Early Skin-to-skin ContactSSCNCT01894880
Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section
A study testing early SSC and late SSC in people with Early Skin-to-skin Contact, run by Medical University of Graz at 1 site in Austria.
Trial summary
In the past decades frequency of cesarean section was increasing. Bonding or early skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery bonding/early SSC is already well-established. After cesarean section this important process starts after termination of operation. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Early Skin-to-skin Contact
- What is being tested?
- early SSC and late SSC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2013to Sep 2014
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18 years
- signed written informed consent
- single pregnancy
- elective cesarean section (between 7am and 15pm)
- Bleeding prophylaxis with Pabal® (carbetocin)
Who cannot join
- Age < 18 years
- disabled to give signed written informed consent
- Disease of mother or unborn, which could influence the study or makes the study impossible (e.g. severe malformation)
- Non elective cesarean
- Desire to wean
- Desire to leave the hospital within 6 hours after birth
- Bleeding prophylaxis with Syntocinon® (oxytocin)
Trial locations and contacts
1 site in 1 country.
About this study
In the past decades frequency of cesarean section was increasing. Bonding or early skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery bonding/early SSC is already well-established. After cesarean section this important process starts after termination of operation. A Cochran review analyzed randomized studies and shows positive effects of early SSC. Possible concerns to adopt bonding in the operating room are beside organizational ones (change of established processes) also a different ambiance in the operating room (temperature, light, noise). In a prospective randomized trial, early SSC after cesarean section should be analyzed.
Hypothesis
Mothers, who have the chance to bond immediately after birth in the operating room, have lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels. Adaptation of the newborn is within the normal range. Early bonding has a further positive effect on breast feeding, maternal pain processing and mental health.
- Conditions
- Early Skin-to-skin Contact
- Being tested
- early SSC, late SSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early SSCProcedure or surgery
bonding straight after birth
late SSCProcedure or surgery
bonding after termination of operation
| Study group | Role | What they receive |
|---|---|---|
| early SSC | Active comparator | Early SSC: bonding straight after birth Receives: Procedure: early SSC |
| late SSC | Other | late SSC: bonding after termination of operation Receives: Procedure: late SSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of oxytocin level
Measured: before, 0 min and 25 minutes after birth
Secondary outcomes (3)
Change of cortisol level
Measured: before, 0 min and 25 min after birth
Change of alpha Amylase level
Measured: before, 0 min and 25 min after birth
Change of chromogranin A level
Measured: before, 0 min and 25 min after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Skin-to-skin ContactStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martina Kollmann, MD, Principal investigator, Medical University of GrazPhilipp Klaritsch, MD, Study chair, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894880
- Sponsor's protocol ID
- 25-425ex12/13
- Acronym
- SSC
- Status last verified
- Apr 2015
- First submitted
- 25 Jun 2013
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.
PubMed 28231274
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section
- ClinicalTrials.gov ID
- NCT01894880
- Acronym / sponsor ID
- SSC / 25-425ex12/13
- Conditions
- Early Skin-to-skin Contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jul 2013 (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.
In the past decades frequency of cesarean section was increasing. Bonding or early skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery bonding/early SSC is already well-established. After cesarean section this important process starts after termination of operation. A Cochran review analyzed randomized studies and shows positive effects of early SSC. Possible concerns to adopt bonding in the operating room are beside organizational ones (change of established processes) also a different ambiance in the operating room (temperature, light, noise). In a prospective randomized trial, early SSC after cesarean section should be analyzed.
Hypothesis
Mothers, who have the chance to bond immediately after birth in the operating room, have lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels. Adaptation of the newborn is within the normal range. Early bonding has a further positive effect on breast feeding, maternal pain processing and mental health.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early SSC | Active comparator | Procedure: early SSCEarly SSC: bonding straight after birth |
| late SSC | Other | Procedure: late SSClate SSC: bonding after termination of operation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age > 18 years
- signed written informed consent
- single pregnancy
- elective cesarean section (between 7am and 15pm)
- Bleeding prophylaxis with Pabal® (carbetocin)
Key exclusion criteria (7 listed)
- Age < 18 years
- disabled to give signed written informed consent
- Disease of mother or unborn, which could influence the study or makes the study impossible (e.g. severe malformation)
- Non elective cesarean
- Desire to wean
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 |
|---|---|---|
| early SSCbonding straight after birth | Procedure or surgery | early SSC |
| late SSCbonding after termination of operation | Procedure or surgery | late SSC |
Primary outcome
Change of oxytocin level
Time frame: before, 0 min and 25 minutes after birth
3 secondary outcomes
Change of cortisol level
Time frame: before, 0 min and 25 min after birth
Change of alpha Amylase level
Time frame: before, 0 min and 25 min after birth
Change of chromogranin A level
Time frame: before, 0 min and 25 min 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 22 Apr 2015.
- Derived from this study: PubMed 28231274Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.
Related trials for Early Skin-to-skin Contact
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Enrolling by invitation
The Effect of Skin-to-Skin Contact Applied in the Early Postpartum Period on Maternal Pain, Birth Satisfaction, and Maternal Vital Signs Dynamics
Maternal Vital Signs, Skin-to-skin Contact
Recruiting
Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
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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.
Martina Kollmann, MD principal investigator
Medical University of Graz
Philipp Klaritsch, MD study chair
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early SSC and late SSC in people with Early Skin-to-skin Contact, run by Medical University of Graz at 1 site in Austria.
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 5 inclusion and 7 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 22 Apr 2015. 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 Austria. 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?
Change of oxytocin level (time frame: before, 0 min and 25 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894880, which also lists 1 linked publication.
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 22 Apr 2015.