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Clinical Trials/NCT02265081
NCT02265081
Completed
Not Applicable

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

Birmingham Women's NHS Foundation Trust1 site in 1 country135 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor Disorders
Sponsor
Birmingham Women's NHS Foundation Trust
Enrollment
135
Locations
1
Primary Endpoint
vaginal delivery
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aneta Obloza

DR ANETA OBLOZA

Birmingham Women's NHS Foundation Trust

Eligibility Criteria

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

Outcomes

Primary Outcomes

vaginal delivery

Time Frame: 12 months

Secondary Outcomes

  • voiding problems(12 months)

Study Sites (1)

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