Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

NCT ID: NCT01891201

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Bonding; Oxytocin; Breastfeeding; Newborn; Perinatal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Not exposed to oxytocin

Mother-child dyads in which Oxt had not been administered during the birth process

Oxytocin

Intervention Type: DRUG

Comparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin

Interventions

Oxytocin

Comparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 4 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puerta de Hierro University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Miguel Angel Marin Gabriel

MD Pediatrics-Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel A Marín, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro-Majadahonda

Locations

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, Madrid, Spain

Countries

Spain

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Other Identifiers

PI10/00791

Identifier Type: -

Identifier Source: org_study_id