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

Not Applicable

Completed

• Conditions: Early Skin-to-skin Contact
• Interventions: Procedure: early SSC; Procedure: late SSC

• Registration Number: NCT01894880
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-25
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early SSC	early SSC	Early SSC: bonding straight after birth
late SSC	late SSC	late SSC: bonding after termination of operation

Primary Outcome Measures

Name	Time	Method
Change of oxytocin level	before, 0 min and 25 minutes after birth

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria