CTRI/2020/10/028776尚未招募3 期
Resuscitation of At Risk Term and Late Pre-term Neonates with Intact Cord vs Early Cord Clamping: A Randomized Controlled Trial - RANI
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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