Placenta PraeviaNCT02430038
Transperineal Ultrasound to Assess the Progress of Labour
An observational study of Placenta Praevia and Vaginismus, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Praevia, Vaginismus
- How many people
- 584 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to 19 Jan 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Group 1: acceptability and feasibility group Group 2: predictive model group
Who may be able to join
- Gestation 24-42 completed weeks at study entry
- Aged 18-44
- Cephalic
- Singleton pregnancies
- Nulliparous
- Multiparous (excluded for the term predictive model group)
- Multiple pregnancies (excluded for the term predictive model group)
- Established (Active) phase of labour (included for the term predictive model group) o Clinician opinion that patient is in the established phase of labour according to the current NICE guidelines
Who cannot join
- Younger than 18 years.
- Imminent iatrogenic intention to deliver
- Life threatening maternal or fetal compromise needing immediate medical attention and/or delivery
- Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study.
- Miscarriage
- Intra-uterine death
Show all 11Show fewer
- Previous cervical surgery eg. cone biopsy, cervical cerclage. Note- Single LLETZ is not excluded.
- Non-cephalic presentations
- Multiple pregnancies (for the term predictive model group)
- Multiparous patients (for the term predictive model group)
- Not in established labour (for the term predictive model group)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: The Sono-VE Study: Assessing the Acceptability and Feasibility of Transperineal Ultrasound and Developing an Ultrasound Based Predictive Model for Labour Outcome.
This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.
Read the detailed description
This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.
AIMS:
This study aims to firstly assess the effectiveness and acceptability of transperineal ultrasound in women presenting between 24 and 42 weeks gestation in comparison with digital vaginal examination (VE). Secondly, in all term (37-42 weeks) labouring women, investigators aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a predictive model for the outcome of labour.
- Conditions
- Placenta Praevia, Vaginismus
- Keywords
- transperineal ultrasound, labour, sonopartogram, prediction model
- Medical subject headings
- Placenta Previa, Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acceptability | To assess acceptability of intervention. Some patients from this group also participated in the other groups. | |
| Feasibility | Is it possible for ultrasound to measure labour parameters, where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls. Some patients from this group also participated in the other groups. | |
| Predictive Model | Nulliparous term labouring women with cephalic presentation. Some patients from this group also participated in the other groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean Delivery
Number of Caesarean deliveries in the prediction group
Measured: 24 months
Acceptability of Intrapartum Ultrasound
Acceptability of transabdominal and transperineal ultrasound to pregnant and labouring women. Use of modified W-DEQ questionnaires pre and post assessment. We recorded the number of women who completed both questionnaires.
Measured: 24 months
Feasibility of Ultrasound Labour Parameters
The outcome was the number of women who had all labour parameters measured by ultrasound.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Placenta PraeviaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, KU Leuven, Norwegian University of Science and Technology, British Medical Association
- Responsible party
- Sponsor
- Investigators
- Christoph Lees, MD MRCOG, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430038
- Sponsor's protocol ID
- 14HH2428
- Status last verified
- Sep 2024
- First submitted
- 24 Apr 2015
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sono-VE Study: Assessing the Acceptability and Feasibility of Transperineal Ultrasound and Developing an Ultrasound Based Predictive Model for Labour Outcome.
- ClinicalTrials.gov ID
- NCT02430038
- Acronym / sponsor ID
- 14HH2428
- Conditions
- Placenta Praevia, Vaginismus
- Keywords
- transperineal ultrasound, labour, sonopartogram, prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, KU Leuven, Norwegian University of Science and Technology, British Medical Association
- Study start
- Apr 2015
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.
Detailed description
This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.
AIMS:
This study aims to firstly assess the effectiveness and acceptability of transperineal ultrasound in women presenting between 24 and 42 weeks gestation in comparison with digital vaginal examination (VE). Secondly, in all term (37-42 weeks) labouring women, investigators aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a predictive model for the outcome of labour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptability | – | –To assess acceptability of intervention. Some patients from this group also participated in the other groups. |
| Feasibility | – | –Is it possible for ultrasound to measure labour parameters, where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls. Some patients from this group also participated in the other groups. |
| Predictive Model | – | –Nulliparous term labouring women with cephalic presentation. Some patients from this group also participated in the other groups. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1: acceptability and feasibility group Group 2: predictive model group
Key inclusion criteria (8 listed)
- Gestation 24-42 completed weeks at study entry
- Aged 18-44
- Cephalic
- Singleton pregnancies
- Nulliparous
Key exclusion criteria (11 listed)
- Younger than 18 years.
- Imminent iatrogenic intention to deliver
- Life threatening maternal or fetal compromise needing immediate medical attention and/or delivery
- Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study.
- Miscarriage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caesarean Delivery
Time frame: 24 months
Number of Caesarean deliveries in the prediction group
Acceptability of Intrapartum Ultrasound
Time frame: 24 months
Acceptability of transabdominal and transperineal ultrasound to pregnant and labouring women. Use of modified W-DEQ questionnaires pre and post assessment. We recorded the number of women who completed both questionnaires.
Feasibility of Ultrasound Labour Parameters
Time frame: 24 months
The outcome was the number of women who had all labour parameters measured by ultrasound.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christoph Lees, MD MRCOG principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Praevia and Vaginismus, run by Imperial College London 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 8 inclusion and 11 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 8 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Caesarean Delivery (time frame: 24 months). The study lists 3 primary outcomes in all. 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 8 Oct 2024.