Pelvic Floor DisordersNCT03950479
Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound
An observational study of Pelvic Floor Disorders, run by Cairo University.
Trial summary
Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- 3D and 4D Transperineal Ultrasound
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2019to 15 Oct 2024
- 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 to 45 years
- Women only
- Adult
Study population: Women giving birth to their first child at Cairo University Hospital, Egypt and University Hospital Würzburg, Germany.
Who may be able to join
- Women giving birth to their first child at Cairo University Hospital, Egypt and University Hospital Würzburg, Germany.
Who cannot join
- Previous pregnancy of more than 16 weeks.
- preterm delivery less than 32 weeks gestation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound and Its Relation to Pregnancy and Labor
Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery.
Read the detailed description
At the Department of Obstetrics and Gynaecology, Cairo University Hospital there are approximately 29000 deliveries annually and 10000 women are giving birth for the first time.
Challenges: The invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. The biggest challenges in the project will be logistical. To be able to inform, recruit and follow women having their first child is a challenge in itself.
Applications: If it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic cesarean section to avoid disabling incontinence and prolapse later in life.
- Conditions
- Pelvic Floor Disorders
- Being tested
- 3D and 4D Transperineal Ultrasound
- 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.
3D and 4D Transperineal UltrasoundDiagnostic test
The evaluation of Pelvic Floor Muscles with 3D and 4D transperineal ultrasound using A Voluson E6 system (GE Healthcare, Zipf, Austria) with RAB 8-4-MHz volume transducer for all acquisitions. Measurements will be performed in axial planes. The levator hiatus area (LHA), the antero-posterior (AP) diameter and the left-right (LR) transverse diameter will be analyzed at rest, during pelvic floor contraction and on maximal Valsalva maneuver.
| Study group | Role | What they receive |
|---|---|---|
| primiparous group | women who will give birth to their first baby Receives: Diagnostic Test: 3D and 4D Transperineal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Levator Hiatus Area at Rest Measured Via 3-dimensional transperineal Ultrasound at Gestational Week 24 and 37
3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 24 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes
Measured: 24 weeks and 37 weeks of gestation
Secondary outcomes (2)
Change in Levator Hiatus Area at Contraction Measured Via 3D transperineal Ultrasound at Gestational Week 24 and 37
3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 24 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.
Measured: 24 weeks and 37 weeks of gestation
Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D transperineal Ultrasound
3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 24 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements altogether. The change in LH area was computed between the two different timepoints.
Measured: gestational week 24 and 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start15 Jun 2019 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
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 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuerzburg University Hospital
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950479
- Sponsor's protocol ID
- pelvic floor
- Status last verified
- May 2019
- First submitted
- 11 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound and Its Relation to Pregnancy and Labor
- ClinicalTrials.gov ID
- NCT03950479
- Acronym / sponsor ID
- pelvic floor
- Conditions
- Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Wuerzburg University Hospital
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 15 May 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.
Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery.
Detailed description
At the Department of Obstetrics and Gynaecology, Cairo University Hospital there are approximately 29000 deliveries annually and 10000 women are giving birth for the first time.
Challenges: The invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. The biggest challenges in the project will be logistical. To be able to inform, recruit and follow women having their first child is a challenge in itself.
Applications: If it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic cesarean section to avoid disabling incontinence and prolapse later in life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primiparous group | – | Diagnostic Test: 3D and 4D Transperineal Ultrasoundwomen who will give birth to their first baby |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women giving birth to their first child at Cairo University Hospital, Egypt and University Hospital Würzburg, Germany.
Key inclusion criteria (1 listed)
- Women giving birth to their first child at Cairo University Hospital, Egypt and University Hospital Würzburg, Germany.
Key exclusion criteria (2 listed)
- Previous pregnancy of more than 16 weeks.
- preterm delivery less than 32 weeks gestation.
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 |
|---|---|---|
| 3D and 4D Transperineal UltrasoundThe evaluation of Pelvic Floor Muscles with 3D and 4D transperineal ultrasound using A Voluson E6 system (GE Healthcare, Zipf, Austria) with RAB 8-4-MHz volume transducer for all acquisitions. Measurements will be performed in axial planes. The levator hiatus area (LHA), the antero-posterior (AP) diameter and the left-right (LR) transverse diameter will be analyzed at rest, during pelvic floor contraction and on maximal Valsalva maneuver. | Diagnostic test | primiparous group |
Primary outcome
Change in Levator Hiatus Area at Rest Measured Via 3-dimensional transperineal Ultrasound at Gestational Week 24 and 37
Time frame: 24 weeks and 37 weeks of gestation
3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 24 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes
2 secondary outcomes
Change in Levator Hiatus Area at Contraction Measured Via 3D transperineal Ultrasound at Gestational Week 24 and 37
Time frame: 24 weeks and 37 weeks of gestation
Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D transperineal Ultrasound
Time frame: gestational week 24 and 37
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
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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.
AHMED SAMY, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Cairo University.
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 2 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: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY, MD (+201100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Levator Hiatus Area at Rest Measured Via 3-dimensional transperineal Ultrasound at Gestational Week 24 and 37 (time frame: 24 weeks and 37 weeks of gestation). 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 15 May 2019.