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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| KU Leuven | OTHER |
| Norwegian University of Science and Technology | OTHER |
| British Medical Association |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Caesarean Delivery | Number of Caesarean deliveries in the prediction group | 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. | 24 months |
| Feasibility of Ultrasound Labour Parameters | The outcome was the number of women who had all labour parameters measured by ultrasound. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Group 1: acceptability and feasibility group
Group 2: predictive model group
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Lees, MD MRCOG | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
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Recruitment start date 22/04/2015 Recruitment end date 19/01/2018
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acceptability | Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls |
| FG001 | Feasibility | Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls |
| FG002 | Predictive Model | Nulliparous term labouring women with cephalic presentation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acceptability and Feasibilty | Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls |
| BG001 | Feasibility | Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Caesarean Delivery | Number of Caesarean deliveries in the prediction group | Total number of Caesarean deliveries | Posted | Count of Participants | Participants | 24 months |
|
2 years
Adverse event definition in study protocol. No adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acceptability | To assess acceptability of intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Christoph Lees | Imperial College | 02083831000 | christoph.lees@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2015 | Dec 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| D052065 | Vaginismus |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| OTHER |
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| BG002 | Predictive Model | Nulliparous term labouring women with cephalic presentation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Regional analgesia | Count of Participants | Participants |
|
Nulliparous term labouring women with cephalic presentation |
|
|
| 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. | Only analysing patients in the acceptability arm for this primary outcome | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Primary | Feasibility of Ultrasound Labour Parameters | The outcome was the number of women who had all labour parameters measured by ultrasound. | The outcome was the number of women who had all labour parameters measured by ultrasound. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| 119 |
| 0 |
| 119 |
| 0 |
| 119 |
| EG001 | Feasibility of the Study | To assess if ultrasound can measure labour parameters where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls | 0 | 195 | 0 | 195 | 0 | 195 |
| EG002 | Predictive Model | Nulliparous term labouring women with cephalic presentation | 0 | 270 | 0 | 270 | 0 | 270 |
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| D010922 | Placenta Diseases |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000091662 | Genital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |