Immediate Bonding and Caesarean Section

NCT ID: NCT02727452

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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C-Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Skin-to-skin contact

Intervention Type OTHER

immediate father-SSC

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

Group Type ACTIVE_COMPARATOR

Skin-to-skin contact

Intervention Type 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

Group Type OTHER

Skin-to-skin contact

Intervention Type OTHER

Interventions

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Skin-to-skin contact

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Mothers with elective Caesarean Section and their partners

Exclusion Criteria

* premature birth
* severe diseases
* drug abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Silvia Oddo

Dr.rer.nat.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Louwen, Prof.

Role: STUDY_DIRECTOR

University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine

Locations

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University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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E 9/15

Identifier Type: -

Identifier Source: org_study_id

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