Parents' Expectations and Experiences Around Cesarean Section in Belgium

April 7, 2016 updated by: prof. dr. Tim Van Mieghem, Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women planned to undergo term elective cesarean section selected from antenatal low-risk clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiparous
12 multiparous women and their partners, planned to undergo elective term cesarean section.
Other: Questionnaires and interviews
Nulliparous
12 nulliparous women and their partners, planned to undergo elective term cesarean section.
Other: Questionnaires and interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Information on parents' fears and expectations around cesarean section
Time Frame: 6 weeks post partum
Information on parents' fears and expectations around cesarean section will be obtained using structured patient interviews and questionnaires.
6 weeks post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative data on postoperative pain after cesarean section
Time Frame: 6 weeks post partum
Quantitative data on postoperative pain after cesarean section will be obtained using VAS (Visual Analogue Scale) pain scores.
6 weeks post partum
Data on the experience of postoperative pain after cesarean section
Time Frame: 6 weeks postpartum
Data on the experience of postoperative pain after cesarean section will be obtained by content analysis of structured interviews.
6 weeks postpartum
Data on frequency of breastfeeding after cesarean section
Time Frame: 6 weeks postpartum
Frequency of breastfeeding after cesarean section will be described by number of breastfeeds per 24h.
6 weeks postpartum
Qualitative data of breastfeeding after cesarean section
Time Frame: 6 weeks postpartum
Data on quality of breastfeeding after cesarean section will be obtained using LATCH breastfeeding scores.
6 weeks postpartum
Data on the experience of breastfeeding after cesarean section
Time Frame: 6 weeks postpartum
Data on the experience of breastfeeding after cesarean section will be obtained by content analysis of structured interviews.
6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 58593

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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