Delivery, Obstetric
Conditions
Brief summary
Single-nucleotide polymorphisms (SNP's) in connective tissue components are associated with increased risk of pelvic organ prolapse (POP). The investigators expect to find a difference in SNP's frequency between women who had Obstetric anal sphincter injuries (OASIS) and in the healthy population. The fact that pelvic organ prolapse (POP) and OASIS occurs in the same anatomic region and the well-known association between few SNP's and the risk for POP, suggests for a common pathophysiology.
Detailed description
The perineum consists of skin, muscles and connective tissue. A connective tissue disorder related to POP has been reported in biochemical and molecular studies. OASIS are considered a severe complication of vaginal delivery that may lead to a great deal of morbidity. Familial history is known as a risk factor for OASIS. Currently, there is no established genetic link between connective tissue components and OASIS. Therefore, the investigators assume that studying the genetic predisposition factors of women who experience OASIS, might generate a stronger tool to predict severe occurrence of vaginal laceration. It may also help to consult women before vaginal delivery about the risk of OASIS. The aim of this study is to find an association between genetic variation and increased risk for OASIS.
Interventions
GENETICscreening for single nucleotide polymorphism
samples from both arms will be tested for a set of single nucleotide polymorphism
GENETICwhole exome sequencing
samples from arm #1 (women with external anal sphincter) will be tested for identifying specific genetic mutation
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
two arms - 1. with external anal sphincter injury 2. without injury both will go through genetic screening test the arm with the external anal sphincter injury will also be tested for advanced genetic testing
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with severe external anal sphincter injury during first vaginal delivery * Healthy women undergoing vaginal delivery without any clinically apparent perineal laceration
Exclusion criteria
* Women with known metabolic or connective-tissue disorder (e.g., Ehlers-Danlos syndrome). * Women with known neurologic disorder * Women undergoing episiotomy cut or assisted delivery (e.g., vacuum or forceps delivery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in the frequency of of Single-nucleotide polymorphisms | through study completion, an average of 2 years | difference in the relative frequency of Single-nucleotide polymorphisms between women with external anal sphincter injury that occurs during vaginal delivery and those without it. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| genetic mutation | through study completion, an average of 2 years | specific genetic mutation among women with external anal sphincter injury that occurs during vaginal delivery |
Countries
Israel
Outcome results
None listed