Anal Sphincter Tear Complicating DeliveryNCT05046704
Peripartum Ultrasound in the Prediction and Diagnosis of OASIs
An observational study of Anal Sphincter Tear Complicating Delivery, run by Cairo University at 1 site in Egypt.
Trial summary
To determine the value of peripartum scan measurement(s) in the prediction and diagnosis of Obstetric Anal Sphincter Injuries (OASIs) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Sphincter Tear Complicating Delivery
- What is being tested?
- peripartum transperineal Ultrasound
- Type of treatment
- Medical device
- How many people
- 1,250 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2021to 30 May 2023
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: Nulliparous, pregnant women in Term, Vertex, Singleton, 18 years or over, in labour.
Who may be able to join
- Nulliparous .
- Term, Vertex, Singleton living pregnancy.
- Maternal age 18 years or over.
- In labour.
Who cannot join
- Exclusion criteria are those who do not fit in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Peripartum Ultrasound in the Prediction and Diagnosis of Obstetric Anal Sphincter Injuries
To determine the value of peripartum scan measurement(s) in the prediction and diagnosis of Obstetric Anal Sphincter Injuries (OASIs)
Read the detailed description
1.1.Obstetric Anal Sphincter Injuries (OASIs) Obstetric anal sphincter injuries (OASIs) are serious complications of vaginal birth with a reported incidence throughout Europe and globally, from 1-10% with recent UK data demonstrating a steadily rising incidence of this type of trauma over the past 12 years .
OASIs is one of the most significant risk factors for anal incontinence in young women as well as other complications of long-term dyspareunia and perineal pain.Despite optimal primary repair, approximately 39% of women who sustain an OASIs will suffer from anal incontinence. Several studies have reported a much higher risk of anal incontinence with subsequent deliveries and the potential for symptoms to progress with time.
1.2. Prediction of OASIs With the wealth of population based databases that are now available prediction models are being developed to assist in clinical decision making. Several large population based cohort studies have identified various independent risk factors for sustaining primary or recurrent OASIS. These include nulliparity, increased birth weight, operative vaginal delivery, persistent occipito-posterior position, prolonged pushing phase, induction of labour, use of epidural analgesia and shoulder dystocia, although findings across studies are contradictory.However there is paucity of information relating to the impact of risk factors that can only be known prior to the actual birth both on the likelihood of OASIs occurring de-novo and the usefulness of such information for counselling women at potential risk of sustaining a primary OASIs.
Although members of the investigators group have previously demonstrated that some of these prediction models have been suggested to have good discriminatory value, they do not necessarily confer a good clinical value. Although the model was useful in ruling out risk of OASIs in women with no risk factors, it was not as good in ruling-in an OASIS - that means that a women presenting with all of the known clinical risk factors cannot be differentiated at any higher risk than a women with a smaller subset of these risk factors. Hence limiting its clinical usability.
1.3. Ultrasound and OASIs management Transperineal and endoanal ultrasound scanning is currently used for the diagnosis and management of OASIs. Indeed, they form part of the recommended practice for determining the best mode of birth in pregnancies following OASIs.
Studies have also assessed some transperineal sonographic parameters, like the ano-vaginal distance (AVD), as a way of alerting clinicians to the possibility of OASIs. This measure has been used postnatally and a it was concluded that a short AVD could be a warning sign of possible external sphincter injury before suturing. The authors of this study suggested that an AVD of 20 mm seemed to indicate a cutoff level of the occurrence of external sphincter injury. Nevertheless, The authors of this study stressed on the need of further evaluation of their findings.
A However, to the investigators knowledge such parameter has not been assessed as an intrapartum tool, in combination with other radiological or clinical parameters, in the prediction of the risk of OASIs.
