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Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01894880
Acronym
SSC
Enrollment
35
Registered
2013-07-10
Start date
2013-07-31
Completion date
2014-09-30
Last updated
2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Skin-to-skin Contact

Brief 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. 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.

Interventions

PROCEDUREearly SSC

bonding straight after birth

PROCEDURElate SSC

bonding after termination of operation

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * signed written informed consent * single pregnancy * elective cesarean section (between 7am and 15pm) * Bleeding prophylaxis with Pabal® (carbetocin)

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
Change of oxytocin levelbefore, 0 min and 25 minutes after birth

Secondary

MeasureTime frame
Change of cortisol levelbefore, 0 min and 25 min after birth
Change of alpha Amylase levelbefore, 0 min and 25 min after birth
Change of chromogranin A levelbefore, 0 min and 25 min after birth

Other

MeasureTime frame
Post natal Depression (edinburgh post natal Depression scale)day 4 after birth
Bonding behaviour (Postpartum Bonding Questionnaire )day 4 after birth
Change of pain scores on the Visual Analog Scale (VAS)day 1 and 2 after birth

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026