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Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

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ClinicalTrials.gov Identifier: NCT01891201
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
Miguel Angel Marin Gabriel, 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

Condition or disease Intervention/treatment
Bonding Oxytocin Breastfeeding Newborn Perinatal Drug: Oxytocin

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Study Start Date : March 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Oxytocin

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




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Maternity ward of a terciary Hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891201


Locations
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Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Madrid, Spain, 28220
Sponsors and Collaborators
Puerta de Hierro University Hospital
Investigators
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Principal Investigator: Miguel A Marín, MD Hospital Universitario Puerta de Hierro-Majadahonda
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Miguel Angel Marin Gabriel, MD Pediatrics-Neonatology, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01891201    
Other Study ID Numbers: PI10/00791
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: June 2013
Keywords provided by Miguel Angel Marin Gabriel, Puerta de Hierro University Hospital:
Bonding
Oxytocin
Breastfeeding
Newborn
Delivery
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs