Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

June 27, 2013 updated by: Miguel Angel Marin Gabriel, Puerta de Hierro University Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28220
        • Hospital Universitario Puerta de Hierro-Majadahonda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Maternity ward of a terciary Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Not exposed to oxytocin
Mother-child dyads in which Oxt had not been administered during the birth process
Drug: Oxytocin
Comparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.
Time Frame: 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).
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 months.
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Investigators

  • Principal Investigator: Miguel A Marín, MD, Hospital Universitario Puerta de Hierro-Majadahonda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI10/00791

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oxytocin

Clinical Trials on Oxytocin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe