Clinical Trials Directory

Trials / Completed

CompletedNCT02391753

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
72 (actual)
Sponsor
Bezmialem Vakif University · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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

Detailed 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

Conditions

Interventions

TypeNameDescription
DEVICETransperineal 3D UltrasoundImaging 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.

Timeline

Start date
2014-07-01
Primary completion
2015-02-01
Completion
2015-02-01
First posted
2015-03-18
Last updated
2015-03-18

Source: ClinicalTrials.gov record NCT02391753. Inclusion in this directory is not an endorsement.

Evaluation of Labor Related Pelvic Floor Changes: A 3D Transperineal Ultrasound Study (NCT02391753) · Clinical Trials Directory