CTRI/2020/02/023379已完成3 期
Resuscitation with intact versus clamped umbilical cord in late preterm and term neonates with birth asphyxia ââ?¬â?? A randomized controlled trial
Government Medical College and Hospital Chandigarh0 个研究点目标入组 162 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
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
- •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
- •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
排除标准
- •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
研究者
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