Pregnancy Related
Conditions
Keywords
Refusal, Clinical trial, Factors, Reasons, Pregnancy, Pre-eclampsia
Brief summary
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.
Detailed description
1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT. 2. Comparison of demographic characteristics between the two groups * Group 1: women accepting to participate in RCT * Group 2: women refusing to participate in RCT 3. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate) 4. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).
Interventions
BEHAVIORALQuestionnaire
Questionnaire about acceptance
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
: Inclusion criteria are the same as for the RANSPRE trial. Any pregnant woman is eligible if: * monofetal pregnancy * between 11 and 14 weeks * legal age * health insurance coverage
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Factors associated with women's refusal | Day 1 | The primary objective is to assess whether there are factors associated with women's refusal to participate in the RANSPRE randomized clinical trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of acceptations | Day 1 | — |
| Number of refusals | Day 1 | — |
| Demographic characteristics | Day 1 | — |
| Questionnaire acceptance | Day 1 | 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. |
| Questionnaire refusal | Day 1 | 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. |
Countries
France
Outcome results
None listed