Immediate Bonding and Caesarean Section

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02727452
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 45
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The randomised study analyzes the effects of immediate bonding (skin-to-skin contact) on different psychobiological and somatic outcomes of mother and child. The investigators compare 3 bonding conditions. Cortisol and Oxytocin are also measured during the bonding process.

Condition or Disease	Intervention/Treatment	Phase
C-Section	Other: Skin-to-skin contact	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effects of Immediate Bonding (Skin-to-skin Contact) During Caesarean Section- Psychobiological and Somatic Outcomes of Mother and Child
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: immediate mother-skin-to-skin contact(SSC) The immediate mother-SSC begins directly after birth (still during the C-section)	Other: Skin-to-skin contact
Active Comparator: immediate father-SSC The immediate father-SSC begins directly after birth (still during C-section)	Other: Skin-to-skin contact
Other: Routine care;mother-SSC after 30 minutes After birth (still during C-section) the newborn gets routine care of a midwife close to the mother. SSC with mother after 30 minutes	Other: Skin-to-skin contact

Outcome Measures

Primary Outcome Measures

1. Changes in Cortisol Level [30 and 60 minutes after bonding]

   Cortisol is assessed as a stress parameter by Saliva. It will be tested in the mother and child to measure the effect of immediate bonding with the mother compared to the other 2 conditions on the stress level

Secondary Outcome Measures

1. Depression [1-3 days and 6 weeks after childbirth]

   assessed by EPDS

2. Mother-child-bonding [1-3 days and 6 weeks after childbirth]

   assessed by PBQ

3. Child's heart ratio [30 and 60 minutes after birth]

4. Child's oxygen saturation [30 and 60 minutes after birth]

5. Child's temperature [30 and 60 minutes after birth]

6. Oxytocin [30 and 60 minutes after birth]

   Saliva measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Mothers with elective Caesarean Section and their partners

Exclusion Criteria:

• premature birth

• severe diseases

• drug abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine	Frankfurt	Hessen	Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

• Study Director: Frank Louwen, Prof., University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Silvia Oddo, Dr.rer.nat., Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT02727452
• Other Study ID Numbers: E 9/15
• First Posted: Apr 4, 2016
• Last Update Posted: Mar 15, 2022
• Last Verified: Feb 1, 2022

Study Results

No Results Posted as of Mar 15, 2022