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肯尼亚脐带挤奶与延迟结扎脐带对早产儿的影响:一项随机对照试验。

Effect of umbilical cord milking versus delayed cord clamping on preterm neonates in Kenya: A randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, College of Health Sciences, University of Nairobi, Nairobi, Kenya.

Department of Global Health, The University of Washington, Seattle, Washington, United States of America.

出版信息

PLoS One. 2021 Jan 26;16(1):e0246109. doi: 10.1371/journal.pone.0246109. eCollection 2021.

Abstract

BACKGROUND

Delayed cord clamping (DCC) is a placental to new-born transfusion strategy recommended by obstetric and gynaecological societies. Though not widely adopted, umbilical cord milking (UCM) may achieve faster transfusion when DCC cannot be performed such as when a neonate requires resuscitation.

METHODS

Pragmatic, two-arm, randomized clinical trial in which consenting women in spontaneous labour or provider-initiated delivery at 28 to less than 37 weeks at Kenyatta National Hospital in Nairobi, Kenya, were enrolled. At delivery, stable preterm infants were randomized to UCM (4 times) or DCC (60 seconds). Neonatal samples were collected for analysis at 24 hours after delivery. Maternal primary PPH (within 24 hours) and neonatal jaundice (within 1 week) were evaluated clinically. The primary outcome was the mean neonatal haemoglobin level at 24 hours after birth. Modified Intention to treat analysis was used for all outcomes. P-value was significant at p<0.05.

RESULTS

Between March 2018 to March 2019, 344 pregnant women underwent screening, and 280 eligible participants were randomized when delivery was imminent. The intervention was not performed on 19 ineligible neonates. Of the remaining 260 neonates, 133 underwent UCM while 128 underwent DCC. Maternal and neonatal baseline characteristics were similar. The mean neonatal haemoglobin (17.1 vs 17.5 grams per decilitre, p = 0.191), haematocrit (49.6% vs 50.3%, p = 0.362), anaemia (9.8% vs 11.7%, p = 0.627), maternal PPH (2.3% vs 3.1%, p = 0.719) were similar between UCM and DCC respectfully. However, neonatal polycythaemia (2.3% vs 8.6%, p = 0.024) and neonatal jaundice (6.8% vs 15.6%, p = 0.024) were statistically significantly lower in UCM compared to DCC.

CONCLUSION

UCM compared to DCC for preterm neonates resulted in similar outcomes for neonatal haemoglobin, haematocrit, anaemia and maternal primary PPH and a lower proportion of neonatal polycythaemia and clinical jaundice. UCM offers a comparable method of placental transfusion compared to DCC and may be considered as an alternative to DCC in preterm neonates at 28 to <37 weeks' gestation.

摘要

背景

延迟脐带夹闭(DCC)是妇产科协会推荐的胎盘向新生儿输血策略。尽管尚未广泛采用,但当不能进行 DCC 时,如新生儿需要复苏,脐带挤奶(UCM)可能会更快地进行输血。

方法

这是一项在肯尼亚内罗毕肯雅塔国家医院进行的实用、双臂、随机临床试验,在自发性分娩或由提供者发起的分娩时纳入了 28 至不到 37 周的同意妇女。在分娩时,稳定的早产儿被随机分配到 UCM(4 次)或 DCC(60 秒)。在分娩后 24 小时收集新生儿样本进行分析。临床评估产妇原发性产后出血(24 小时内)和新生儿黄疸(1 周内)。主要结局是出生后 24 小时新生儿的平均血红蛋白水平。所有结局均采用修改后的意向治疗分析。p 值在 p<0.05 时具有统计学意义。

结果

2018 年 3 月至 2019 年 3 月,344 名孕妇接受了筛查,当分娩迫在眉睫时,有 280 名符合条件的参与者被随机分配。19 名不适合的新生儿未进行干预。在其余 260 名新生儿中,133 名接受了 UCM,128 名接受了 DCC。产妇和新生儿的基线特征相似。新生儿血红蛋白(17.1 与 17.5 克/分升,p = 0.191)、血细胞比容(49.6%与 50.3%,p = 0.362)、贫血(9.8%与 11.7%,p = 0.627)、产妇产后出血(2.3%与 3.1%,p = 0.719)在 UCM 和 DCC 之间相似。然而,UCM 组新生儿红细胞增多症(2.3%与 8.6%,p = 0.024)和新生儿黄疸(6.8%与 15.6%,p = 0.024)的发生率明显低于 DCC 组。

结论

与 DCC 相比,UCM 用于早产儿的结果相似,新生儿血红蛋白、血细胞比容、贫血和产妇原发性产后出血相似,新生儿红细胞增多症和临床黄疸的比例较低。UCM 提供了一种与 DCC 相比具有可比性的胎盘输血方法,并且可以在 28 至<37 周妊娠的早产儿中考虑替代 DCC。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3e5/7837492/298050107a1f/pone.0246109.g001.jpg

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