BondingNCT01891201
Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes
An observational study of Bonding and Oxytocin, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 1 day to 4 days
- Conditions the study is for
- Bonding, Oxytocin, Breastfeeding
- What is being tested?
- Oxytocin
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Jun 2013
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 4 days
- All sexes
- No healthy volunteers
- Child
Study population: Maternity ward of a terciary Hospital
Who may be able to join
- Healthy singleton term infant delivered vaginally with Apgar at 5 min> 7;
- Expressed desire to administer during pregnancy breastfeeding;
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Puerta de Hierro-Majadahonda
Madrid, Madrid, 28220
About this study
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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Comparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Not exposed to oxytocin | Mother-child dyads in which Oxt had not been administered during the birth process Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 72 hours
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for BondingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Angel Marin Gabriel, Puerta de Hierro University Hospital
- Investigators
- Miguel A Marín, MD, Principal investigator, Hospital Universitario Puerta de Hierro Majadahonda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891201
- Sponsor's protocol ID
- PI10/00791
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Carter CS, Williams JR, Witt DM, Insel TR. Oxytocin and social bonding. Ann N Y Acad Sci. 1992 Jun 12;652:204-11. doi: 10.1111/j.1749-6632.1992.tb34356.x.
PubMed 1626829Carter CS. Developmental consequences of oxytocin. Physiol Behav. 2003 Aug;79(3):383-97. doi: 10.1016/s0031-9384(03)00151-3.
PubMed 12954433Insel TR, Young LJ. The neurobiology of attachment. Nat Rev Neurosci. 2001 Feb;2(2):129-36. doi: 10.1038/35053579.
PubMed 11252992Baumgartner 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.
PubMed 18498743Ishak 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.
PubMed 20584551Bell 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.
PubMed 23084698Malek A, Blann E, Mattison DR. Human placental transport of oxytocin. J Matern Fetal Med. 1996 Sep-Oct;5(5):245-55. doi: 10.1002/(SICI)1520-6661(199609/10)5:53.0.CO;2-H.
PubMed 8930795Wahl 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. doi: 10.1016/j.mehy.2004.03.008.
PubMed 15288368Bales 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. doi: 10.1002/dev.20216.
PubMed 17455224Widstrom AM, Ransjo-Arvidson AB, Christensson K, Matthiesen AS, Winberg J, Uvnas-Moberg K. Gastric suction in healthy newborn infants. Effects on circulation and developing feeding behaviour. Acta Paediatr Scand. 1987 Jul;76(4):566-72. doi: 10.1111/j.1651-2227.1987.tb10522.x.
PubMed 3630673Righard L, Alade MO. Effect of delivery room routines on success of first breast-feed. Lancet. 1990 Nov 3;336(8723):1105-7. doi: 10.1016/0140-6736(90)92579-7.
PubMed 1977988Bu'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. doi: 10.1111/j.1469-8749.1990.tb08427.x.
PubMed 2210082Olza Fernandez I, Marin Gabriel M, Malalana Martinez A, Fernandez-Canadas Morillo A, Lopez Sanchez 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.
PubMed 22452314Hernandez Aguilar MT, Aguayo Maldonado J; Comite de Lactancia Materna de la Asociacion Espanola de Pediatria. [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. doi: 10.1157/13079817. No abstract available. Spanish.
PubMed 16219255Torvaldsen 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. doi: 10.1186/1746-4358-1-24.
PubMed 17134489
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes
- ClinicalTrials.gov ID
- NCT01891201
- Acronym / sponsor ID
- PI10/00791
- Conditions
- Bonding, Oxytocin, Breastfeeding, Newborn, Perinatal
- Keywords
- Bonding, Oxytocin, Breastfeeding, Newborn, Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not exposed to oxytocin | – | Drug: OxytocinMother-child dyads in which Oxt had not been administered during the birth process |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Maternity ward of a terciary Hospital
Key inclusion criteria (3 listed)
- Healthy singleton term infant delivered vaginally with Apgar at 5 min> 7;
- Expressed desire to administer during pregnancy breastfeeding;
- Signed informed consent
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinComparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin | Drug | Not exposed to oxytocin |
Primary outcome
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).
1 secondary outcome
Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 months.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Background: PubMed 1626829Carter CS, Williams JR, Witt DM, Insel TR. Oxytocin and social bonding. Ann N Y Acad Sci. 1992 Jun 12;652:204-11. doi: 10.1111/j.1749-6632.1992.tb34356.x.
- Background: PubMed 12954433Carter CS. Developmental consequences of oxytocin. Physiol Behav. 2003 Aug;79(3):383-97. doi: 10.1016/s0031-9384(03)00151-3.
- Background: PubMed 11252992Insel TR, Young LJ. The neurobiology of attachment. Nat Rev Neurosci. 2001 Feb;2(2):129-36. doi: 10.1038/35053579.
- Background: PubMed 18498743Baumgartner 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.
- Background: PubMed 20584551Ishak 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.
- Background: PubMed 23084698Bell 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.
- Background: PubMed 8930795Malek A, Blann E, Mattison DR. Human placental transport of oxytocin. J Matern Fetal Med. 1996 Sep-Oct;5(5):245-55. doi: 10.1002/(SICI)1520-6661(199609/10)5:53.0.CO;2-H.
- Background: PubMed 15288368Wahl 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. doi: 10.1016/j.mehy.2004.03.008.
- Background: PubMed 17455224Bales 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. doi: 10.1002/dev.20216.
- Background: PubMed 3630673Widstrom AM, Ransjo-Arvidson AB, Christensson K, Matthiesen AS, Winberg J, Uvnas-Moberg K. Gastric suction in healthy newborn infants. Effects on circulation and developing feeding behaviour. Acta Paediatr Scand. 1987 Jul;76(4):566-72. doi: 10.1111/j.1651-2227.1987.tb10522.x.
- Background: PubMed 1977988Righard L, Alade MO. Effect of delivery room routines on success of first breast-feed. Lancet. 1990 Nov 3;336(8723):1105-7. doi: 10.1016/0140-6736(90)92579-7.
- Background: PubMed 2210082Bu'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. doi: 10.1111/j.1469-8749.1990.tb08427.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel A Marín, MD principal investigator
Hospital Universitario Puerta de Hierro Majadahonda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bonding and Oxytocin, run by Puerta de Hierro University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891201, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.