The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury

Delivery, Obstetric Clinical Trial

Official title:

The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047433
• Other study ID #: 0091-18-EMC
• Status: Completed
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: October 5, 2023

Study information

• Verified date: February 2024
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delivery, Obstetric

Intervention

Genetic:
• screening for single nucleotide polymorphism
samples from both arms will be tested for a set of single nucleotide polymorphism
• whole exome sequencing
samples from arm #1 (women with external anal sphincter) will be tested for identifying specific genetic mutation

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in the frequency of of Single-nucleotide polymorphisms	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.	through study completion, an average of 2 years
Secondary	genetic mutation	specific genetic mutation among women with external anal sphincter injury that occurs during vaginal delivery	through study completion, an average of 2 years