathing or 30 minutes of age whichever is later;PCV and bilirubinTimepoint: At 18-30 h of age;pH and base excess in blood gasTimepoint: At 60 minutes of age;Pre-ductal oxygen saturationTimepoint: At 1, 5 and 10 minutes after birth;Time to onset of regular breathingTimepoint: Till establishment of spontaneous breathing or 30 minutes of age whichever is later | — |
Countries
India
Contacts
Public ContactDr Jaspreet Singh Raina
Government Medical College and Hospital, Chandigarh
Outcome results
None listed