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 pregnancy and childbirth in France. 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 about acceptance
Questionnaire about acceptance
BEHAVIORALQuestionnaire about refusal
Questionnaire about refusal
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of maternal demographic characteristics | Day 1 | 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. |
| Collection of obstetric characteristics | Day 1 | 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. |
| Collection of characteristics related to information provided | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation linked to acceptance | Day 1 | Evaluation of motivation linked to acceptance (based on the questionnaire given to women who agree to participate). No score, it is a qualitative analyse. |
| Reason for refusing to participate | Day 1 | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORYoann Athiel, MD
Port-Royal Maternity - APHP
Outcome results
None listed