Interventions That Promote Exclusive Breastfeeding

NCT04052984 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breastfeeding, Exclusive

Keywords

Cesarean Section; Umbilical cord; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Duration of feeding to the exclusive maternal breast

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

  six months or more

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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

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.

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asociacion Mexicana de Nacimiento Respetado, A.C.: lead

Related Publications (16)

• Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.

  PMID: 17374818 BACKGROUND

• Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.

  PMID: 28526223 BACKGROUND

• Vatansever B, Demirel G, Ciler Eren E, Erel O, Neselioglu S, Karavar HN, Gundogdu S, Ulfer G, Bahadir S, Tastekin A. Is early cord clamping, delayed cord clamping or cord milking best? J Matern Fetal Neonatal Med. 2018 Apr;31(7):877-880. doi: 10.1080/14767058.2017.1300647. Epub 2017 Mar 20.

  PMID: 28320218 BACKGROUND

• Koopman I, Callaghan-Koru JA, Alaofin O, Argani CH, Farzin A. Early skin-to-skin contact for healthy full-term infants after vaginal and caesarean delivery: a qualitative study on clinician perspectives. J Clin Nurs. 2016 May;25(9-10):1367-76. doi: 10.1111/jocn.13227. Epub 2016 Mar 30.

  PMID: 27027262 BACKGROUND

• Stevens J, Schmied V, Burns E, Dahlen H. Immediate or early skin-to-skin contact after a Caesarean section: a review of the literature. Matern Child Nutr. 2014 Oct;10(4):456-73. doi: 10.1111/mcn.12128. Epub 2014 Apr 10.

  PMID: 24720501 BACKGROUND

• Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Reprint). Pediatrics. 2015 Nov;136 Suppl 2:S196-218. doi: 10.1542/peds.2015-3373G. Epub 2015 Oct 14. No abstract available.

  PMID: 26471383 BACKGROUND

• Kumar P, Yamada NK, Fuerch JH, Halamek LP. The neonatal resuscitation program: current recommendations and a look at the future. Indian J Pediatr. 2014 May;81(5):473-80. doi: 10.1007/s12098-013-1332-0. Epub 2014 Mar 22.

  PMID: 24652267 BACKGROUND

• Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.

  PMID: 28231274 BACKGROUND

• Brimdyr K, Cadwell K, Stevens J, Takahashi Y. An implementation algorithm to improve skin-to-skin practice in the first hour after birth. Matern Child Nutr. 2018 Apr;14(2):e12571. doi: 10.1111/mcn.12571. Epub 2017 Dec 12.

  PMID: 29230957 BACKGROUND

• Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.

  PMID: 27885658 BACKGROUND

• World Health Organization Human Reproduction Programme, 10 April 2015. WHO Statement on caesarean section rates. Reprod Health Matters. 2015 May;23(45):149-50. doi: 10.1016/j.rhm.2015.07.007. Epub 2015 Jul 27. No abstract available.

  PMID: 26278843 BACKGROUND

• Gomez Papi A, Baiges Nogues MT, Batiste Fernandez MT, Marca Gutierrez MM, Nieto Jurado A, Closa Monasterolo R. [Kangaroo method in delivery room for full-term babies]. An Esp Pediatr. 1998 Jun;48(6):631-3. Spanish.

  PMID: 9662849 BACKGROUND

• Beake S, Bick D, Narracott C, Chang YS. Interventions for women who have a caesarean birth to increase uptake and duration of breastfeeding: A systematic review. Matern Child Nutr. 2017 Oct;13(4):e12390. doi: 10.1111/mcn.12390. Epub 2016 Nov 24.

  PMID: 27882659 BACKGROUND

• Diaz-Castro J, Florido J, Kajarabille N, Garrido-Sanchez M, Padilla C, de Paco C, Navarrete L, Ochoa JJ. The timing of cord clamping and oxidative stress in term newborns. Pediatrics. 2014 Aug;134(2):257-64. doi: 10.1542/peds.2013-3798. Epub 2014 Jul 14.

  PMID: 25022744 BACKGROUND

• Hooper SB, Binder-Heschl C, Polglase GR, Gill AW, Kluckow M, Wallace EM, Blank D, Te Pas AB. The timing of umbilical cord clamping at birth: physiological considerations. Matern Health Neonatol Perinatol. 2016 Jun 13;2:4. doi: 10.1186/s40748-016-0032-y. eCollection 2016.

  PMID: 27298730 BACKGROUND

• van Rheenen PF, Brabin BJ. A practical approach to timing cord clamping in resource poor settings. BMJ. 2006 Nov 4;333(7575):954-8. doi: 10.1136/bmj.39002.389236.BE. No abstract available.

  PMID: 17082547 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• FARID ADAN PACHECO Y OROZCO, MD

  Asociación Mexicana del Nacimiento Respetado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

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

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 12, 2019
• Study Start: January 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

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