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Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section (SSC)

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ClinicalTrials.gov Identifier: NCT01894880
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

June 25, 2013
July 10, 2013
April 22, 2015
July 2013
September 2014   (Final data collection date for primary outcome measure)
Change of oxytocin level [ Time Frame: before, 0 min and 25 minutes after birth ]
Same as current
Complete list of historical versions of study NCT01894880 on ClinicalTrials.gov Archive Site
  • Change of cortisol level [ Time Frame: before, 0 min and 25 min after birth ]
  • Change of alpha Amylase level [ Time Frame: before, 0 min and 25 min after birth ]
  • Change of chromogranin A level [ Time Frame: before, 0 min and 25 min after birth ]
Same as current
  • Change of pain scores on the Visual Analog Scale (VAS) [ Time Frame: day 1 and 2 after birth ]
  • Post natal Depression (edinburgh post natal Depression scale) [ Time Frame: day 4 after birth ]
  • Post natal Depression (edinburgh post natal Depression scale) [ Time Frame: 6 weeks after birth ]
  • Bonding behaviour (Postpartum Bonding Questionnaire ) [ Time Frame: day 4 after birth ]
Same as current
 
Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section
Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

In the past decades frequency of cesarean section was increasing. Bonding or early skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery bonding/early SSC is already well-established. After cesarean section this important process starts after termination of operation. A Cochran review analyzed randomized studies and shows positive effects of early SSC. Possible concerns to adopt bonding in the operating room are beside organizational ones (change of established processes) also a different ambiance in the operating room (temperature, light, noise). In a prospective randomized trial, early SSC after cesarean section should be analyzed.

Hypothesis

Mothers, who have the chance to bond immediately after birth in the operating room, have lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels. Adaptation of the newborn is within the normal range. Early bonding has a further positive effect on breast feeding, maternal pain processing and mental health.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Early Skin-to-skin Contact
  • Procedure: early SSC
    bonding straight after birth
  • Procedure: late SSC
    bonding after termination of operation
  • Active Comparator: early SSC
    Early SSC: bonding straight after birth
    Intervention: Procedure: early SSC
  • late SSC
    late SSC: bonding after termination of operation
    Intervention: Procedure: late SSC
Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
30
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • signed written informed consent
  • single pregnancy
  • elective cesarean section (between 7am and 15pm)
  • Bleeding prophylaxis with Pabal® (carbetocin)

Exclusion Criteria:

  • Age < 18 years
  • disabled to give signed written informed consent
  • Disease of mother or unborn, which could influence the study or makes the study impossible (e.g. severe malformation)
  • Non elective cesarean
  • Desire to wean
  • Desire to leave the hospital within 6 hours after birth
  • Bleeding prophylaxis with Syntocinon® (oxytocin)
Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01894880
25-425ex12/13
No
Not Provided
Not Provided
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Martina Kollmann, MD Medical University of Graz
Study Chair: Philipp Klaritsch, MD Medical University of Graz
Medical University of Graz
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP