A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome (PLUSSMODEL)
Primary Purpose
Pelvic Floor Disorders, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ultrasound
uroflow-meter
Sponsored by
About this trial
This is an interventional supportive care trial for Pelvic Floor Disorders
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
Sites / Locations
- Birmingham Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
nulliparous women
parous women
parous women - VBAC
Arm Description
internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
Outcomes
Primary Outcome Measures
vaginal delivery
Secondary Outcome Measures
voiding problems
Full Information
NCT ID
NCT02265081
First Posted
October 9, 2014
Last Updated
July 26, 2015
Sponsor
Birmingham Women's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02265081
Brief Title
A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome
Acronym
PLUSSMODEL
Official Title
A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Birmingham Women's NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Pregnancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nulliparous women
Arm Type
Active Comparator
Arm Description
internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
Arm Title
parous women
Arm Type
Experimental
Arm Description
those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
Arm Title
parous women - VBAC
Arm Type
Experimental
Arm Description
those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
Intervention Type
Procedure
Intervention Name(s)
ultrasound
Intervention Description
pelvic floor ultrasound
Intervention Type
Procedure
Intervention Name(s)
uroflow-meter
Intervention Description
uroflow meter: measurement of passed urine volume
Primary Outcome Measure Information:
Title
vaginal delivery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
voiding problems
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Hard
Organizational Affiliation
R&D Dept, Birmingham Women's Hospital, UK
Official's Role
Study Chair
Facility Information:
Facility Name
Birmingham Women's Hospital
City
Birmingham
ZIP/Postal Code
B29 6SN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome
We'll reach out to this number within 24 hrs