Early Versus Inmediately Skin to Skin Contact in Cesarean Section

NCT05292924 | Unknown

• 1 other identifier: Skin-to-Skin-cesarean
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

Breastfeeding plays a fundamental role in the health of girls and boys by providing adequate nutrition, promoting development and mainly preventing diseases. Different maternal factors such as education or obesity and perinatal factors such as the route of birth or skin-to-skin contact, among many others, can influence its onset, proper establishment and duration. Caesarean section and instrumental delivery are directly related to a delay in the early initiation of breastfeeding in newborns. In Mexico, the rate of caesarean sections is well above that recommended by the World Health Organization, in addition to being a country with very low rates of exclusive breastfeeding at 6 months of age of the newborn without having achieved the proposed objectives to improve it in recent years. Newborns who experience skin-to-skin contact with their mother develop behaviors such as crawling to the breast and more effective suckling with greater lactogenesis by the mother. The World Health Organization (WHO) defines skin-to-skin contact (SSC) as "direct, immediate and uninterrupted contact of the infant with the mother's skin" and promotes it because it is important for establishment of breastfeeding, neonatal and child survival and development. It has been seen that the ideal time to start this CPP is within the first 30 minutes of life of the newborn in any birth route, so it has been recommended that it be started in the recovery room or even in the operating room during birth by caesarean section in order to make a mark in the programming of the future physiology and behavior of the dyad. The foregoing leads us to ask ourselves the following research questions: Can we in our public hospitals in Mexico carry out the CPP procedure between mother and baby during cesarean births? And if so, will there be a difference in breastfeeding by Mexican women, performing skin-to-skin contact immediately even in the operating room between mother and baby in cesarean births versus if it is carried out after the surgical procedure?

Conditions

Breastfeeding, Exclusive; Mother-Child Relations; Kangaroo-mother Care

Keywords

Birth; Cesarean Section; Skin-to-skin contact; Mother-Child Relations; Breastfeeding; kangaroo-mother care

Outcome Measures

Primary Outcomes (1)

• Breastfeeding

  Feeding to the exclusive mother's breast at least six months after birth

  Six months

Study Arms (2)

Early SSC

EXPERIMENTAL

Cesarean delivery and SSC within the first 30 minutes of birth

Procedure: Early SCC

Control

NO INTERVENTION

Cesarean delivery and SSC one hour after birth

Interventions

Early SCC PROCEDURE

Direct, immediate and uninterrupted contact of the infant with its mother's skin first 30 minutes delivery

Early SSC

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Elimination criteria: Participants who decide not to continue with the study, who do not answer the evaluation surveys on breastfeeding or who do not return for follow-up.

Sponsors & Collaborators

• Asociación Mexicana de Salud Primal: lead

Related Publications (15)

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  PMID: 24252711 BACKGROUND

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  PMID: 26566028 BACKGROUND

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Related Links

• Guía para la aplicación: proteger, promover y apoyar la lactancia materna en los establecimientos que prestan servicios de maternidad y neonatología - Revisión de la Iniciativa Hospitales Amigos del Niño 2018
• Contacto Piel a Piel en cesáreasa
• Pinzamiento temprano vs tardío del cordón umbilical y contacto piel a piel inmediato en nacimientos por cesárea.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate of social sciences

Model Details: 6000 births per year were considered, of which 30% correspond to births by cesarean section. For a non-random and voluntary sampling with a homogeneous population and a sampling error of 5%, at a confidence level of 95%, the sample size is 278. Of this number of participants, 50% will be assigned to the experimental group (birth by cesarean section and EFS within the first 30 minutes of birth) and 50% to the control group (caesarean birth and EFS one hour after birth) by simple randomization.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 23, 2022
• Study Start: July 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Permanently
• Access Criteria: request via email