Immediate Bonding and Caesarean Section

Not Applicable

Completed

• Conditions: C-Section
• Interventions: Other: Skin-to-skin contact

• Registration Number: NCT02727452
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-12
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Mothers with elective Caesarean Section and their partners

Exclusion Criteria

• premature birth
• severe diseases
• drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Routine care;mother-SSC after 30 minutes	Skin-to-skin contact	After birth (still during C-section) the newborn gets routine care of a midwife close to the mother. SSC with mother after 30 minutes
immediate mother-skin-to-skin contact(SSC)	Skin-to-skin contact	The immediate mother-SSC begins directly after birth (still during the C-section)
immediate father-SSC	Skin-to-skin contact	The immediate father-SSC begins directly after birth (still during C-section)

Primary Outcome Measures

Name	Time	Method
Changes in Cortisol Level	30 and 60 minutes after bonding	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

Secondary Outcome Measures

Name	Time	Method
Depression	1-3 days and 6 weeks after childbirth	assessed by EPDS
Child's oxygen saturation	30 and 60 minutes after birth
Child's temperature	30 and 60 minutes after birth
Child's heart ratio	30 and 60 minutes after birth
Oxytocin	30 and 60 minutes after birth	Saliva measurement
Mother-child-bonding	1-3 days and 6 weeks after childbirth	assessed by PBQ

Trial Locations

Locations (1)

University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine; 🇩🇪 Frankfurt, Hessen, Germany