Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

Breastfeeding Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891201
• Other study ID #: PI10/00791
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: June 27, 2013
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Days

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bonding
• Breastfeeding
• Newborn
• Oxytocin
• Perinatal

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (40)

Anagnostakis D, Messaritakis J, Damianos D, Mandyla H. Blood-brain barrier permeability in "healthy" infected and stressed neonates. J Pediatr. 1992 Aug;121(2):291-4. — View Citation

Arletti R, Benelli A, Bertolini A. Oxytocin inhibits food and fluid intake in rats. Physiol Behav. 1990 Dec;48(6):825-30. — View Citation

Bales KL, Lewis-Reese AD, Pfeifer LA, Kramer KM, Carter CS. Early experience affects the traits of monogamy in a sexually dimorphic manner. Dev Psychobiol. 2007 May;49(4):335-42. — View Citation

Baumgartner T, Heinrichs M, Vonlanthen A, Fischbacher U, Fehr E. Oxytocin shapes the neural circuitry of trust and trust adaptation in humans. Neuron. 2008 May 22;58(4):639-50. doi: 10.1016/j.neuron.2008.04.009. — View Citation

Bell AF, White-Traut R, Rankin K. Fetal exposure to synthetic oxytocin and the relationship with prefeeding cues within one hour postbirth. Early Hum Dev. 2013 Mar;89(3):137-43. doi: 10.1016/j.earlhumdev.2012.09.017. Epub 2012 Oct 16. — View Citation

Bu'Lock F, Woolridge MW, Baum JD. Development of co-ordination of sucking, swallowing and breathing: ultrasound study of term and preterm infants. Dev Med Child Neurol. 1990 Aug;32(8):669-78. — View Citation

Carter CS, Williams JR, Witt DM, Insel TR. Oxytocin and social bonding. Ann N Y Acad Sci. 1992 Jun 12;652:204-11. — View Citation

Carter CS. Developmental consequences of oxytocin. Physiol Behav. 2003 Aug;79(3):383-97. Review. — View Citation

Champagne F, Diorio J, Sharma S, Meaney MJ. Naturally occurring variations in maternal behavior in the rat are associated with differences in estrogen-inducible central oxytocin receptors. Proc Natl Acad Sci U S A. 2001 Oct 23;98(22):12736-41. Epub 2001 Oct 16. — View Citation

Colson SD, Meek JH, Hawdon JM. Optimal positions for the release of primitive neonatal reflexes stimulating breastfeeding. Early Hum Dev. 2008 Jul;84(7):441-9. doi: 10.1016/j.earlhumdev.2007.12.003. Epub 2008 Feb 19. — View Citation

Ermisch A, Barth T, Rühle HJ, Skopková J, Hrbas P, Landgraf R. On the blood-brain barrier to peptides: accumulation of labelled vasopressin, DesGlyNH2-vasopressin and oxytocin by brain regions. Endocrinol Exp. 1985 Mar;19(1):29-37. — View Citation

Febo M, Numan M, Ferris CF. Functional magnetic resonance imaging shows oxytocin activates brain regions associated with mother-pup bonding during suckling. J Neurosci. 2005 Dec 14;25(50):11637-44. — View Citation

Feldman R. Oxytocin and social affiliation in humans. Horm Behav. 2012 Mar;61(3):380-91. doi: 10.1016/j.yhbeh.2012.01.008. Epub 2012 Jan 20. Review. — View Citation

Francis DD, Champagne FC, Meaney MJ. Variations in maternal behaviour are associated with differences in oxytocin receptor levels in the rat. J Neuroendocrinol. 2000 Dec;12(12):1145-8. — View Citation

Gimpl G, Fahrenholz F. The oxytocin receptor system: structure, function, and regulation. Physiol Rev. 2001 Apr;81(2):629-83. Review. — View Citation

Hernández Aguilar MT, Aguayo Maldonado J; Comité de Lactancia Materna de la Asociación Española de Pediatría. [Breastfeeding. How to promote and support breastfeeding in pediatric practice. Recommendations of the Breastfeeding Committee of the Spanish Association of Pediatrics]. An Pediatr (Barc). 2005 Oct;63(4):340-56. Review. Spanish. — View Citation

Insel TR, Young LJ. The neurobiology of attachment. Nat Rev Neurosci. 2001 Feb;2(2):129-36. Review. — View Citation

Ishak WW, Kahloon M, Fakhry H. Oxytocin role in enhancing well-being: a literature review. J Affect Disord. 2011 Apr;130(1-2):1-9. doi: 10.1016/j.jad.2010.06.001. Epub 2010 Jul 2. Review. — View Citation

Jonas K, Johansson LM, Nissen E, Ejdebäck M, Ransjö-Arvidson AB, Uvnäs-Moberg K. 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. Breastfeed Med. 2009 Jun;4(2):71-82. doi: 10.1089/bfm.2008.0002. — View Citation

Jordan S, Emery S, Watkins A, Evans JD, Storey M, Morgan G. Associations of drugs routinely given in labour with breastfeeding at 48 hours: analysis of the Cardiff Births Survey. BJOG. 2009 Nov;116(12):1622-9; discussion 1630-2. doi: 10.1111/j.1471-0528.2009.02256.x. Epub 2009 Sep 1. — View Citation

