Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

Completed

• Conditions: Bonding; Oxytocin; Breastfeeding; Newborn; Perinatal
• Interventions: Drug: Oxytocin

• Registration Number: NCT01891201
• Lead Sponsor: Puerta de Hierro University Hospital

Brief Summary

The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary objective is to assess the effects on exclusive breastfeeding at 3 months

Detailed Description

Patients and Methods Prospective case-control study performed in a tertiary hospital. Cases: mother-child dyads in which Oxt had been administered during the birth process (n = 53). Controls: mother-child dyads without Oxt (n = 45). The RNP were recorded with a camcorder in biological nurturing position. An observer blinded to the group and the dose of Oxt codified the RNP (reach/not reached). To assess the type of breastfeeding telephone call was made at 3 months old RN.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-01
• Status Verified: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Study First Posted: 2013-07-03
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Healthy singleton term infant delivered vaginally with Apgar at 5 min> 7;
• Expressed desire to administer during pregnancy breastfeeding;
• Signed informed consent

Exclusion Criteria

• Preterm neonate;
• Fetal chromosomal or other abnormalities diagnosed in utero to modify their adaptation to extrauterine environment;
• Hospitalization of the mother in ICU;
• Hospitalization in the following 48 hours neonate at birth;
• Wish to artificial feeding before parturition;
• Language difficulties;
• Completion of caesarean delivery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Not exposed to oxytocin	Oxytocin	Mother-child dyads in which Oxt had not been administered during the birth process

Primary Outcome Measures

Name	Time	Method
Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.	72 hours	Neonatal Primitive Reflexes studied were: 1) Endogenous: hand to mouth, extension / flexion of fingers, mouth open, tongue extrusion, arm circular motion, circular motion of the leg, flex foot / hand, 2) Antigravity: raise the head, 3) Motors: turn your head, nod, plantar pressure, Babinski, and 4) Rhythmic: suction, jaw movement and swallowing.; An observer, blinded to the study group and the dose administered of Oxytocin, valued recordings, analyzing the state of consciousness at the beginning of the recording as Brazelton scale and form RNP dichotomous coding (achieved / not achieved).

Secondary Outcome Measures

Name	Time	Method
Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 months.	6 months	To assess the type of feeding (exclusive breastfeeding versus other) at different time points (discharge, one month and three months) a telephone call was conducted at 3 months old of the newborn.

Trial Locations

Locations (1)

Hospital Universitario Puerta de Hierro-Majadahonda; 🇪🇸 Madrid, Spain