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OpenTrials
Completed

NCT Number: NCT02265081

A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome

The proposed study is to evaluate if there are specific factors in the pelvic floor functional anatomy which can predict the ability of having a vaginal birth after caesarean section.

Physical characteristics of the soft tissue in the female pelvis play an important role in successful vaginal delivery. A "tight" or less distensible pelvic floor muscles may influence mode of delivery, leading to poor labour progression and by compressing foetal head produce CTG abnormality such as decelerations, both resulting in caesarean delivery.

One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the passage of fetal head through the birth canal by stretching and distending. Therefore distensibility of the female pelvic floor influences mode of delivery.

Three hundred patients, in the third trimester of pregnancy, will be recruited via the antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible participants are pregnant women who had either one or no vaginal births, or one caesarean section and who can give an informed consent and maintain their autonomy regarding mode of delivery with understanding of the forthcoming study results. Participants will be excluded if they sustain any obstetric complications that may impede on time and mode of delivery including an emergency prelabour caesarean section.

Ultrasonographic assessment of the differences in the pelvic characteristics of these women will be used to predict a successful of trial of vaginal delivery after caesarean section (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is a simple (single ultrasound assessment) that can be used to help inform women's choice regarding mode of delivery.

Results from this research could be a pioneering blueprint for further studies, as there is very little known about this topic.

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Key information

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Women's Hospital

Birmingham, B29 6SN, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking women
  • over 16 years old women
  • women willing to provide written informed consent
  • women who had either prior vaginal delivery or caesarean section or no prior birth experience

Exclusion criteria

  • Women who cannot give an informed consent,
  • under the age of consent,
  • any participants whose pregnancies complicated during the antenatal period that may influence decision on time and mode of delivery that is anyone who has to undergo an emergency prelabour LSCS,
  • nonEnglish speaking women
  • less than 16 years old women

Treatment and study plan

Ultrasound

Procedure

pelvic floor ultrasound

uroflow-meter

Procedure

uroflow meter: measurement of passed urine volume

Primary outcomes

  1. vaginal delivery

    Time frame: 12 months

Secondary outcomes

  1. voiding problems

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Birmingham Women's NHS Foundation Trust

Other Gov

Registry information

Official study title

A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome.

Acronym: PLUSSMODEL

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2014
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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