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OpenTrials
Completed

NCT Number: NCT06612320

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

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.

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Key information

Conditions

Pregnancy Related Behavior Female Urogenital Diseases and Pregnancy Complications Health Behavior Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Treatment Adherence and Compliance Treatment Refusal Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

APHP - Antoine Béclère hospital - Maternity, Clamart, IDF, France

Loading trial locations.

About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire about acceptance

Behavioral

Questionnaire about acceptance

Questionnaire about refusal

Behavioral

Questionnaire about refusal

Primary outcomes

  1. Collection of maternal demographic characteristics

    Time frame: 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.

  2. Collection of obstetric characteristics

    Time frame: 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.

  3. Collection of characteristics related to information provided

    Time frame: 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 outcomes

  1. Motivation linked to acceptance

    Time frame: 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.

  2. Reason for refusing to participate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: REFWIT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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