Pelvic Floor DisordersULTRASOUNDNCT04980235
Evaluation of Levator Ani Muscle Injury in Primiparous
An observational study of Pelvic Floor Disorders, run by Alexandria University at 1 site in Egypt.
Trial summary
pelvic floor muscles play an important role in supporting the pelvic organs. Vaginal birth leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and fecal incontinence can occur . Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- transperineal 3D ultrasound
- How many people
- 355 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 15 Aug 2021
- 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study was performed at Shatby maternity university hospital in Alexandria where 12000 deliveries per year are achieved . Over a 4-months period (February-June 2021. 355 eligible Egyptian women
Who may be able to join
- Primipara who had singleton fetus with cephalic presentation were recruited during their first post-partum visit ,1week post-delivery.
Who cannot join
- Multi para, Multifetal pregnancy, congenital anomalies of the genital tract past history of pelvic floor surgery or trauma or inability to come for follow up after 6weeks
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Shatby Maternity University Hospital
Alexandria, El-Khartoum Square, 21131
About this study
Official title: Evaluation of Levator Ani Muscle Injury in Primiparous Women at One and Six Weeks Postpartum Using 4D Transperineal Ultrasound: Comparative Cohort Study
pelvic floor muscles play an important role in supporting the pelvic organs. Vaginal birth leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and fecal incontinence can occur . Transperineal ultrasonography study pelvic floor pathology with minimal discomfort to the patient and lower cost than magnetic resonance imaging.
Read the detailed description
355 eligible Egyptian women had been enrolled Maternal Medical, surgical and obstetrical history was obtained. Demographic data (maternal age, maternal body mass index, duration of second stage labor, episiotomy, maternal injuries, neonatal birth weight, and neonatal head circumference were obtained. A modified questionnaire on symptoms of pelvic floor dysfunction was filled by the patients in both visits. vaginal examination with the women to detect any pelvic organ prolapse (quantified according to POP-Q classification system.
All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GE Voluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3D/4D ultrasound transducer. After emptying the bladder, ultrasound was done while the patient in the supine position. The probe was covered with clean glove adjusted and wrapped with an adhesive tape to make it firmly contacted to the probe and then placed on the perineum in the sagittal plane. The field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. Two 3D volumes (one with the patient at rest and one during Valsalva maneuver) were recorded.
- Conditions
- Pelvic Floor Disorders
- Being tested
- transperineal 3D ultrasound
- Keywords
- levator hiatus
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transperineal 3D ultrasoundDiagnostic test
All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GEVoluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3Dultrasound transducer
What is being measured
The primary outcome is the main question the study is designed to answer.
1. maximum diameters of the levator hiatus , pubovisceral muscle thickness Levator avulsion .
Measurements were performed in the axial plane at the level of 'minimal hiatal dimensions'
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start20 Feb 2021
- Primary completion30 Jul 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervit Sersy, Alexandria University
- Investigators
- Mervat AM Elsersy, MD, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980235
- Sponsor's protocol ID
- 0305043
- Acronym
- ULTRASOUND
- Status last verified
- Sep 2021
- First submitted
- 18 Jul 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie result
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Levator Ani Muscle Injury in Primiparous Women at One and Six Weeks Postpartum Using 4D Transperineal Ultrasound: Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT04980235
- Acronym / sponsor ID
- ULTRASOUND / 0305043
- Conditions
- Pelvic Floor Disorders
- Keywords
- levator hiatus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 28 Jul 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.
pelvic floor muscles play an important role in supporting the pelvic organs. Vaginal birth leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and fecal incontinence can occur . Transperineal ultrasonography study pelvic floor pathology with minimal discomfort to the patient and lower cost than magnetic resonance imaging.
Detailed description
355 eligible Egyptian women had been enrolled Maternal Medical, surgical and obstetrical history was obtained. Demographic data (maternal age, maternal body mass index, duration of second stage labor, episiotomy, maternal injuries, neonatal birth weight, and neonatal head circumference were obtained. A modified questionnaire on symptoms of pelvic floor dysfunction was filled by the patients in both visits. vaginal examination with the women to detect any pelvic organ prolapse (quantified according to POP-Q classification system.
All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GE Voluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3D/4D ultrasound transducer. After emptying the bladder, ultrasound was done while the patient in the supine position. The probe was covered with clean glove adjusted and wrapped with an adhesive tape to make it firmly contacted to the probe and then placed on the perineum in the sagittal plane. The field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. Two 3D volumes (one with the patient at rest and one during Valsalva maneuver) were recorded.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study was performed at Shatby maternity university hospital in Alexandria where 12000 deliveries per year are achieved . Over a 4-months period (February-June 2021. 355 eligible Egyptian women
Key inclusion criteria (1 listed)
- Primipara who had singleton fetus with cephalic presentation were recruited during their first post-partum visit ,1week post-delivery.
Key exclusion criteria (1 listed)
- Multi para, Multifetal pregnancy, congenital anomalies of the genital tract past history of pelvic floor surgery or trauma or inability to come for follow up after 6weeks
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 |
|---|---|---|
| transperineal 3D ultrasoundAll ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GEVoluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3Dultrasound transducer | Diagnostic test | – |
Primary outcome
1. maximum diameters of the levator hiatus , pubovisceral muscle thickness Levator avulsion .
Time frame: 6weeks
Measurements were performed in the axial plane at the level of 'minimal hiatal dimensions'
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 23 Sep 2021.
- Individual participant dataSharing planned: Yes. all individual participant data that underlie result
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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.
Mervat AM Elsersy, MD principal investigator
Assistant professor
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 Pelvic Floor Disorders, run by Alexandria 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 1 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 23 Sep 2021. 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?
1. maximum diameters of the levator hiatus , pubovisceral muscle thickness Levator avulsion . (time frame: 6weeks). 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 23 Sep 2021.