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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.
Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
Comparison of demographic characteristics between the two groups
Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refusal | A questionnaire will be given to patients who have refused to participate in the RANSPRE trial |
| |
| Acceptance | A questionnaire will be given to patients who have agreed to participate in the RANSPRE trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Questionnaire about acceptance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Factors associated with women's refusal | The primary objective is to assess whether there are factors associated with women's refusal to participate in the RANSPRE randomized clinical trial. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of acceptations | Day 1 | |
| Number of refusals | Day 1 | |
| Demographic characteristics |
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Inclusion Criteria :
Inclusion criteria are the same as for the RANSPRE trial.
Any pregnant woman is eligible if:
Exclusion Criteria :
Inclusion criteria are the same as for the RANSPRE trial. A history of pre-eclampsia in a previous pregnancy and a contraindication to aspirin are non-inclusion criteria.
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Women identified and eligible to participate in the RANSPRE trial within the Port-Royal maternity ward and having their T1 ultrasound scan within the maternity ward will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Yoann Athiel, MD | Port-Royal Maternity - APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Port-Royal Maternity | Paris | IDF | 75014 | France |
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| Questionnaire |
| Behavioral |
Questionnaire about refusal |
|
| Day 1 |
| Questionnaire "acceptance" | Evaluation of motivations linked to acceptance (based on the questionnaire given to women who agree to participate) The secondary objective is to qualitatively assess the reasons for acceptance of participation. | Day 1 |
| Questionnaire "refusal" | Evaluation of the reasons for refusing to participate - obstacles (based on the questionnaire given to women who refuse to participate). The secondary objective is to qualitatively assess the reasons for refusal of participation. | Day 1 |
| ID | Term |
|---|---|
| D016312 | Treatment Refusal |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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