Clinical trial NCT03950479: Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound
Official title: Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound and Its Relation to Pregnancy and Labor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Wuerzburg University Hospital
First posted: 2019-05-15
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women giving birth to their first child at Cairo University Hospital, Egypt and University Hospital Würzburg, Germany.

Brief 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%). 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.

Eligibility criteria: Inclusion Criteria:

* Women giving birth to their first child at Cairo University Hospital, Egypt and University Hospital Würzburg, Germany.

Exclusion Criteria:

* Previous pregnancy of more than 16 weeks.
* preterm delivery less than 32 weeks gestation.

Primary outcomes:
measure: Change in Levator Hiatus Area at Rest Measured Via 3-dimensional transperineal Ultrasound at Gestational Week 24 and 37
timeFrame: 24 weeks and 37 weeks of gestation
Secondary outcomes:
measure: Change in Levator Hiatus Area at Contraction Measured Via 3D transperineal Ultrasound at Gestational Week 24 and 37
timeFrame: 24 weeks and 37 weeks of gestation
measure: Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D transperineal Ultrasound
timeFrame: gestational week 24 and 37
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: