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

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.

Study Overview

• Status: Completed
• Conditions: Early Skin-to-skin Contact
• Intervention / Treatment: Procedure: early SSC; Procedure: late SSC

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: early SSC; Early SSC: bonding straight after birth	Procedure: early SSC; bonding straight after birth
Other: late SSC; late SSC: bonding after termination of operation	Procedure: late SSC; bonding after termination of operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of oxytocin level	before, 0 min and 25 minutes after birth

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
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
Bonding behaviour (Postpartum Bonding Questionnaire )	day 4 after birth

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Martina Kollmann, MD, Medical University of Graz; Study Chair: Philipp Klaritsch, MD, Medical University of Graz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: July 4, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 25-425ex12/13