NCT01894880|Completed
Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section
SSC
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SSC
Sponsor study identifier
interventional
35
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2013
Actual (reported)July 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 10, 2013
Actual (reported)September 2014
Actual (reported)September 2014
Actual (reported)Change of oxytocin level
before, 0 min and 25 minutes after birth
Change of cortisol level
before, 0 min and 25 min after birth
Change of alpha Amylase level
before, 0 min and 25 min after birth
Change of chromogranin A level
before, 0 min and 25 min after birth
Change of pain scores on the Visual Analog Scale (VAS)
day 1 and 2 after birth
Post natal Depression (edinburgh post natal Depression scale)
day 4 after birth
Post natal Depression (edinburgh post natal Depression scale)
6 weeks after birth
Early SSC: bonding straight after birth
late SSC: bonding after termination of operation
bonding straight after birth
bonding after termination of operation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medical University of Graz
Graz, Graz, 8036, Austria
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.
Martina Kollmann, MD
Medical University of Graz
Philipp Klaritsch, MD
Medical University of Graz
35 participants (actual enrollment reported by the registry).
First Submitted
June 25, 2013
First Posted
July 10, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
April 22, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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