- Being tested
- peripartum transperineal Ultrasound
- Keywords
- Obstetric Anal Sphincter Injuries, peripartum transperineal US, ano-vaginal distance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripartum transperineal UltrasoundDevice
The anovaginal distance (AVD) will be measured by transperineal ultrasound ,The distance between the anal edge of the internal sphincter and the probe will then be measured in millimeters The ultrasound assessment of the anal sphincters at rest and during contraction will be performed postnatally using a dynamic 2-dimensional transperineal ultrasound with the patient in a supine position, an empty bladder.
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Anal Sphincter Injuries(OASIs) as diagnosed on clinical examination
Detection the accuracy of peripartum transperineal US in prediction and diagnosis of obstetric anal sphincter injuries by measuring the ano vaginal distance in mm using vaginal probe of US and measuring the sub-pubic angle ueing 3D/4D probe of US intrapartum and using rolling technique postnatally for detection of occurrence of OASIs.
Measured: baseline
Secondary outcomes (2)
1- Other degrees of perineal trauma
to detect first and second degrees of perineal trauma by inspection and palpation to the perineal injuries.
Measured: baseline
2-Duration of second stage
detection the time from fully dilated cervix to complete delivery of the fetus measured in seconds.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Oct 2021
- Primary completion14 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Sphincter Tear Complicating DeliveryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niven Abu Al-Foutouh Adly Shaban, Cairo University
- Investigators
- Sherif M Negm, Prof.Dr, Study chair, Kasr Alainy Hospital-Cairo University.Dalia S ZoElfakar, Assistant Prof.Dr, Study chair, Kasr Alainy Hospital-Cairo University.Mohamed F Youssef, : Lecturer Dr, Study chair, Kasr Alainy Hospital-Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046704
- Sponsor's protocol ID
- peripartum US in OASIs.
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Peripartum Ultrasound in the Prediction and Diagnosis of Obstetric Anal Sphincter Injuries
- ClinicalTrials.gov ID
- NCT05046704
- Acronym / sponsor ID
- peripartum US in OASIs.
- Keywords
- Obstetric Anal Sphincter Injuries, peripartum transperineal US, ano-vaginal distance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 14 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 16 Sep 2021 (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.
To determine the value of peripartum scan measurement(s) in the prediction and diagnosis of Obstetric Anal Sphincter Injuries (OASIs)
Detailed description
1.1.Obstetric Anal Sphincter Injuries (OASIs) Obstetric anal sphincter injuries (OASIs) are serious complications of vaginal birth with a reported incidence throughout Europe and globally, from 1-10% with recent UK data demonstrating a steadily rising incidence of this type of trauma over the past 12 years .
OASIs is one of the most significant risk factors for anal incontinence in young women as well as other complications of long-term dyspareunia and perineal pain.Despite optimal primary repair, approximately 39% of women who sustain an OASIs will suffer from anal incontinence. Several studies have reported a much higher risk of anal incontinence with subsequent deliveries and the potential for symptoms to progress with time.
1.2. Prediction of OASIs With the wealth of population based databases that are now available prediction models are being developed to assist in clinical decision making. Several large population based cohort studies have identified various independent risk factors for sustaining primary or recurrent OASIS. These include nulliparity, increased birth weight, operative vaginal delivery, persistent occipito-posterior position, prolonged pushing phase, induction of labour, use of epidural analgesia and shoulder dystocia, although findings across studies are contradictory.However there is paucity of information relating to the impact of risk factors that can only be known prior to the actual birth both on the likelihood of OASIs occurring de-novo and the usefulness of such information for counselling women at potential risk of sustaining a primary OASIs.
Although members of the investigators group have previously demonstrated that some of these prediction models have been suggested to have good discriminatory value, they do not necessarily confer a good clinical value. Although the model was useful in ruling out risk of OASIs in women with no risk factors, it was not as good in ruling-in an OASIS - that means that a women presenting with all of the known clinical risk factors cannot be differentiated at any higher risk than a women with a smaller subset of these risk factors. Hence limiting its clinical usability.
1.3. Ultrasound and OASIs management Transperineal and endoanal ultrasound scanning is currently used for the diagnosis and management of OASIs. Indeed, they form part of the recommended practice for determining the best mode of birth in pregnancies following OASIs.
Studies have also assessed some transperineal sonographic parameters, like the ano-vaginal distance (AVD), as a way of alerting clinicians to the possibility of OASIs. This measure has been used postnatally and a it was concluded that a short AVD could be a warning sign of possible external sphincter injury before suturing. The authors of this study suggested that an AVD of 20 mm seemed to indicate a cutoff level of the occurrence of external sphincter injury. Nevertheless, The authors of this study stressed on the need of further evaluation of their findings.
A However, to the investigators knowledge such parameter has not been assessed as an intrapartum tool, in combination with other radiological or clinical parameters, in the prediction of the risk of OASIs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Nulliparous, pregnant women in Term, Vertex, Singleton, 18 years or over, in labour.
Key inclusion criteria (4 listed)
- Nulliparous .
- Term, Vertex, Singleton living pregnancy.
- Maternal age 18 years or over.
- In labour.
Key exclusion criteria (1 listed)
- Exclusion criteria are those who do not fit in the inclusion criteria.
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 |
|---|---|---|
| peripartum transperineal UltrasoundThe anovaginal distance (AVD) will be measured by transperineal ultrasound ,The distance between the anal edge of the internal sphincter and the probe will then be measured in millimeters The ultrasound assessment of the anal sphincters at rest and during contraction will be performed postnatally using a dynamic 2-dimensional transperineal ultrasound with the patient in a supine position, an empty bladder. | Device | – |
Primary outcome
Obstetric Anal Sphincter Injuries(OASIs) as diagnosed on clinical examination
Time frame: baseline
Detection the accuracy of peripartum transperineal US in prediction and diagnosis of obstetric anal sphincter injuries by measuring the ano vaginal distance in mm using vaginal probe of US and measuring the sub-pubic angle ueing 3D/4D probe of US intrapartum and using rolling technique postnatally for detection of occurrence of OASIs.
2 secondary outcomes
1- Other degrees of perineal trauma
Time frame: baseline
2-Duration of second stage
Time frame: baseline
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 30 Aug 2023.
- Baghestan, E., Irgens, L.M., Børdahl, P.E., Rasmussen, S., (2010): Trends in Risk Factors for Obstetric Anal Sphincter Injuries in Norway. Obstet. Gynecol. 116, 25-34.Link provided by the sponsor.
- -Bellussi, F., Ghi, T., Youssef, A., Salsi, G., Giorgetta, F., Parma, D., Simonazzi, G., Pilu, G.,( 2017): The use of intrapartum ultrasound to diagnose malpositions and cephalic malpresentations. Am. J. Obstet. Gynecol. 217, 633-641.Link provided by the sponsor.
- de Leeuw, J.., Struijk, P.., Vierhout, M.., Wallenburg, H.C.., (2001): Risk factors for third degree perineal ruptures during delivery. Br. J. Obstet. Gynaecol. 108, 383-387. https://doi.org/10.1016/S0306-5456(00)00090-5Link provided by the sponsor.
- -Ismail, K.M.K.,( 2017): Perineal trauma at childbirth, Perineal Trauma at Childbirth.Link provided by the sponsor.
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.
Sherif M Negm, Prof.Dr study chair
Kasr Alainy Hospital-Cairo University.
Dalia S ZoElfakar, Assistant Prof.Dr study chair
Kasr Alainy Hospital-Cairo University.
Mohamed F Youssef, : Lecturer Dr study chair
Kasr Alainy Hospital-Cairo University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Sphincter Tear Complicating Delivery, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 1 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 30 Aug 2023. 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 Egypt. 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?
Obstetric Anal Sphincter Injuries(OASIs) as diagnosed on clinical examination (time frame: baseline). 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 30 Aug 2023.