Clinical trial NCT04052984: Interventions That Promote Exclusive Breastfeeding
Official title: Delayed Cord Clamping and Early Skin-to-skin Contact in Cesarean Section as Interventions That Promote Exclusive Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Keywords: Cesarean Section
Umbilical cord
Breastfeeding
Lead sponsor: Asociacion Mexicana de Nacimiento Respetado, A.C.
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 48
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: An intervention group compared to a similar historical group attended by the same group of doctors at an immediate previous time
Primary purpose: OTHER

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.

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 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.

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 Fisher's Exact test) and Student's t (or Mann Whitney U) were used, as appropriate.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Duration of feeding to the exclusive maternal breast
timeFrame: six months or more
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asociación Mexicana del Nacimiento Respetado
name: FARID ADAN PACHECO Y OROZCO, MD
role: PRINCIPAL_INVESTIGATOR
References:
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