Klenerova V, Krejci I, Sida P, Hlinak Z, Hynie S. Oxytocin and carbetocin effects on spontaneous behavior of male rats: modulation by oxytocin receptor antagonists. Neuro Endocrinol Lett. 2009;30(3):335-42. — View Citation

Malek A, Blann E, Mattison DR. Human placental transport of oxytocin. J Matern Fetal Med. 1996 Sep-Oct;5(5):245-55. — View Citation

Noseworthy MD, Bray TM. Effect of oxidative stress on brain damage detected by MRI and in vivo 31P-NMR. Free Radic Biol Med. 1998 Apr;24(6):942-51. — View Citation

Olszewski PK, Klockars A, Olszewska AM, Fredriksson R, Schiöth HB, Levine AS. Molecular, immunohistochemical, and pharmacological evidence of oxytocin's role as inhibitor of carbohydrate but not fat intake. Endocrinology. 2010 Oct;151(10):4736-44. doi: 10.1210/en.2010-0151. Epub 2010 Aug 4. — View Citation

Olszewski PK, Klockars A, Schiöth HB, Levine AS. Oxytocin as feeding inhibitor: maintaining homeostasis in consummatory behavior. Pharmacol Biochem Behav. 2010 Nov;97(1):47-54. doi: 10.1016/j.pbb.2010.05.026. Epub 2010 Jun 2. Review. — View Citation

Olza Fernández I, Marín Gabriel M, Malalana Martínez A, Fernández-Cañadas Morillo A, López Sánchez F, Costarelli V. Newborn feeding behaviour depressed by intrapartum oxytocin: a pilot study. Acta Paediatr. 2012 Jul;101(7):749-54. doi: 10.1111/j.1651-2227.2012.02668.x. Epub 2012 Apr 4. — View Citation

Ounsted MK, Hendrick AM, Mutch LM, Calder AA, Good FJ. Induction of labour by different methods in primiparous women. I Some perinatal and postnatal problems. Early Hum Dev. 1978 Sep;2(3):227-39. — View Citation

Patient C, Davison JM, Charlton L, Baylis PH, Thornton S. The effect of labour and maternal oxytocin infusion on fetal plasma oxytocin concentration. Br J Obstet Gynaecol. 1999 Dec;106(12):1311-3. — View Citation

Phaneuf S, Asbóth G, Carrasco MP, Europe-Finner GN, Saji F, Kimura T, Harris A, López Bernal A. The desensitization of oxytocin receptors in human myometrial cells is accompanied by down-regulation of oxytocin receptor messenger RNA. J Endocrinol. 1997 Jul;154(1):7-18. — View Citation

Phaneuf S, Rodríguez Liñares B, TambyRaja RL, MacKenzie IZ, López Bernal A. Loss of myometrial oxytocin receptors during oxytocin-induced and oxytocin-augmented labour. J Reprod Fertil. 2000 Sep;120(1):91-7. — View Citation

Rahm VA, Hallgren A, Högberg H, Hurtig I, Odlind V. Plasma oxytocin levels in women during labor with or without epidural analgesia: a prospective study. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1033-9. — View Citation

Righard L, Alade MO. Effect of delivery room routines on success of first breast-feed. Lancet. 1990 Nov 3;336(8723):1105-7. — View Citation

Robinson C, Schumann R, Zhang P, Young RC. Oxytocin-induced desensitization of the oxytocin receptor. Am J Obstet Gynecol. 2003 Feb;188(2):497-502. — View Citation

Ross HE, Young LJ. Oxytocin and the neural mechanisms regulating social cognition and affiliative behavior. Front Neuroendocrinol. 2009 Oct;30(4):534-47. doi: 10.1016/j.yfrne.2009.05.004. Epub 2009 May 28. Review. — View Citation

Rydén G, Sjöholm I. Half-life of oxytocin in blood of pregnant and non-pregnant women. Acta Endocrinol (Copenh). 1969 Jul;61(3):425-31. — View Citation

Torvaldsen S, Roberts CL, Simpson JM, Thompson JF, Ellwood DA. Intrapartum epidural analgesia and breastfeeding: a prospective cohort study. Int Breastfeed J. 2006 Dec 11;1:24. — View Citation

Wahl RU. Could oxytocin administration during labor contribute to autism and related behavioral disorders?--A look at the literature. Med Hypotheses. 2004;63(3):456-60. Review. — View Citation

Widström AM, Ransjö-Arvidson AB, Christensson K, Matthiesen AS, Winberg J, Uvnäs-Moberg K. Gastric suction in healthy newborn infants. Effects on circulation and developing feeding behaviour. Acta Paediatr Scand. 1987 Jul;76(4):566-72. — View Citation

Wiklund I, Norman M, Uvnäs-Moberg K, Ransjö-Arvidson AB, Andolf E. Epidural analgesia: breast-feeding success and related factors. Midwifery. 2009 Apr;25(2):e31-8. Epub 2007 Nov 5. — View Citation

Winslow JT, Insel TR. The social deficits of the oxytocin knockout mouse. Neuropeptides. 2002 Apr-Jun;36(2-3):221-9. Review. — View Citation

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.	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	No
Secondary	Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 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	No