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Levator Hiatal Dimensions and Mode of Delivery

NCT05849584 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-06-24

No results posted yet for this study

Summary

The aim of this observational study is to learn about how muscle dimensions of the pelvic floor measured during pregnancy in primigravida impact birth mecanics and mode of delivery. Tha main aims are to 1. Explore associations between mode of delivery and hiatal dimensions measured by transperineal ultrasound antenatally and 2. Explore the association between duration of 2nd stage of labour and hiatal dimensions.

A pelvic floor ultrasound examination will be performed between pregnancy week 12 and 20 and levator ani muscle hiatal dimensions will be compared between women having a normal vaginal delivery and women with emergency cesarean or operative vaginal deliveries.

Conditions

  • Pelvic Floor; Rupture
  • Childbirth Problems
  • Pelvic Floor Dyssynergia

Interventions

OTHER

Transperineal ultrasound

A 2D scan will be performed of one experienced clinician. The average of 3 2D levator hiatal anteroposterior measurements will be stored. Then, a 3D/4D ultrasound examination of the pelvic floor will be performed using a Voluson S10, E8 or E10 (GE healthcare, Zipf, Austria) device with a RAB 4-8 MHz curved array transducer with the acquisition angle set at 85 degrees. Offline analysis of the ultrasound volumes will be performed using the 4D view (GE Healthcare, Austria) software, blinded to all clinical data. Hiatal anteroposterior diameter will be measured in both 2D and 3D. Hiatal area and hiatal transverse diameter will be measured in the 3D volume

Sponsors & Collaborators

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Ingrid Volløyhaug, PhD · St. Olavs Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849584 on ClinicalTrials.gov