Evaluation of Labor Related Pelvic Floor Changes: A 3D Transperineal Ultrasound Study

NCT02391753 | Completed

• 1 other identifier: BVU1/13-1
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study was the define changes LAM morphology, biometric measurements of the LAM and genital hiatus at immediate evaluation of pelvic floor and at 3 month after delivery was evaluated. We also sought to define the optimal time for evaluation of pelvic floor after childbirth

Conditions

Pelvic Floor Disorders

Keywords

levator avulsion; transperineal ultrasound; levator hiatus

Outcome Measures

Primary Outcomes (1)

• Levator Avulsion

  01.07.2014

Interventions

Transperineal 3D Ultrasound DEVICE

Imaging was performed with women in lithotomy position with empty bladder. The probe was covered with a sterile film and placed on the perineum in the sagittal plane. The field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. Analysis of stored volumes was conducted offline by another experienced investigator blinded to clinical and delivery data.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

primiparous women who vaginally delivered singleton babies that eligible for trial were examined within 36 h of delivery

You may qualify if:

• primiparous women who vaginally delivered singleton babies that eligible for trial were examined within 36 h of delivery

You may not qualify if:

• operative deliveries (forceps or vacuum assisted), multifetal pregnancy, cesarean delivery, handicap in lithotomy position, refused consent and uncooperative patient for effective Valsalva maneuver.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03