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

This study has been completed.
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: June 25, 2013
Last updated: April 21, 2015
Last verified: April 2015

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.


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.

Condition Intervention
Early Skin-to-skin Contact
Procedure: early SSC
Procedure: late SSC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

Resource links provided by NLM:

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Change of oxytocin level [ Time Frame: before, 0 min and 25 minutes after birth ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 35
Study Start Date: July 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: early SSC
Early SSC: bonding straight after birth
Procedure: early SSC
bonding straight after birth
late SSC
late SSC: bonding after termination of operation
Procedure: late SSC
bonding after termination of operation


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01894880

Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Martina Kollmann, MD Medical University of Graz
Study Chair: Philipp Klaritsch, MD Medical University of Graz
  More Information

Responsible Party: Medical University of Graz Identifier: NCT01894880     History of Changes
Other Study ID Numbers: 25-425ex12/13
Study First Received: June 25, 2013
Last Updated: April 21, 2015 processed this record on May 23, 2017