Physiological versus one minute based delayed cord clamping among late preterm infants not requiring resuscitation a randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Primary outcome:
研究概览
简要总结
Delayed cord clamping (DCC) is the standard of care among healthy infants after birth due to various benefits. Ideal timing of DCC is not known and varies from 30-60 seconds (AAP) till placental delivery. We hypothesise that this timing of clamping the cord should be left upon the mother-infant dyad and should not be time-based. This is because the placental transfusion takes place till the placenta separates. Therefore, the ideal time of DCC possibly would be clamping the cord once the placenta separates (physiological based cord clamping [PBCC]). However, there is paucity of data on neonatal outcome in delayed versus physiological based cord clamping (defined as clamping after separation of placenta) in healthy late preterm infants.
**Population:**Late preterm (34+0-36+6)) infants not requiring resuscitation
**Intervention:**Clamping the cord after separation of the placenta (cesarean section: placental separation is noted by gush of the blood and placenta coming out of the incision; vaginal delivery: placental separation is noted when the placenta has descended into the vagina with gush of blood and lengthening of the cord)
**Control:**Clamping cord at 60 seconds
**Outcomes:**Serum ferritin level at 6-8 weeks
Reaearch question: Does physiological-based cord clamping (PBCC; clamping the cord after separation of placenta) (I) among late preterm infants (34+0-36+6 weeks) not requiring
resuscitation (P) improves serum ferritin levels at 6-8 weeks (O) as compared to one-minute based delayed cord clamping (C)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 2.00 Month(s)（—）
- 性别
- All
入选标准
- •Late preterm (34+
- •36+6 weeks) singleton pregnancy with anticipated delivery (gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available)
- •Parents residing within 100 kilometers of Jodhpur & consenting to follow up till first 6-8 weeks of age.
排除标准
- •Cesarean section under general anesthesia (GA) due to any reason (contra-indication or procedure failure or failure of effect of spinal anesthesia)
- •Multiple gestation
- •Psychiatric illness or maternal drugs which may interfere or prohibits breastfeeding
- •Mothers with HIV or AIDS
- •Rh iso-immunized pregnancy with evidence of hydrops fetalis
- •Non-immune hydrops fetalis
- •Any suspected or confirmed congenital anomaly or syndrome in the fetus
- •Chorioamnionitis or any systemic infection in last one week before delivery
- •Severe fetal growth restriction (fetal weight less than 3rd centile for that gestational age) or AEDF or REDF (absent end diastolic flow or reversed end diastolic flow.
结局指标
主要结局
Primary outcome:
时间窗: six to eight weeks
1. Serum ferritin levels at 6-8 weeks of age
时间窗: six to eight weeks
次要结局
- Neonatal(I. To compare birth weight)
- VI. To compare incidence of respiratory support requirement due to any cause till discharge(VII. To compare NICU admission till discharge)
- } Maternal(I. To compare incidence of PPH)
研究者
Dr Neeraj Gupta
AIIMS Jodhpur