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

March 12, 2015 updated by: Bezmialem Vakif University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

72

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levator Avulsion
Time Frame: 01.07.2014
01.07.2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (ESTIMATE)

March 18, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVU1/13-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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