Health Condition 1: O76- Abnormality in fetal heart rate and rhythm complicating labor and delivery Health Condition 2: O68- Labor and delivery complicated byabnormality of fetal acid-base balance
Conditions
Interventions
Intervention1: INTACT CORD RESUSCITATION TILL PLACENTAL DELIVERY: In this group, newborns who require resuscitation at birth will be managed while the umbilical cord remains intact and attached to the
Sponsors
SNCU and NICU Complex Department of Pediatrics Medical College and Hospital Kolkata
Eligibility
Inclusion criteria
Inclusion criteria: Neonates will be eligible for inclusion in the study if all of the following criteria are met. The gestational age must be more than 34 weeks, including late preterm and term neonates, confirmed by early ultrasound or last menstrual period with clinical correlation. The place of birth must be the study center, either by vaginal or cesarean delivery. Eligible neonates must be identified antenatally or intrapartum as being at risk for requiring resuscitation at birth, based on clinical indicators. These include abnormal or non-reassuring fetal heart rate patterns as defined by ACOG Category two or three, or suspicious or pathological CTG as per NICE 2014 criteria; labor or delivery complications such as shoulder dystocia, fetal macrosomia, obstructed labor, assisted vaginal delivery, malpresentation or malposition; amniotic fluid or placental issues like meconium-stained fluid, polyhydramnios, oligohydramnios, chorioamnionitis, or intrapartum bleeding; maternal medical or obstetric conditions including chronic hypertension, preeclampsia, eclampsia, severe maternal anemia at delivery, and twin pregnancy where only the second twin in diamniotic-dichorionic gestations is eligible for randomization; and fetal growth issues such as antenatally diagnosed fetal growth restriction. In addition, neonates must require resuscitation at birth, defined as not crying or having inadequate respiratory effort within the first 30 seconds of life, as determined by the neonatal team. Only live-born infants with a detectable heart rate at birth will be included. Both singleton pregnancies and the second twin in diamniotic dichorionic twins are eligible. Written informed consent from parents or legal guardians is mandatory, either obtained antenatally in identified high risk cases or postnatally through deferred consent where prior consent is not feasible, in accordance with ethical approval.
Exclusion criteria
Exclusion criteria: Neonates will be excluded from the study if any of the following criteria are present. These include gestational age less than 34 weeks, stillbirth, or absence of a detectable heart rate at birth. Multiple gestations will be excluded except for the second twin in diamniotic dichorionic twin pregnancies; monoamniotic, monochorionic twins, or higher order multiples are ineligible. Congenital or antenatal fetal conditions that preclude inclusion include antenatally diagnosed life threatening anomalies such as severe hydrops fetalis, lethal chromosomal abnormalities, major malformations incompatible with life, suspected or confirmed severe fetal anemia, and a bad obstetric history as per RCOG guidelines, including three or more consecutive spontaneous miscarriages, previous unexplained intrauterine fetal deaths, or prior neonatal deaths of unclear cause. Maternal and obstetric exclusions include complete placental abruption, placenta previa with hemorrhagic risk, severe maternal anemia needing urgent delivery intervention, symptomatic chorioamnionitis with maternal or fetal instability, symptomatic COVID 19 infection requiring oxygen or ICU care, intrapartum bleeding requiring urgent intervention, maternal seropositivity for HIV, hepatitis B or C, and use of assisted reproductive technologies like IVF due to altered placental or neonatal physiology. Delivery related exclusions comprise any short or compromised umbilical cord scenario such as cord prolapse, avulsion, knot, or very short cord that impedes safe bedside resuscitation, as well as instrumental delivery resulting in neonatal head trauma that precludes intact cord handling. Cases where comfort care is the planned approach or anticipated neonatal demise is expected are also excluded. Finally, parental refusal to consent or any concern raised by the attending obstetrician or neonatologist regarding safety or appropriateness of the intervention at the time of delivery will result in exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the incidence of the composite outcome of neonatal mortality or moderate-to-severe hypoxic-ischemic encephalopathy, defined according to Sarnat and Sarnat staging, between neonates undergoing resuscitation with the umbilical cord left intact until placental delivery and those receiving resuscitation after conventional cord clamping.Timepoint: Within the first seven days of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: nil | — |
Countries
India
Contacts
Public ContactDr Sourav Nandi
Medical College and Hospital, Kolkata
Outcome results
None listed