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Trial · Observational

CompletedPhase not statedRegistry data

Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

Overview

Status
Completed
Phase
Phase not stated
Enrollment
98 participants (actual)
Sponsor
Puerta de Hierro University Hospital · Other
Design
Not stated
Countries
1 country

Spain

Start
Mar 2011
Primary completion
Jan 2013
Completion
Jun 2013
First posted
3 Jul 2013 (estimated)
Last update posted
3 Jul 2013 (estimated)
Conditions
Bonding · Oxytocin · Breastfeeding · Newborn · Perinatal

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph –

    Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

    NCT01891201

    Mar 2011 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • OxytocinDrug

Arms1

  • Other

    Not exposed to oxytocin

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.

    Time frame · 72 hours

    Registry description

    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 outcomes(1)
  1. Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 months.

    Time frame · 6 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies31

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

4 results

Oxytocin shapes the neural circuitry of trust and trust adaptation in humans.

Baumgartner et al. 2008Neuroncited by 700

PMID 18498743DOI 10.1016/j.neuron.2008.04.009PUB-18498743

Rights unknown4 results

More studies

30 studies on this page

Indexing hint: Observational study · 2015

Intrapartum synthetic oxytocin reduce the expression of primitive reflexes associated with breastfeeding.

Marín Gabriel et al. 2015Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicinecited by 28

PMID 25785487PMC4410763DOI 10.1089/bfm.2014.0156PUB-25785487

Rights unknown
Source link

PubMed tag: none · 2013

Fetal exposure to synthetic oxytocin and the relationship with prefeeding cues within one hour postbirth.

Bell et al. 2013Early human developmentcited by 35

PMID 23084698DOI 10.1016/j.earlhumdev.2012.09.017PUB-23084698

Full text at the publisher
Publisher page

Indexing hint: Review · 2012

Oxytocin and social affiliation in humans.

Feldman et al. 2012Hormones and behaviorcited by 408

PMID 22285934DOI 10.1016/j.yhbeh.2012.01.008PUB-22285934

Full text at the publisher
Publisher page

Indexing hint: Clinical trial · 2012

Newborn feeding behaviour depressed by intrapartum oxytocin: a pilot study.

Olza Fernández et al. 2012Acta paediatrica (Oslo, Norway : 1992)cited by 58

PMID 22452314DOI 10.1111/j.1651-2227.2012.02668.xPUB-22452314

Full text at the publisher
Publisher page

Indexing hint: Review · 2011

Oxytocin role in enhancing well-being: a literature review.

Ishak et al. 2011Journal of affective disorderscited by 108

PMID 20584551DOI 10.1016/j.jad.2010.06.001PUB-20584551

Full text at the publisher
Publisher page

Indexing hint: Review · 2010

Oxytocin as feeding inhibitor: maintaining homeostasis in consummatory behavior.

Olszewski et al. 2010Pharmacology, biochemistry, and behaviorcited by 76

PMID 20595062PMC2952698DOI 10.1016/j.pbb.2010.05.026PUB-20595062

Rights unknown
Source link

Indexing hint: Animal study · 2010

Molecular, immunohistochemical, and pharmacological evidence of oxytocin's role as inhibitor of carbohydrate but not fat intake.

Olszewski et al. 2010Endocrinologycited by 94

PMID 20685878PMC2946140DOI 10.1210/en.2010-0151PUB-20685878

Rights unknown
Source link

Indexing hint: Observational study · 2009

Epidural analgesia: breast-feeding success and related factors.

Wiklund et al. 2009Midwiferycited by 62

PMID 17980469DOI 10.1016/j.midw.2007.07.005PUB-17980469

Full text at the publisher
Publisher page

Indexing hint: Observational study · 2009

Effects of intrapartum oxytocin administration and epidural analgesia on the concentration of plasma oxytocin and prolactin, in response to suckling during the second day postpartum.

Jonas et al. 2009Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicinecited by 97

PMID 19210132DOI 10.1089/bfm.2008.0002PUB-19210132

Full text at the publisher
Publisher page

Indexing hint: Review · 2009

Oxytocin and the neural mechanisms regulating social cognition and affiliative behavior.

Ross et al. 2009Frontiers in neuroendocrinologycited by 570

PMID 19481567PMC2748133DOI 10.1016/j.yfrne.2009.05.004PUB-19481567

Rights unknown
Source link

PubMed tag: none · 2009

Associations of drugs routinely given in labour with breastfeeding at 48 hours: analysis of the Cardiff Births Survey.

Jordan et al. 2009BJOG : an international journal of obstetrics and gynaecologycited by 51

PMID 19735379DOI 10.1111/j.1471-0528.2009.02256.xPUB-19735379

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2009

Oxytocin and carbetocin effects on spontaneous behavior of male rats: modulation by oxytocin receptor antagonists.

Klenerova et al. 2009Neuro endocrinology letterscited by 24

PMID 19855356PUB-19855356

Full text at the publisher

Indexing hint: Observational study · 2005

Functional magnetic resonance imaging shows oxytocin activates brain regions associated with mother-pup bonding during suckling.

