Clinical trial

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

Name
0091-18-EMC
Description
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.
Trial arms
Trial start
2020-09-04
Estimated PCD
2023-10-05
Trial end
2023-10-05
Status
Completed
Treatment
screening for single nucleotide polymorphism
samples from both arms will be tested for a set of single nucleotide polymorphism
Arms:
women with external anal sphincter injury, women without external anal sphincter injury
whole exome sequencing
samples from arm #1 (women with external anal sphincter) will be tested for identifying specific genetic mutation
Arms:
women with external anal sphincter injury
Size
93
Primary endpoint
difference in the frequency of of Single-nucleotide polymorphisms
through study completion, an average of 2 years
Eligibility 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two arms -\n\n1. with external anal sphincter injury\n2. 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', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 93, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

2 products

2 indications

Indication
Childbirth
Indication
Obstetric