NCT02727452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3.8 years

First QC Date

October 12, 2015

Last Update Submit

February 28, 2022

Conditions

C-Section

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Depression

    1-3 days and 6 weeks after childbirth

  • Mother-child-bonding

    1-3 days and 6 weeks after childbirth

  • Child's heart ratio

    30 and 60 minutes after birth

  • Child's oxygen saturation

    30 and 60 minutes after birth

  • Child's temperature

    30 and 60 minutes after birth

  • +1 more secondary outcomes

Study Arms (3)

immediate mother-skin-to-skin contact(SSC)

EXPERIMENTAL

The immediate mother-SSC begins directly after birth (still during the C-section)

Other: Skin-to-skin contact

immediate father-SSC

ACTIVE COMPARATOR

The immediate father-SSC begins directly after birth (still during C-section)

Other: Skin-to-skin contact

Routine care;mother-SSC after 30 minutes

OTHER

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

Interventions

Skin-to-skin contactOTHER
Routine care;mother-SSC after 30 minutesimmediate father-SSCimmediate mother-skin-to-skin contact(SSC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers with elective Caesarean Section and their partners

You may not qualify if:

  • premature birth
  • severe diseases
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine

Frankfurt am Main, Hesse, 60590, Germany

Location

Study Officials

  • Frank Louwen, Prof.

    University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.rer.nat.

Study Record Dates

First Submitted

October 12, 2015

First Posted

April 4, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 15, 2022

Record last verified: 2022-02

Locations

DE(1)