Placenta Praevia, Vaginismus
Conditions
Keywords
transperineal ultrasound, labour, sonopartogram, prediction model
Brief 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.
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.
Interventions
None listed
Sponsors
Imperial College Healthcare NHS Trust
KU Leuven
Norwegian University of Science and Technology
British Medical Association
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caesarean Delivery | 24 months | Number of Caesarean deliveries in the prediction group |
| Acceptability of Intrapartum Ultrasound | 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 | 24 months | The outcome was the number of women who had all labour parameters measured by ultrasound. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
Recruitment start date 22/04/2015 Recruitment end date 19/01/2018
Participants by arm
| Arm | Count |
|---|---|
| Acceptability and Feasibilty Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls | 119 |
| Feasibility Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls | 195 |
| Predictive Model Nulliparous term labouring women with cephalic presentation | 270 |
| Total | 584 |
Baseline characteristics
| Characteristic | Acceptability and Feasibilty | Feasibility | Predictive Model | Total |
|---|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 5.3 | 31 years STANDARD_DEVIATION 4.8 | 31.0 years STANDARD_DEVIATION 5.1 | 31 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 195 Participants | 270 Participants | 584 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Regional analgesia | 95 Participants | 178 Participants | 211 Participants | 484 Participants |
| Sex: Female, Male Female | 119 Participants | 195 Participants | 270 Participants | 584 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 195 | 0 / 270 |
| other Total, other adverse events | 0 / 119 | 0 / 195 | 0 / 270 |
| serious Total, serious adverse events | 0 / 119 | 0 / 195 | 0 / 270 |
Outcome results
Primary
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
Population: Only analysing patients in the acceptability arm for this primary outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acceptability | Acceptability of Intrapartum Ultrasound | 104 Participants |
| Feasibility | Acceptability of Intrapartum Ultrasound | 0 Participants |
| Predictive Model | Acceptability of Intrapartum Ultrasound | 0 Participants |
Primary
Caesarean Delivery
Number of Caesarean deliveries in the prediction group
Time frame: 24 months
Population: Total number of Caesarean deliveries
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Predictive Model | Caesarean Delivery | 79 Participants |
Primary
Feasibility of Ultrasound Labour Parameters
The outcome was the number of women who had all labour parameters measured by ultrasound.
Time frame: 24 months
Population: The outcome was the number of women who had all labour parameters measured by ultrasound.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acceptability | Feasibility of Ultrasound Labour Parameters | 0 Participants |
| Feasibility | Feasibility of Ultrasound Labour Parameters | 168 Participants |
| Predictive Model | Feasibility of Ultrasound Labour Parameters | 0 Participants |