Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04052984
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2019-08-05
Brief Title:
Interventions That Promote Exclusive Breastfeeding
Sponsor:
Asociacion Mexicana de Nacimiento Respetado AC
Organization:
Asociacion Mexicana de Nacimiento Respetado AC
Study Overview
Official Title:
Delayed Cord Clamping and Early Skin-to-skin Contact in Cesarean Section as Interventions That Promote Exclusive Breastfeeding
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 mothers 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 mothers 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
By protocol of the medical group in both groups it was encouraged to carry out an adequate program of exclusive breastfeeding as marked by the World Health Organization consisting of starting breastfeeding in the first hour of life that the Infant only received breast milk excluding other beverages such as water teas or food that breastfeeding was made on demand as often as the child wanted both day and night and no bottles or pacifiers were used during his hospital stay
The statistical evaluation included univariate analysis with frequencies and proportions for qualitative variables measures of central tendency and dispersion for qualitative variables In the bivariate analysis X2 or Fishers Exact test and Students t or Mann Whitney U were used as appropriate
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 mothers 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 mothers 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
By protocol of the medical group in both groups it was encouraged to carry out an adequate program of exclusive breastfeeding as marked by the World Health Organization consisting of starting breastfeeding in the first hour of life that the Infant only received breast milk excluding other beverages such as water teas or food that breastfeeding was made on demand as often as the child wanted both day and night and no bottles or pacifiers were used during his hospital stay
The statistical evaluation included univariate analysis with frequencies and proportions for qualitative variables measures of central tendency and dispersion for qualitative variables In the bivariate analysis X2 or Fishers Exact test and Students t or Mann Whitney U were used as appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None