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OpenTrials
Completed

NCT Number: NCT06322771

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

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.

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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

Port-Royal Maternity

Paris, IDF, 75014, France

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

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

Inclusion criteria

Inclusion criteria

are the same as for the RANSPRE trial.

Any pregnant woman is eligible if:

  • monofetal pregnancy
  • between 11 and 14 weeks
  • legal age
  • health insurance coverage

Exclusion criteria

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.

Treatment and study plan

Questionnaire

Behavioral

Questionnaire about acceptance

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of acceptations

    Time frame: Day 1

  2. Number of refusals

    Time frame: Day 1

  3. Demographic characteristics

    Time frame: Day 1

  4. Questionnaire "acceptance"

    Time frame: Day 1

    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.

  5. Questionnaire "refusal"

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: RANSPRE-refus

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2024
Registry last updated
Sep 15, 2025

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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