Interventions That Promote Exclusive Breastfeeding

Sponsor

Asociacion Mexicana de Nacimiento Respetado, A.C. (Other)

Overall Status

Completed

CT.gov ID

NCT04052984

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding, Exclusive	Procedure: Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

An intervention group compared to a similar historical group attended by the same group of doctors at an immediate previous timeAn intervention group compared to a similar historical group attended by the same group of doctors at an immediate previous time

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Twenty four pares of healthy mothers-newborns, with delayed clamping and immediate skin-to-skin contact after birth by caesarean section	Procedure: Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section Mother: Placement of the insulating surgical arch was on the skin, between the abdomen and the thorax, electrocautery plate on the back, the gown superimposed, non-invasive blood pressure monitoring in legs and ear oximetry. The newborn was placed immediately on the mother's chest, passing it under the insulating arch and removing the mother's gown. Non-invasive monitoring was initiated with preductal pulse oximetry. The obstetrician cut the umbilical cord by not feeling the beats of the cord, or until 5 minutes. The newborn was reanimated without separating the baby from his mother. The temperature was taken with an infrared thermometer. Pulse oximetry was recorded. The newborn was colocated to the mother's breast as soon as possible, even if the mother was still in surgery. The mother's transfer to her room was with her baby skin to skin. The support staff was instructed not to separate the newborn until breast feeding occur for the first time or the mother required it.
No Intervention: Control group Twenty four pares of healthy mothers-newborns, with early clamping without skin-to-skin contact after birth by caesarean section and newborn attended in radiant warm table

Arm

Intervention/Treatment

Experimental: Intervention group

Twenty four pares of healthy mothers-newborns, with delayed clamping and immediate skin-to-skin contact after birth by caesarean section

Procedure: Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section

Mother: Placement of the insulating surgical arch was on the skin, between the abdomen and the thorax, electrocautery plate on the back, the gown superimposed, non-invasive blood pressure monitoring in legs and ear oximetry. The newborn was placed immediately on the mother's chest, passing it under the insulating arch and removing the mother's gown. Non-invasive monitoring was initiated with preductal pulse oximetry. The obstetrician cut the umbilical cord by not feeling the beats of the cord, or until 5 minutes. The newborn was reanimated without separating the baby from his mother. The temperature was taken with an infrared thermometer. Pulse oximetry was recorded. The newborn was colocated to the mother's breast as soon as possible, even if the mother was still in surgery. The mother's transfer to her room was with her baby skin to skin. The support staff was instructed not to separate the newborn until breast feeding occur for the first time or the mother required it.

No Intervention: Control group

Twenty four pares of healthy mothers-newborns, with early clamping without skin-to-skin contact after birth by caesarean section and newborn attended in radiant warm table

Outcome Measures

Primary Outcome Measures

Duration of feeding to the exclusive maternal breast [six months or more]
Time in months when the newborn was fed to the exclusive maternal breast

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Asociacion Mexicana de Nacimiento Respetado, A.C.

Investigators

Principal Investigator: FARID ADAN PACHECO Y OROZCO, MD, Asociación Mexicana del Nacimiento Respetado

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Farid Adán Pacheco Y Orozco, Investigator, Asociacion Mexicana de Nacimiento Respetado, A.C.

ClinicalTrials.gov Identifier:

NCT04052984

Other Study ID Numbers:

First Posted:

Aug 12, 2019

Last Update Posted:

Jul 13, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Farid Adán Pacheco Y Orozco, Investigator, Asociacion Mexicana de Nacimiento Respetado, A.C.

Cesarean Section

Umbilical cord

Breastfeeding

Study Results

No Results Posted as of Jul 13, 2020