Cesarean SectionNCT02609217
Parents' Expectations and Experiences Around Cesarean Section in Belgium
An observational study of Cesarean Section, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Questionnaires and interviews
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2015to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women planned to undergo term elective cesarean section selected from antenatal low-risk clinic.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cesarean Section
- Being tested
- Questionnaires and interviews
- Keywords
- elective, cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and interviewsOther
| Study group | Role | What they receive |
|---|---|---|
| Multiparous | 12 multiparous women and their partners, planned to undergo elective term cesarean section. Receives: Other: Questionnaires and interviews | |
| Nulliparous | 12 nulliparous women and their partners, planned to undergo elective term cesarean section. Receives: Other: Questionnaires and interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post partum
Secondary outcomes (5)
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.
Measured: 6 weeks post partum
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.
Measured: 6 weeks postpartum
Data on frequency of breastfeeding after cesarean section
Frequency of breastfeeding after cesarean section will be described by number of breastfeeds per 24h.
Measured: 6 weeks postpartum
Qualitative data of breastfeeding after cesarean section
Data on quality of breastfeeding after cesarean section will be obtained using LATCH breastfeeding scores.
Measured: 6 weeks postpartum
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.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Tim Van Mieghem, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609217
- Sponsor's protocol ID
- 58593
- Status last verified
- Apr 2016
- First submitted
- 10 Nov 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Expectations and Experiences Around Cesarean Section in Belgium
- ClinicalTrials.gov ID
- NCT02609217
- Acronym / sponsor ID
- 58593
- Conditions
- Cesarean Section
- Keywords
- elective, cesarean
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiparous | – | Other: Questionnaires and interviews12 multiparous women and their partners, planned to undergo elective term cesarean section. |
| Nulliparous | – | Other: Questionnaires and interviews12 nulliparous women and their partners, planned to undergo elective term cesarean section. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women planned to undergo term elective cesarean section selected from antenatal low-risk clinic.
Key inclusion criteria (7 listed)
- Pregnant women
- Partner available
- 18-50 years of age
- Singleton pregnancy
- Booked for planned cesarean section ≥37 weeks of gestation
Key exclusion criteria (7 listed)
- Emergency cesarean section
- <18 years of age or >50 years of age
- Multiple pregnancy
- Inability to provide consent (language, etc.)
- Partner not consenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and interviews | Other | Multiparous, Nulliparous |
Primary outcome
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.
5 secondary outcomes
Quantitative data on postoperative pain after cesarean section
Time frame: 6 weeks post partum
Data on the experience of postoperative pain after cesarean section
Time frame: 6 weeks postpartum
Data on frequency of breastfeeding after cesarean section
Time frame: 6 weeks postpartum
Qualitative data of breastfeeding after cesarean section
Time frame: 6 weeks postpartum
Data on the experience of breastfeeding after cesarean section
Time frame: 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information on parents' fears and expectations around cesarean section (time frame: 6 weeks post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.