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

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ClinicalTrials.gov Identifier: NCT04047433
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Eyal Rom, MD, HaEmek Medical Center, Israel

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
Delivery, Obstetric Genetic: screening for single nucleotide polymorphism Genetic: whole exome sequencing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047433


Contacts
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Contact: eyal rom, MD 972546747434 eyalro@clalit.org.il

Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Eyal Rom, MD haemek medical center

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Responsible Party: Eyal Rom, MD, Principal Investigator, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT04047433     History of Changes
Other Study ID Numbers: 0091-18-EMC
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No