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Completed

NCT Number: NCT01894880

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

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.

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Key information

Conditions

Early Skin-to-skin Contact

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

early SSC

Procedure

bonding straight after birth

late SSC

Procedure

bonding after termination of operation

Primary outcomes

  1. Change of oxytocin level

    Time frame: before, 0 min and 25 minutes after birth

Secondary outcomes

  1. Change of cortisol level

    Time frame: before, 0 min and 25 min after birth

  2. Change of alpha Amylase level

    Time frame: before, 0 min and 25 min after birth

  3. Change of chromogranin A level

    Time frame: before, 0 min and 25 min after birth

Other outcomes

  1. Change of pain scores on the Visual Analog Scale (VAS)

    Time frame: day 1 and 2 after birth

  2. Post natal Depression (edinburgh post natal Depression scale)

    Time frame: day 4 after birth

  3. Post natal Depression (edinburgh post natal Depression scale)

    Time frame: 6 weeks after birth

  4. Bonding behaviour (Postpartum Bonding Questionnaire )

    Time frame: day 4 after birth

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: SSC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.