Immediate Bonding and Caesarean Section

C-Section Clinical Trial

Official title:

Effects of Immediate Bonding (Skin-to-skin Contact) During Caesarean Section- Psychobiological and Somatic Outcomes of Mother and Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727452
• Other study ID #: E 9/15
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2022
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The randomised study analyzes the effects of immediate bonding (skin-to-skin contact) on different psychobiological and somatic outcomes of mother and child. The investigators compare 3 bonding conditions. Cortisol and Oxytocin are also measured during the bonding process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mothers with elective Caesarean Section and their partners

Exclusion Criteria:

• premature birth
• severe diseases
• drug abuse

Related Conditions & MeSH terms

• C-Section

Intervention

Other:
• Skin-to-skin contact

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cortisol Level	Cortisol is assessed as a stress parameter by Saliva. It will be tested in the mother and child to measure the effect of immediate bonding with the mother compared to the other 2 conditions on the stress level	30 and 60 minutes after bonding
Secondary	Depression	assessed by EPDS	1-3 days and 6 weeks after childbirth
Secondary	Mother-child-bonding	assessed by PBQ	1-3 days and 6 weeks after childbirth
Secondary	Child's heart ratio		30 and 60 minutes after birth
Secondary	Child's oxygen saturation		30 and 60 minutes after birth
Secondary	Child's temperature		30 and 60 minutes after birth
Secondary	Oxytocin	Saliva measurement	30 and 60 minutes after birth