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

NCT06322771 | Completed

• 1 other identifier: APHP240376
• Study Type: observational
• Target: 472
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Refusal; Clinical trial; Factors; Reasons; Pregnancy; Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of acceptations

  Day 1

• Number of refusals

  Day 1

• Demographic characteristics

  Day 1

• Questionnaire "acceptance"

  Day 1

• Questionnaire "refusal"

  Day 1

Study Arms (2)

Refusal

A questionnaire will be given to patients who have refused to participate in the RANSPRE trial

Behavioral: Questionnaire

Acceptance

A questionnaire will be given to patients who have agreed to participate in the RANSPRE trial

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaire about acceptance

Acceptance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Any pregnant woman is eligible if:
• monofetal pregnancy
• between 11 and 14 weeks
• legal age
• health insurance coverage

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Port-Royal Maternity

Paris, IDF, 75014, France

Location

MeSH Terms

Conditions

Treatment Refusal; Pre-Eclampsia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Yoann Athiel, MD

  Port-Royal Maternity - APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: April 11, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)