ClinicalTrials.Veeva

Menu

Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Pelvic Floor Disorders

Treatments

Diagnostic Test: 3D and 4D Transperineal Ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT03950479
pelvic floor

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

primiparous group
Description:
women who will give birth to their first baby
Treatment:
Diagnostic Test: 3D and 4D Transperineal Ultrasound

Trial contacts and locations

0

Loading...

Central trial contact

AHMED SAMY, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems