CompletedNot Applicable

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

Israel93 participantsStarted 2020-09-04

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
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5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

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What they're measuring

difference in the frequency of of Single-nucleotide polymorphisms

Timeframe: through study completion, an average of 2 years

Trial details

NCT IDNCT04047433

SponsorHaEmek Medical Center, Israel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-05

View on ClinicalTrials.gov More Delivery, Obstetric trials