An observational study in Placenta Praevia and Vaginismus, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Imperial College London · Observational
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.
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.
80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.
This study's enrollment of 584 is above the median of 100 across 32 observational studies indexed under Placenta Previa.
Browse Placenta Previa studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Group 1: acceptability and feasibility group
Group 2: predictive model group
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To assess acceptability of intervention. Some patients from this group also participated in the other groups.
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.
Nulliparous term labouring women with cephalic presentation. Some patients from this group also participated in the other groups.
Caesarean Delivery
Number of Caesarean deliveries in the prediction group
Time frame: 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.
Time frame: 24 months
Feasibility of Ultrasound Labour Parameters
The outcome was the number of women who had all labour parameters measured by ultrasound.
Time frame: 24 months
This study aimed to firstly assess the feasibilty 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, we aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a predictive model for the outcome of labour.
| Milestone | Acceptability | Feasibility | Predictive Model |
|---|---|---|---|
| Started | 119 | 195 | 270 |
| Minimum recruitment | 42 | 100 | 270 |
| Completed | 119 | 195 | 269 |
| Not completed | 0 | 0 | 1 |
Number of Caesarean deliveries in the prediction group
| Participants | Acceptability | Feasibility | Predictive Model |
|---|---|---|---|
| Caesarean Delivery | — | — | 79 |
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.
| Participants | Acceptability | Feasibility | Predictive Model |
|---|---|---|---|
| Acceptability of Intrapartum Ultrasound | 104 | 0 | 0 |
The outcome was the number of women who had all labour parameters measured by ultrasound.
| Participants | Acceptability | Feasibility | Predictive Model |
|---|---|---|---|
| Feasibility of Ultrasound Labour Parameters | 0 | 168 | 0 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acceptability | 0/119 (0%) | 0/119 (0%) | 0/119 (0%) |
| Feasibility of the Study | 0/195 (0%) | 0/195 (0%) | 0/195 (0%) |
| Predictive Model | 0/270 (0%) | 0/270 (0%) | 0/270 (0%) |
| Age, Continuous(years) | Acceptability and Feasibilty | Feasibility | Predictive Model | Total |
|---|---|---|---|---|
| Median | 31.2 ± 5.3 | 31 ± 4.8 | 31.0 ± 5.1 | 31 ± 5.0 |
| Sex: Female, Male(Participants) | Acceptability and Feasibilty | Feasibility | Predictive Model | Total |
|---|---|---|---|---|
| Female | 119 | 195 | 270 | 584 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Acceptability and Feasibilty | Feasibility | Predictive Model | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 119 | 195 | 270 | 584 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Regional analgesia(Participants) | Acceptability and Feasibilty | Feasibility | Predictive Model | Total |
|---|---|---|---|---|
| Count of participants | 95 | 178 | 211 | 484 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Apr 2015, a primary completion of Jan 2018 and a completion of Jan 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2024, 6 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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