Clinical trial NCT01894880: Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section
Official title: Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Skin-to-skin Contact
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change of oxytocin level
timeFrame: before, 0 min and 25 minutes after birth
Secondary outcomes:
measure: Change of cortisol level
timeFrame: before, 0 min and 25 min after birth
measure: Change of alpha Amylase level
timeFrame: before, 0 min and 25 min after birth
measure: Change of chromogranin A level
timeFrame: before, 0 min and 25 min after birth
Other outcomes:
measure: Change of pain scores on the Visual Analog Scale (VAS)
timeFrame: day 1 and 2 after birth
measure: Post natal Depression (edinburgh post natal Depression scale)
timeFrame: day 4 after birth
measure: Post natal Depression (edinburgh post natal Depression scale)
timeFrame: 6 weeks after birth
measure: Bonding behaviour (Postpartum Bonding Questionnaire )
timeFrame: day 4 after birth
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Martina Kollmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: Philipp Klaritsch, MD
role: STUDY_CHAIR
References:
citation: 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.