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Completed

NCT Number: NCT02727452

Immediate Bonding and Caesarean Section

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.

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Key information

Conditions

C-Section

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mothers with elective Caesarean Section and their partners

Exclusion criteria

  • premature birth
  • severe diseases
  • drug abuse

Treatment and study plan

Skin-to-skin contact

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Depression

    Time frame: 1-3 days and 6 weeks after childbirth

    assessed by EPDS

  2. Mother-child-bonding

    Time frame: 1-3 days and 6 weeks after childbirth

    assessed by PBQ

  3. Child's heart ratio

    Time frame: 30 and 60 minutes after birth

  4. Child's oxygen saturation

    Time frame: 30 and 60 minutes after birth

  5. Child's temperature

    Time frame: 30 and 60 minutes after birth

  6. Oxytocin

    Time frame: 30 and 60 minutes after birth

    Saliva measurement

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2016
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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