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Completed

NCT Number: NCT04047433

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

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.

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Key information

Conditions

Delivery, Obstetric

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haemek Medical Center

Afula, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

screening for single nucleotide polymorphism

Genetic

samples from both arms will be tested for a set of single nucleotide polymorphism

Whole Exome Sequencing

Genetic

samples from arm #1 (women with external anal sphincter) will be tested for identifying specific genetic mutation

Primary outcomes

  1. difference in the frequency of of Single-nucleotide polymorphisms

    Time frame: 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 outcomes

  1. genetic mutation

    Time frame: through study completion, an average of 2 years

    specific genetic mutation among women with external anal sphincter injury that occurs during vaginal delivery

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2019
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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