The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: women with external anal sphincter injury The study cohort will be composed of women undergoing vaginal delivery and diagnosed with external anal sphincter injury after a vaginal delivery. |
Genetic: screening for single nucleotide polymorphism
samples will be tested for a set of single nucleotide polymorphism
Genetic: whole exome sequencing
samples will be tested for identifying specific genetic mutation
|
| Experimental: women without external anal sphincter injury The control group will be women who had a vaginal delivery without any clinically apparent perineal laceration |
Genetic: screening for single nucleotide polymorphism
samples will be tested for a set of single nucleotide polymorphism
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women with severe external anal sphincter injury during first vaginal delivery
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Healthy women undergoing vaginal delivery without any clinically apparent perineal laceration
Exclusion Criteria:
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Women with known metabolic or connective-tissue disorder (e.g., Ehlers-Danlos syndrome).
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Women with known neurologic disorder
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Women undergoing episiotomy cut or assisted delivery (e.g., vacuum or forceps delivery)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Haemek Medical Center | Afula | Israel |
Sponsors and Collaborators
- HaEmek Medical Center, Israel
Investigators
- Principal Investigator: Eyal Rom, MD, haemek medical center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0091-18-EMC