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

Pregnancy Clinical Trial

— PLUSSMODEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265081
• Other study ID #: U1111-1162-7720
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: July 26, 2015
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Birmingham Women's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Westminster Ethical Committee, London
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

1. English speaking women

2. over 16 years old women

3. women willing to provide written informed consent

4. women who had either prior vaginal delivery or caesarean section or no prior birth experience

Exclusion Criteria:

1. Women who cannot give an informed consent,

2. under the age of consent,

3. 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,

4. nonEnglish speaking women

5. less than 16 years old women

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Pregnancy

Intervention

Procedure:
• ultrasound
pelvic floor ultrasound
• uroflow-meter
uroflow meter: measurement of passed urine volume

Locations

Country	Name	City	State
United Kingdom	Birmingham Women's Hospital	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Birmingham Women's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaginal delivery		12 months	No
Secondary	voiding problems		12 months	No