Pelvic Floor DisordersPLUSSMODELNCT02265081
A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome
A study testing ultrasound and uroflow-meter in people with Pelvic Floor Disorders and Pregnancy, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Pregnancy
- What is being tested?
- ultrasound and uroflow-meter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Pelvic Floor Disorders, Pregnancy
- Being tested
- ultrasound, uroflow-meter
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundProcedure or surgery
pelvic floor ultrasound
uroflow-meterProcedure or surgery
uroflow meter: measurement of passed urine volume
| Study group | Role | What they receive |
|---|---|---|
| nulliparous women | Active comparator | internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester Receives: Procedure: ultrasound; Procedure: uroflow-meter |
| parous women | Experimental | those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester Receives: Procedure: ultrasound; Procedure: uroflow-meter |
| parous women - VBAC | Experimental | those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester Receives: Procedure: ultrasound; Procedure: uroflow-meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal delivery
Measured: 12 months
Secondary outcomes (1)
voiding problems
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aneta Obloza, Birmingham Women's NHS Foundation Trust
- Investigators
- Kelly Hard, Study chair, R&D Dept, Birmingham Women's Hospital, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265081
- Sponsor's protocol ID
- U1111-1162-7720
- Acronym
- PLUSSMODEL
- Status last verified
- Jul 2015
- First submitted
- 9 Oct 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome.
- ClinicalTrials.gov ID
- NCT02265081
- Acronym / sponsor ID
- PLUSSMODEL / U1111-1162-7720
- Conditions
- Pelvic Floor Disorders, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nulliparous women | Active comparator | Procedure: ultrasound, Procedure: uroflow-meterinternal ultrasound in the 3rd trimester uroflow meter in 3rd trimester |
| parous women | Experimental | Procedure: ultrasound, Procedure: uroflow-meterthose who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester |
| parous women - VBAC | Experimental | Procedure: ultrasound, Procedure: uroflow-meterthose with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundpelvic floor ultrasound | Procedure or surgery | nulliparous women, parous women, parous women - VBAC |
| uroflow-meteruroflow meter: measurement of passed urine volume | Procedure or surgery | nulliparous women, parous women, parous women - VBAC |
Primary outcome
vaginal delivery
Time frame: 12 months
1 secondary outcome
voiding problems
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Hard study chair
R&D Dept, Birmingham Women's Hospital, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and uroflow-meter in people with Pelvic Floor Disorders and Pregnancy, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal delivery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.