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

Pelvic Floor Disorders Clinical Trial

— OTELaPFC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391753
• Other study ID #: BVU1/13-1
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: March 12, 2015
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Observational

Clinical Trial 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

Description:

Sixty four of 72 primiparous women who vaginally delivered singleton babies that eligible for trial were examined within 36 h of delivery and at 3rd months after delivery.Parameters such as age, episiotomy, mode of delivery, duration of labor, birthweight and antenatal biparietal diameter (BPD) measures were obtained from the clinical files. The length of the first stage of labor was calculated from the beginning of regular and at least three strong uterine contractions in 30 min according to the women's statements, tocography and palpations to full dilatation. All static ultrasound volume acquisitions were performed by the same experienced sonographer trained in pelvic floor ultrasound within 36 h of delivery. Same patients invited for second evaluation.Two 3-D volumes (one at rest, one on Valsalva maneuver) were recorded in the supine position after voiding.The effectiveness of valsalva was ascertained by observing 2-D ultrasounds before acquiring volumes.. LAM thickness is determined at the plane of minimal hiatal dimensions rather than 1-1.5 cm above the actual LAM hiatus where LAM thickness is maximal as described by Dietz et al.(15). The following parameters were assessed for this study: maximum diameters of the LAM hiatus (anteroposterior and transverse) at rest and on Valsalva maneuver; area of the LAM hiatus at rest and on Valsalva; and pubovisceral muscle thickness (left and right of the rectum), difference in anteroposterior and transverse diameter of hiatus and LAM hiatus area between rest and Valsalva

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Device:
• Transperineal 3D Ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levator Avulsion		01.07.2014	No