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.
Group 1: acceptability and feasibility group
Group 2: predictive model group
Exclusion Criteria:
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 |
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Imperial College London