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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 pregnancy and childbirth in France. 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 |
|---|---|---|---|
| Acceptance | Women who accept to participate to a Randomized Controlled Trial (RCT) |
| |
| Refusal | Women who refuse to participate to a Randomized Controlled Trial (RCT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire about acceptance | Behavioral | Questionnaire about acceptance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of maternal demographic characteristics | Age, level of education, profession, geographic origin, health insurance/mutual, marital status The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse. | Day 1 |
| Collection of obstetric characteristics | Parity, obstetric history (first-trimester pregnancy loss, IUFD, perinatal death), pregnancy complications, gestational age… The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse. | Day 1 |
| Collection of characteristics related to information provided | By whom? , with whom? (impact of the companion), when? The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation linked to acceptance | Evaluation of motivation linked to acceptance (based on the questionnaire given to women who agree to participate). No score, it is a qualitative analyse. | Day 1 |
| Reason for refusing to participate |
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Inclusion Criteria:
The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.
Exclusion Criteria:
None
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The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.
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| Name | Affiliation | Role |
|---|---|---|
| Yoann Athiel, MD | Port-Royal Maternity - APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP - Antoine Béclère hospital - Maternity | Clamart | IDF | 92140 | France | ||
| APHP - Louis Mourier hospital - Maternity |
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| Questionnaire about refusal |
| Behavioral |
Questionnaire about refusal |
|
Evaluation of the reason for refusing to participate (based on the questionnaire given to women who refuse to participate)
No score, it is a qualitative analyse.
| Day 1 |
| Colombes |
| IDF |
| 92700 |
| France |
| APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity | Paris | IDF | 75010 | France |
| APHP - Port-Royal Maternity | Paris | IDF | 75014 | France |
| 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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