Pregnancy RelatedRANSPRE-refusNCT06322771
Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal
An observational study of Pregnancy Related, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 472 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: 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.
Who may be able to join
- Any pregnant woman is eligible if:
- monofetal pregnancy
- between 11 and 14 weeks
- legal age
- health insurance coverage
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
- Comparison of demographic characteristics between the two groups
- Group 1: women accepting to participate in RCT
- Group 2: women refusing to participate in RCT
- 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).
- Conditions
- Pregnancy Related
- Being tested
- Questionnaire
- Keywords
- Refusal, Clinical trial, Factors, Reasons, Pregnancy, Pre-eclampsia
- Medical subject headings
- Treatment Refusal, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire about acceptance
QuestionnaireBehavioural
Questionnaire about refusal
| Study group | Role | What they receive |
|---|---|---|
| Refusal | A questionnaire will be given to patients who have refused to participate in the RANSPRE trial Receives: Behavioral: Questionnaire | |
| Acceptance | A questionnaire will be given to patients who have agreed to participate in the RANSPRE trial Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (5)
Number of acceptations
Measured: Day 1
Number of refusals
Measured: Day 1
Demographic characteristics
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start11 Apr 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yoann Athiel, MD, Principal investigator, Port-Royal Maternity - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322771
- Sponsor's protocol ID
- APHP240376
- Acronym
- RANSPRE-refus
- Status last verified
- Sep 2025
- First submitted
- 14 Mar 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal
- ClinicalTrials.gov ID
- NCT06322771
- Acronym / sponsor ID
- RANSPRE-refus / APHP240376
- Conditions
- Pregnancy Related
- Keywords
- Refusal, Clinical trial, Factors, Reasons, Pregnancy, Pre-eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
- Comparison of demographic characteristics between the two groups
- Group 1: women accepting to participate in RCT
- Group 2: women refusing to participate in RCT
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refusal | – | Behavioral: QuestionnaireA questionnaire will be given to patients who have refused to participate in the RANSPRE trial |
| Acceptance | – | Behavioral: QuestionnaireA questionnaire will be given to patients who have agreed to participate in the RANSPRE trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- monofetal pregnancy
- between 11 and 14 weeks
- legal age
- health insurance coverage
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire about acceptance | Behavioural | Acceptance |
| QuestionnaireQuestionnaire about refusal | Behavioural | Refusal |
Primary outcome
Factors associated with women's refusal
Time frame: 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.
5 secondary outcomes
Number of acceptations
Time frame: Day 1
Number of refusals
Time frame: Day 1
Demographic characteristics
Time frame: Day 1
Questionnaire "acceptance"
Time frame: Day 1
Questionnaire "refusal"
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoann Athiel, MD principal investigator
Port-Royal Maternity - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with women's refusal (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.