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

NCT03950479 | Unknown

• 1 other identifier: pelvic floor
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• 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

  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

  24 weeks and 37 weeks of gestation

• Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D transperineal Ultrasound

  gestational week 24 and 37

Study Arms (1)

primiparous group

women who will give birth to their first baby

Diagnostic Test: 3D and 4D Transperineal Ultrasound

Interventions

3D and 4D Transperineal Ultrasound DIAGNOSTIC_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.

primiparous group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Wuerzburg University Hospital: collaborator

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED SAMY, MD

CONTACT

+201100681167; ahmedsamy8233@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of obstetrics and gynecology

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 15, 2019
• Study Start: June 15, 2019
• Primary Completion: June 1, 2024
• Study Completion: October 15, 2024
• Last Updated: May 15, 2019

Record last verified: 2019-05