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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Egypt1 site
  • Niven

    Cairo

Other trials in Egypt

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.

  1. 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. 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. 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.

  1. First posted16 Sep 2021
  2. Study start30 Oct 2021
  3. Primary completion14 May 2023
  4. Study completion30 May 2023

Resources

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)
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

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.

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