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临床试验/NCT04052984
NCT04052984已完成不适用

Delayed Cord Clamping and Early Skin-to-skin Contact in Cesarean Section as Interventions That Promote Exclusive Breastfeeding

Asociacion Mexicana de Nacimiento Respetado, A.C.0 个研究点目标入组 48 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
主要终点
Duration of feeding to the exclusive maternal breast

研究概览

简要总结

Delayed umbilical cord clamping as well as immediate skin-to-skin contact between mother and newborn are emerging practices due to documented benefits. However, in caesarean sections it is not common.

The investigators evaluate twenty four pares of healthy mothers-newborns, with delayed clamping and immediate skin-to-skin contact after birth by caesarean section (intervention grup), compared to the same number of pairs attended by the same group of physicians under traditional techniques (control group). In both groups, morbidity and mortality as well as sole breastfeeding was evaluated for at least 6 months. The patients in the intervention group signed an informed consent form and the protocol was approved by an ethics committee.

详细描述

BACKGROUND: Delayed umbilical cord clamping as well as immediate skin-to-skin contact between mother and newborn are emerging practices due to documented benefits for the mother-child binomial. The American Academy of Pediatrics, through the neonatal resuscitation program, considers that late clamping should be a common practice in all healthy babies, but in the case of a baby at risk, it recommends cutting the umbilical cord early and treating newborn on radiant warmer for resuscitation. Caesarean birth is considered a risk factor.

In Mexico and in many other countries early contact, skin to skin between the mother and child in Cesarean sections, is not common.

The World Health Organization (WHO), among multiple strategies to promote breastfeeding, promotes skin-to-skin contact at birth, that is: "to place babies with their mothers since birth minimal an hour or until the baby has been fed to the mother's breast". Different publications has determined that the ideal period to strengthen breastfeeding corresponds to the first minutes of life and does not go beyond the first 2 hours. Because it is usual to take care of the baby in radiant warmer, away from his mother, in caesarean sections, these recommendations are generally not met.

Searching the benefit of delayed cut of the umbilical cord, researchers began placing healthy babies in their mother's chest, even in cesarean deliveries, thus generating immediate skin-to-skin contact and incidentally an increase in the frequency of breastfeeding during the first six months, so a protocol was initiated to compare the morbidity and mortality of this technique in relation to traditional care (immediate cut of the umbilical cord and separation mother-child) and follow-up of babies at least six months to register the form of breastfeeding.

MATERIAL AND METHODS: Pilot study. All healthy mother-neonates binomials, obtained by caesarean section by the same medical team in 3 private hospitals, born between January 2015 and August 2017 in Villahermosa, Tabasco, Mexico followed for a minimum of 6 months in the private consultation were included. They were compared with an equal number of historical binomials, attended by the same medical team under the traditional technique and with the same follow-up time. The variables in this group were collected from their files.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Controlled pregnancies
  • Pregnancies not complicated
  • Single product
  • Signed the informed consent to participate in the protocol
  • Product obtained by caesarean section.

排除标准

  • Patients who did not wish to participate in the study
  • Infants with prenatally suspected or diagnosticated congenital defects
  • Multiple pregnancy
  • Cases requesting to collect umbilical cord blood for storage in a cord cell bank
  • Vaginal delivery

结局指标

主要结局

Duration of feeding to the exclusive maternal breast

时间窗: six months or more

Time in months when the newborn was fed to the exclusive maternal breast

次要结局

未报告次要终点

研究者

发起方
Asociacion Mexicana de Nacimiento Respetado, A.C.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Farid Adán Pacheco Y Orozco

Investigator

Asociacion Mexicana de Nacimiento Respetado, A.C.

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