C-SectionNCT02727452
Immediate Bonding and Caesarean Section
A study testing Skin-to-skin contact in people with C-Section, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- C-Section
- What is being tested?
- Skin-to-skin contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers with elective Caesarean Section and their partners
Who cannot join
- premature birth
- severe diseases
- drug abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine
Frankfurt am Main, Hesse, 60590
About this study
Official title: 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.
- Conditions
- C-Section
- Being tested
- Skin-to-skin contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-skin contactOther
| Study group | Role | What they receive |
|---|---|---|
| immediate mother-skin-to-skin contact(SSC) | Experimental | The immediate mother-SSC begins directly after birth (still during the C-section) Receives: Other: Skin-to-skin contact |
| immediate father-SSC | Active comparator | The immediate father-SSC begins directly after birth (still during C-section) Receives: 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 Receives: Other: Skin-to-skin contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 and 60 minutes after bonding
Secondary outcomes (6)
Depression
assessed by EPDS
Measured: 1-3 days and 6 weeks after childbirth
Mother-child-bonding
assessed by PBQ
Measured: 1-3 days and 6 weeks after childbirth
Child's heart ratio
Measured: 30 and 60 minutes after birth
Child's oxygen saturation
Measured: 30 and 60 minutes after birth
Child's temperature
Measured: 30 and 60 minutes after birth
Oxytocin
Saliva measurement
Measured: 30 and 60 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C-SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Silvia Oddo, Johann Wolfgang Goethe University Hospital
- Investigators
- Frank Louwen, Prof., Study director, University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727452
- Sponsor's protocol ID
- E 9/15
- Status last verified
- Feb 2022
- First submitted
- 12 Oct 2015
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immediate Bonding (Skin-to-skin Contact) During Caesarean Section- Psychobiological and Somatic Outcomes of Mother and Child
- ClinicalTrials.gov ID
- NCT02727452
- Acronym / sponsor ID
- E 9/15
- Conditions
- C-Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| immediate mother-skin-to-skin contact(SSC) | Experimental | Other: Skin-to-skin contactThe immediate mother-SSC begins directly after birth (still during the C-section) |
| immediate father-SSC | Active comparator | Other: Skin-to-skin contactThe immediate father-SSC begins directly after birth (still during C-section) |
| Routine care;mother-SSC after 30 minutes | Other | Other: Skin-to-skin contactAfter birth (still during C-section) the newborn gets routine care of a midwife close to the mother. SSC with mother after 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers with elective Caesarean Section and their partners
Key exclusion criteria (3 listed)
- premature birth
- severe diseases
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin-to-skin contact | Other | Routine care;mother-SSC after 30 minutes, immediate father-SSC, immediate mother-skin-to-skin contact(SSC) |
Primary outcome
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
6 secondary outcomes
Depression
Time frame: 1-3 days and 6 weeks after childbirth
Mother-child-bonding
Time frame: 1-3 days and 6 weeks after childbirth
Child's heart ratio
Time frame: 30 and 60 minutes after birth
Child's oxygen saturation
Time frame: 30 and 60 minutes after birth
Child's temperature
Time frame: 30 and 60 minutes after birth
Oxytocin
Time frame: 30 and 60 minutes after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Louwen, Prof. study director
University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin-to-skin contact in people with C-Section, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cortisol Level (time frame: 30 and 60 minutes after bonding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.