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Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01891201
Enrollment
98
Registered
2013-07-03
Start date
2011-03-31
Completion date
2013-06-30
Last updated
2013-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bonding, Breastfeeding, Newborn, Oxytocin, Perinatal

Keywords

Bonding, Oxytocin, Breastfeeding, Newborn, Delivery

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.

Interventions

DRUGOxytocin

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

Sponsors

Puerta de Hierro University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 4 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.72 hoursNeonatal 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

MeasureTime frameDescription
Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 months.6 monthsTo 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026