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Parents' Expectations and Experiences Around Cesarean Section in Belgium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609217
Recruitment Status : Unknown
Verified April 2016 by prof. dr. Tim Van Mieghem, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
prof. dr. Tim Van Mieghem, Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment
Cesarean Section Other: Questionnaires and interviews

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.

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parents' Expectations and Experiences Around Cesarean Section in Belgium
Study Start Date : November 2015
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women planned to undergo term elective cesarean section selected from antenatal low-risk clinic.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609217


Locations
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Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: prof. dr. Tim Van Mieghem, Assistant professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02609217    
Other Study ID Numbers: 58593
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Keywords provided by prof. dr. Tim Van Mieghem, Universitaire Ziekenhuizen Leuven:
elective
cesarean