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

Study Overview
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Brief Summary
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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.

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

Conditions
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Early Skin-to-skin Contact

Intervention / Treatment
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* Procedure: early SSC
* Procedure: late SSC


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early SSC<br>Early SSC: bonding straight after birth | Procedure: early SSC<br>* bonding straight after birth<br>|
| Other: late SSC<br>late SSC: bonding after termination of operation | Procedure: late SSC<br>* bonding after termination of operation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |