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

M

Medical University of Graz

Status

Completed

Conditions

Early Skin-to-skin Contact

Treatments

Procedure: late SSC
Procedure: early SSC

Study type

Interventional

Funder types

Other

Identifiers

NCT01894880
25-425ex12/13

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

early SSC
Active Comparator group
Description:
Early SSC: bonding straight after birth
Treatment:
Procedure: early SSC
late SSC
Other group
Description:
late SSC: bonding after termination of operation
Treatment:
Procedure: late SSC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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