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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01894880
First received: June 25, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Early Skin-to-skin Contact
Procedure: early SSC
Procedure: late SSC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Change of oxytocin level [ Time Frame: before, 0 min and 25 minutes after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of cortisol level [ Time Frame: before, 0 min and 25 min after birth ] [ Designated as safety issue: No ]
  • Change of alpha Amylase level [ Time Frame: before, 0 min and 25 min after birth ] [ Designated as safety issue: No ]
  • Change of chromogranin A level [ Time Frame: before, 0 min and 25 min after birth ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change of pain scores on the Visual Analog Scale (VAS) [ Time Frame: day 1 and 2 after birth ] [ Designated as safety issue: No ]
  • Post natal Depression (edinburgh post natal Depression scale) [ Time Frame: day 4 after birth ] [ Designated as safety issue: No ]
  • Post natal Depression (edinburgh post natal Depression scale) [ Time Frame: 6 weeks after birth ] [ Designated as safety issue: No ]
  • Bonding behaviour (Postpartum Bonding Questionnaire ) [ Time Frame: day 4 after birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: early SSC
Early SSC: bonding straight after birth
Procedure: early SSC
bonding straight after birth
late SSC
late SSC: bonding after termination of operation
Procedure: late SSC
bonding after termination of operation

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894880

Contacts
Contact: Martina Kollmann, MD 0043 316 385 ext 84190 martina.kollmann@medunigraz.at
Contact: Philipp Klaritsch, MD 0043 316 385 ext 81641 philipp.klaritsch@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Martina Kollmann, MD    0043 316 385 ext 84190    martina.kollmann@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Martina Kollmann, MD Medical University of Graz
Study Chair: Philipp Klaritsch, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01894880     History of Changes
Other Study ID Numbers: 25-425ex12/13
Study First Received: June 25, 2013
Last Updated: April 3, 2014
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on September 16, 2014