Febo et al. 2005The Journal of neuroscience : the official journal of the Society for Neurosciencecited by 132

PMID 16354922PMC6726012DOI 10.1523/jneurosci.3604-05.2005PUB-16354922

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Review · 2004

Could oxytocin administration during labor contribute to autism and related behavioral disorders?--A look at the literature.

Wahl et al. 2004Medical hypothesescited by 55

PMID 15288368DOI 10.1016/j.mehy.2004.03.008PUB-15288368

Full text at the publisher
Publisher page

Indexing hint: In vitro study · 2003

Oxytocin-induced desensitization of the oxytocin receptor.

Robinson et al. 2003American journal of obstetrics and gynecologycited by 109

PMID 12592262DOI 10.1067/mob.2003.22PUB-12592262

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Indexing hint: Review · 2003

Developmental consequences of oxytocin.

Carter et al. 2003Physiology & behaviorcited by 227

PMID 12954433DOI 10.1016/s0031-9384(03)00151-3PUB-12954433

Full text at the publisher
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Indexing hint: Review · 2002

The social deficits of the oxytocin knockout mouse.

Winslow et al. 2002Neuropeptidescited by 205

PMID 12359512DOI 10.1054/npep.2002.0909PUB-12359512

Full text at the publisher
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PubMed tag: none · 2002

Plasma oxytocin levels in women during labor with or without epidural analgesia: a prospective study.

Rahm et al. 2002Acta obstetricia et gynecologica Scandinavicacited by 72

PMID 12421171DOI 10.1034/j.1600-0412.2002.811107.xPUB-12421171

Full text at the publisher
Publisher page

Indexing hint: Review · 2001

The oxytocin receptor system: structure, function, and regulation.

Gimpl et al. 2001Physiological reviewscited by 2,174

PMID 11274341DOI 10.1152/physrev.2001.81.2.629PUB-11274341

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2001

Naturally occurring variations in maternal behavior in the rat are associated with differences in estrogen-inducible central oxytocin receptors.

Champagne et al. 2001Proceedings of the National Academy of Sciences of the United States of Americacited by 507

PMID 11606726PMC60123DOI 10.1073/pnas.221224598PUB-11606726

Rights unknown
Source link

PubMed tag: none · 2000

Loss of myometrial oxytocin receptors during oxytocin-induced and oxytocin-augmented labour.

Phaneuf et al. 2000Journal of reproduction and fertilitycited by 148

PMID 11006150DOI 10.1530/jrf.0.1200091PUB-11006150

Rights unknown
Source link

Indexing hint: Animal study · 2000

Variations in maternal behaviour are associated with differences in oxytocin receptor levels in the rat.

Francis et al. 2000Journal of neuroendocrinologycited by 339

PMID 11106970DOI 10.1046/j.1365-2826.2000.00599.xPUB-11106970

Full text at the publisher
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PubMed tag: none · 1999

The effect of labour and maternal oxytocin infusion on fetal plasma oxytocin concentration.

Patient et al. 1999British journal of obstetrics and gynaecologycited by 25

PMID 10609728DOI 10.1111/j.1471-0528.1999.tb08188.xPUB-10609728

Full text at the publisher
Publisher page

Indexing hint: In vitro study · 1997

The desensitization of oxytocin receptors in human myometrial cells is accompanied by down-regulation of oxytocin receptor messenger RNA.

Phaneuf et al. 1997The Journal of endocrinologycited by 80

PMID 9246933DOI 10.1677/joe.0.1540007PUB-09246933

Full text at the publisher
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Indexing hint: In vitro study · 1996

Human placental transport of oxytocin.

Malek et al. 1996The Journal of maternal-fetal medicinecited by 78

PMID 8930795DOI 10.1002/(sici)1520-6661(199609/10)5:5<245::aid-mfm3>3.0.co;2-hPUB-08930795

Full text at the publisher
Publisher page

Indexing hint: Animal study · 1992

Oxytocin and social bonding.

Carter et al. 1992Annals of the New York Academy of Sciencescited by 145

PMID 1626829DOI 10.1111/j.1749-6632.1992.tb34356.xPUB-01626829

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Indexing hint: Animal study · 1990

Oxytocin inhibits food and fluid intake in rats.

Arletti et al. 1990Physiology & behaviorcited by 198

PMID 2087513DOI 10.1016/0031-9384(90)90234-uPUB-02087513

Full text at the publisher
Publisher page

Indexing hint: Animal study · 1985

On the blood-brain barrier to peptides: accumulation of labelled vasopressin, DesGlyNH2-vasopressin and oxytocin by brain regions.

Ermisch et al. 1985Endocrinologia experimentaliscited by 92

PMID 3872788PUB-03872788

Full text at the publisher

Indexing hint: Observational study · 1978

Induction of labour by different methods in primiparous women. I Some perinatal and postnatal problems.

Ounsted et al. 1978Early human developmentcited by 14

PMID 551927DOI 10.1016/0378-3782(78)90027-0PUB-00551927

Full text at the publisher
Publisher page

PubMed tag: none · 1969

Half-life of oxytocin in blood of pregnant and non-pregnant women.

Rydén et al. 1969Acta endocrinologicacited by 36

PMID 5820054DOI 10.1530/acta.0.0610425PUB-05820054

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Day up to 4 Days
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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