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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Diagnostic test: 3D and 4D Transperineal Ultrasound

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: AHMED SAMY, MD; Phone Number: +201100681167; Email: ahmedsamy8233@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

primiparous group; women who will give birth to their first baby

Diagnostic test: 3D and 4D Transperineal Ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	gestational week 24 and 37

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2019
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): October 15, 2024

Study Registration Dates

• First Submitted: May 11, 2019
• First Submitted That Met QC Criteria: May 11, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 11, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: pelvic floor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No