Parents' Expectations and Experiences Around Cesarean Section in Belgium

Cesarean Section Clinical Trial

Official title:

Parents' Expectations and Experiences Around Cesarean Section in Belgium

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02609217
• Other study ID #: 58593
• Status: Active, not recruiting
• Phase: N/A
• First received: November 10, 2015
• Last updated: April 7, 2016
• Start date: November 2015

Study information

• Verified date: April 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of this study is to gain insight in the experiences and expectations of Belgian parents concerning primary cesarean section. This will be achieved by structured patient interviews and questionnaires in 24 women undergoing the procedure and their partners. This group will be divided into two subgroups of 12 multiparous and 12 nulliparous women and their partners.

Description:

The subjects in both groups will be interviewed twice and will receive three questionnaires. One to two weeks prior to the scheduled cesarean section and during a scheduled obstetric outpatient visit, the first interview and questionnaire will be administered to the couple. A second questionnaire will be provided while still hospitalized (5 days post partum), to both mother and partner. Six weeks post partum, during a scheduled obstetric outpatient visit, the couple will be interviewed for the last time and will be asked to complete the third and last questionnaire.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women

• Partner available

• 18-50 years of age

• Singleton pregnancy

• Booked for planned cesarean section =37 weeks of gestation

• Dutch-speaking

• Informed consent given

Exclusion Criteria:

• Emergency cesarean section

• <18 years of age or >50 years of age

• Multiple pregnancy

• Inability to provide consent (language, etc.)

• Partner not consenting

• BMI >35 kg/m2

• Maternal or fetal pathologies expected to affect pre and postnatal maternal/neonatal management

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Other:
• Questionnaires and interviews

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Information on parents' fears and expectations around cesarean section	Information on parents' fears and expectations around cesarean section will be obtained using structured patient interviews and questionnaires.	6 weeks post partum	No
Secondary	Quantitative data on postoperative pain after cesarean section	Quantitative data on postoperative pain after cesarean section will be obtained using VAS (Visual Analogue Scale) pain scores.	6 weeks post partum	No
Secondary	Data on the experience of postoperative pain after cesarean section	Data on the experience of postoperative pain after cesarean section will be obtained by content analysis of structured interviews.	6 weeks postpartum	No
Secondary	Data on frequency of breastfeeding after cesarean section	Frequency of breastfeeding after cesarean section will be described by number of breastfeeds per 24h.	6 weeks postpartum	No
Secondary	Qualitative data of breastfeeding after cesarean section	Data on quality of breastfeeding after cesarean section will be obtained using LATCH breastfeeding scores.	6 weeks postpartum	No
Secondary	Data on the experience of breastfeeding after cesarean section	Data on the experience of breastfeeding after cesarean section will be obtained by content analysis of structured interviews.	6 weeks postpartum	No