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

Early Skin-to-skin Contact Clinical Trial

— SSC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894880
• Other study ID #: 25-425ex12/13
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: April 21, 2015
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Early Skin-to-skin Contact

Intervention

Procedure:
• early SSC
bonding straight after birth
• late SSC
bonding after termination of operation

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of pain scores on the Visual Analog Scale (VAS)		day 1 and 2 after birth	No
Other	Post natal Depression (edinburgh post natal Depression scale)		day 4 after birth	No
Other	Post natal Depression (edinburgh post natal Depression scale)		6 weeks after birth	No
Other	Bonding behaviour (Postpartum Bonding Questionnaire )		day 4 after birth	No
Primary	Change of oxytocin level		before, 0 min and 25 minutes after birth	No
Secondary	Change of cortisol level		before, 0 min and 25 min after birth	No
Secondary	Change of alpha Amylase level		before, 0 min and 25 min after birth	No
Secondary	Change of chromogranin A level		before, 0 min and 25 min after birth	No