Delivery, ObstetricNCT04047433
The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
A study testing screening for single nucleotide polymorphism and whole exome sequencing in people with Delivery, Obstetric, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery, Obstetric
- What is being tested?
- screening for single nucleotide polymorphism and whole exome sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Sep 2020to 5 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with severe external anal sphincter injury during first vaginal delivery
- Healthy women undergoing vaginal delivery without any clinically apparent perineal laceration
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Delivery, Obstetric
- Being tested
- screening for single nucleotide polymorphism, whole exome sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening for single nucleotide polymorphismGenetic
samples from both arms will be tested for a set of single nucleotide polymorphism
whole exome sequencingGenetic
samples from arm #1 (women with external anal sphincter) will be tested for identifying specific genetic mutation
| Study group | Role | What they receive |
|---|---|---|
| women with external anal sphincter injury | Experimental | The study cohort will be composed of women undergoing vaginal delivery and diagnosed with external anal sphincter injury after a vaginal delivery. Receives: Genetic: screening for single nucleotide polymorphism; Genetic: whole exome sequencing |
| women without external anal sphincter injury | Experimental | The control group will be women who had a vaginal delivery without any clinically apparent perineal laceration Receives: Genetic: screening for single nucleotide polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
genetic mutation
specific genetic mutation among women with external anal sphincter injury that occurs during vaginal delivery
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start4 Sep 2020
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery, ObstetricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyal Rom, MD, HaEmek Medical Center, Israel
- Investigators
- Hedi Raischer, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047433
- Sponsor's protocol ID
- 0091-18-EMC
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2019
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
- ClinicalTrials.gov ID
- NCT04047433
- Acronym / sponsor ID
- 0091-18-EMC
- Conditions
- Delivery, Obstetric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| women with external anal sphincter injury | Experimental | Genetic: screening for single nucleotide polymorphism, Genetic: whole exome sequencingThe study cohort will be composed of women undergoing vaginal delivery and diagnosed with external anal sphincter injury after a vaginal delivery. |
| women without external anal sphincter injury | Experimental | Genetic: screening for single nucleotide polymorphismThe control group will be women who had a vaginal delivery without any clinically apparent perineal laceration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with severe external anal sphincter injury during first vaginal delivery
- Healthy women undergoing vaginal delivery without any clinically apparent perineal laceration
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening for single nucleotide polymorphismsamples from both arms will be tested for a set of single nucleotide polymorphism | Genetic | women with external anal sphincter injury, women without external anal sphincter injury |
| whole exome sequencingsamples from arm #1 (women with external anal sphincter) will be tested for identifying specific genetic mutation | Genetic | women with external anal sphincter injury |
Primary outcome
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.
1 secondary outcome
genetic mutation
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hedi Raischer, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening for single nucleotide polymorphism and whole exome sequencing in people with Delivery, Obstetric, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the frequency of of Single-nucleotide polymorphisms (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.