Timing of Umbilical Cord Clamping and Maternal and Neonatal Outcomes, Comparing One to Three Minutes vs. After Cessation of Cord Pulsation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 580
- 试验地点
- 2
- 主要终点
- Neonatal Hyperbilirubinemia requiring phototherapy
研究概览
简要总结
The timing of umbilical cord clamping has been widely discussed in the scientific community.
As part of the worldwide strategies to reduce childhood iron deficiency anemia, the incorporation of late clamping (at least one minute after delivery), has been adopted as an effective and low-cost measure for health services.
The optimal timing for clamping, ( if until 3 minutes of delivery, or later, when the cord stops spontaneous pulse), still remains controversial.
Also, doubts remain about the effect of late clamping of the umbilical cord on maternal outcomes.
This study has the hypothesis that waiting for the cessation of the cord pulsation will not bring harm to the newborn or the mother.
详细描述
Due to several studies showing the advantages of late clamping of the umbilical cord for the newborn child. Delayed clamping from one, up to three minutes has been associated with better adaptation of the neonate to extrauterine life, with increased supply of oxygen, iron reserve in childhood, and benefits in the neuropsychic and motor development of children. It is considered a safe technique, recommended and has been recommended by obstetrics and neonatologists throughout the world, although the exact moment for its accomplishment is not aligned between countries.
Early clamping was one of the strategies of active management in the third period of delivery in order to prevent postpartum hemorrahge (PPH), which is considered a major cause of maternal mortality worldwide. Studies have not confirmed this initial hypothesis and the balancing between the advantages for the newborn, and no evidence of advantage fot he mother has shifted the management to late cord clamping, which for most professionals consists of clamping the cord from one to three minutes after birth.
On the other hand, there are still questions regarding the possibility of prolonging the cord clamping time, for an even longer time, or even stopping the cord's pulsations, as a way to favor placental drainage, reduce the time of placental detachment and consequently decrease bleeding events. It is believed that delayed clamping after pulsations cease may contribute to the increase in the blood volume transferred to the neonate, thus increasing its iron stores without any additional harm to the health of the woman and the newborn.
The subject is new, in order to verify the impact on the occurrence of neonatal jaundice and the blood loss when the cord is clamped after the pulsations cease, since there is no detailed report in any other study on this practice. Thus, it can contribute to the available evidence on the subject, and can be included in a systematic review and enable the elucidation of questions that still need to be clarified.
The study is relevant, since the conclusions may be of great use for clinical conduct, since it is a non-invasive and cost-free method that can contribute to reduce the occurrence of iron deficiency anemia in early childhood and postpartum haemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(pregnant women)
- •Low risk pregnancy;
- •Full-term pregnancy (37 to 42 weeks);
- •Single fetus;
- •Cephalic presentation;
- •Normal birth;
- •Euthocic delivery. (newborns)
- •Live birth;
- •Apgar> 7 in the first minute and fifth minutes.
排除标准
- •Early clamping for any reason (indicated by assistant);
- •Instrumental delivery (forceps);
- •Chorioamnionitis;
- •Placental abruption;
- •Prolapse of umbilical cord;
- •Congenital anomaly;
- •Labor analgesia.
研究组 & 干预措施
CONTROL
In this group management will be carried out as usual routine (cord clamping from one to three minutes after delivery)
干预措施: CONTROL (Other)
CESSATION OF CORD PULSE
In this group the umbilical cord will remain unclamped until the spontaneous pulsation stops.
At this time, cord clamping will be made.
干预措施: CESSATION OF CORD PULSE (Other)
结局指标
主要结局
Neonatal Hyperbilirubinemia requiring phototherapy
时间窗: 24 to 7 days after birth
clinical situation where hyperbilirubinemia indicates phototherapy. The need for phototherapy will be identified from the analysis of the laboratory results of total bilirubin, applying the values established by the American Academy of Pediatrics (AAP).
Neonatal hemoglobin concentration 24-48 h postpartum
时间窗: 24 to 48 hours after birth
expressed the concentration of neonatal hemoglobin, collected between 24 and 48 hours postpartum
次要结局
- Apgar Score in the first and fifth minutes(5 minutes)
- Skin-to-skin contact(5 hours)
- Duration of skin-to-skin contact(5 hours)
- Breastfeeding in the first hour after birth(1 hour)
- maternal hemoglobin 24 hours postpartum(24 hour)
- HG < 8 g / dL(24 hours)
- Uterine curage(3 hours)
- Maternal death(42 days)
- Weight of the newborn(1 hour postpartum)
- Breastfeeding until discharge(15 days)
- Hematocrit concentration 24-48 hours(24-48 hours)
- Blood loss at birth(3 hours)
- Need of ICU or NICU(28 days)
- Third period duration(3 hours)
- Blood transfusion(24 hours)
- Hyperbilirubinemia requiring exchange transfusion(7 days)
- Uterine curettage(3 hours)
- Manual removal of the placenta(3 hours)
- Treatment of PPH(24 hours)
- Maternal satisfaction(24 hours)
- Postpartum haemorrhage(24 hours)
研究者
Leila Katz
Coordinator of the Obstetrical Intensive Care Unit
Instituto Materno Infantil Prof. Fernando Figueira