To evaluate and obtain insight into psychological, social and moral factors in thoughts and attitudes of pregnant women and their partners carrying a fetus with an isolated CL ± P in order to improve counseling.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders congenital
- Abortions and stillbirth
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychological, social and moral factors in thoughts and attitudes of pregnant
women and their partners carrying a fetus with an isolated CL ± P .
Secondary outcome
• To describe parental interpretation of CL ± P (is it a threat, disability,
disease or a handicap) of CL, and whether they interpret this condition
as severe or not severe.
• To describe the influences from external contact (partner/family and
friends/professionals) on parental thoughts and attitude.
Background summary
Ultrasound (US) screening for cleft lip (CL) and cleft palate (CP) at 20-weeks
of pregnancy was introduced by practice in 2007, and at present more than 90%
of Dutch pregnant women use this opportunity. The counseling process of future
parents who are confronted with a prenatal diagnosis of orofacial cleft is in
it*s infancy. It would be valuable to analyse if there is a need for
improvement. The counseling process is never analysed before.
Study objective
To evaluate and obtain insight into psychological, social and moral factors in
thoughts and attitudes of pregnant women and their partners carrying a fetus
with an isolated CL ± P in order to improve counseling.
Study design
A Cross Sectional Quantitative Survey will be performed, with questionnaires.
Study burden and risks
There are no specific risks or benefits for the participants, although the
matter of the questions can be emotionally aggravating. For the latter parents
can ask counseling of a medical psychologist. The filling out of the
questionnaires will take approximately 30 minutes of their time and can be done
at home. The participants will remain anonymously.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
1. Pregnant women and their partners
2. Age: >= 18 years
3. Referred to Department of Obstetrics and Gynaecology Wilhelmina Childrens*s Hospital,
Utrecht
4. Isolated CL ± P is detected on US
5. Before 24 weeks* gestation
Exclusion criteria
1. Associated anomalies detected on ultrasound.
2. Median cleft
3. Pregnant women and thier with a psychiatric disease or other conditions making them incapable of filling out the questionnaire.
4. Pregnant women and their partners incapable of filling out the questionnaire because of a language barrier.
5. Participants who do not filling out the required percentage for relevant inventory, which is 99%.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27986.041.09 |