No registrations found.
ID
Source
Brief title
Health condition
Pelvic floor,
pelvic organ prolapse,
genetic polymorphism,
collagen
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of the COL3A1 polymorphism in first and second degree family members of the index patients with the homozygous COL3A1 polymorphism.
Secondary outcome
The presence of pelvic organ prolapse and related conditions (such as inguinal hernia) in first and second degree family members of the index patients with the homozygous COL3A1 polymorphism.
Background summary
Type III collagen is of special importance in tissue repair following mechanical stretch such as in delivery or pelvic organ prolapse (POP). Type III collagen polymorphisms may therefore result in a decrease in tissue repair and may lead to impaired tensile strength of ligaments and supportive tissues. Chen and co-workers have suggested that a COL3A1 polymorphism in exon 30 was related to POP in Taiwanese women. Our research group recently confirmed this finding in a larger population of 202 Dutch POP patients and 102 parous controls. The odds ratio for the presence of POP in a woman with this homozygous COL3A1 polymorphism is 5.0 (95% confidence interval 1.4; 17.1).
Our hypothesis is that the COL3A1 polymorphism is a inheritable genetic defect, responsible for increased familial susceptibility to pelvic organ prolapse and other collagen-mediated diseases.
Study objective
The COL3A1 polymorphism is a inheritable genetic defect, responsible for the increased susceptibility to pelvic organ prolapse in women.
Study design
1. A blood sample of all subjects will be used for the detection of the COL3A1 polymorphism by means of PCR followed by RFLP analysis;
2. Prolapse will be assessed by gynaecological investigation of female subjects to complete the POP-Q;
3. Other related conditions will be evaluated by means of a qestionnaire.
Intervention
None.
S.L. Lince
Universitair Medisch Centrum St. Radboud, Afdeling Verloskunde en Gynaecologie. Huispost 791. Postbus 9101
Nijmegen 3500 HB
The Netherlands
+31 (0)24-3614726
S.Lince@obgyn.umcn.nl.
S.L. Lince
Universitair Medisch Centrum St. Radboud, Afdeling Verloskunde en Gynaecologie. Huispost 791. Postbus 9101
Nijmegen 3500 HB
The Netherlands
+31 (0)24-3614726
S.Lince@obgyn.umcn.nl.
Inclusion criteria
First and second degree relatives of patients with COL3A1 polymorphism.
Exclusion criteria
1. Genetic diseases with a known increased risk of POP (such as Ehlers Danlos, Marfan and Steinert’s disease);
2. Problems with regards to the patient’s understanding of the study;
3. Age < 18 years.
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 |
|---|---|
| NTR-new | NL1825 |
| NTR-old | NTR1935 |
| Other | CMO Regio Arnhem-Nijmegen : 2009/067 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |