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

NCT01894880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-04-22

No results posted yet for this study

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.

Conditions

  • Early Skin-to-skin Contact

Interventions

PROCEDURE

early SSC

bonding straight after birth

PROCEDURE

late SSC

bonding after termination of operation

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Martina Kollmann, MD · Medical University of Graz

  • Philipp Klaritsch, MD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01894880 on ClinicalTrials.gov