Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated With Refusal and Reasons for Refusal and Acceptance

NCT06612320 | Completed

• 1 other identifier: APHP240778
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 4

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.

Conditions

Pregnancy Related

Keywords

Refusal; clinical trial; factors; reasons; pregnancy; pre-eclampsia

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Motivation linked to acceptance

  Day 1

• Reason for refusing to participate

  Day 1

Study Arms (2)

Acceptance

Women who accept to participate to a Randomized Controlled Trial (RCT)

Behavioral: Questionnaire about acceptance

Refusal

Women who refuse to participate to a Randomized Controlled Trial (RCT)

Behavioral: Questionnaire about refusal

Interventions

Questionnaire about acceptance BEHAVIORAL

Questionnaire about acceptance

Acceptance

Questionnaire about refusal BEHAVIORAL

Questionnaire about refusal

Refusal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (4)

APHP - Antoine Béclère hospital - Maternity

Clamart, IDF, 92140, France

Location

APHP - Louis Mourier hospital - Maternity

Colombes, IDF, 92700, France

Location

APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity

Paris, IDF, 75010, France

Location

APHP - Port-Royal Maternity

Paris, IDF, 75014, France

Location

MeSH Terms

Conditions

Treatment Refusal; Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

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: September 6, 2024
• First Posted: September 25, 2024
• Study Start: October 31, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)