Immediate Bonding and Caesarean Section

February 28, 2022 updated by: Dr. Silvia Oddo, Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mothers with elective Caesarean Section and their partners

Exclusion Criteria:

  • premature birth
  • severe diseases
  • drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate mother-skin-to-skin contact(SSC)
The immediate mother-SSC begins directly after birth (still during the C-section)
Other: Skin-to-skin contact
Active Comparator: immediate father-SSC
The immediate father-SSC begins directly after birth (still during C-section)
Other: Skin-to-skin contact
Other: Routine care;mother-SSC after 30 minutes
After birth (still during C-section) the newborn gets routine care of a midwife close to the mother. SSC with mother after 30 minutes
Other: Skin-to-skin contact

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cortisol Level
Time Frame: 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
30 and 60 minutes after bonding

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Study Director: Frank Louwen, Prof., University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • E 9/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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