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Clinical Trials/NCT05123560
NCT05123560
Unknown
Not Applicable

First-trimester Preeclampsia Screening: Women's Perspectives

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country750 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Woman's Role
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
750
Locations
1
Primary Endpoint
Perception on information prior to the appointment to screen
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to evaluate women's perception on first-trimester preeclampsia screening as it is performed currently in daily practice. Thus, the investigators will assess the degree of satisfaction regarding the information received previously to the date of screening, and on the same day the screening is performed (at the time of first-trimester scan).

Women's unsderstanding regarding preeclampsia screening will be evaluated by means of an anonymous online questionnaire. Anxiety and stress related to the results will also be assessed.

Detailed Description

Preeclampsia screening was established in Catalonia in 2018. However, little training for professionals (doctors and midwifes) was performed. Women's opinion regarding screening was not asked prior to its implementation, and most women no dot receive any information prior to be screened. Women's opinion on their pregnancy follow-ups is important, but this aspect is often not included in clinical practice policies. Thus, the objective of the study is to evaluate women's perception regarding current clinical practice in screening of preeclampsia, and their degree of satisfaction. Screening and risk-assessments during pregnancy are also a potential cause of stress for women. Anxiety and stress regarding preeclampsia screening results will also be evaluated.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party
Principal Investigator
Principal Investigator

Cristina Trilla

Principal investigador

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Eligibility Criteria

Inclusion Criteria

  • Older that 18 years old
  • singleton pregnancy
  • low risc of cromosomal abnormalities (\<1/1100)
  • normal first trimester ultrasound (no evidence of fetal malformations)

Exclusion Criteria

  • Pacients will diagnosed mental disorders (including depression and anxiaety disorder)

Outcomes

Primary Outcomes

Perception on information prior to the appointment to screen

Time Frame: 11-14 weeks of pregnancy

Number of Participants with a high satisfaction degree with the received information prior to screening assessed by Baker's questionnaire. Answers to Baker's questionnaire: 1) Strongly agree 2) Somewhat agree 3) Neither agree nor disagree 4) Somewhat disagree 5) Strongly disagree. None of the answers mean a better or worse outcome. The aim is to record and characterize women's perception.

Perception on information received the day of the screening

Time Frame: 11-14 weeks of pregnancy

Number of Participants with a high satisfaction degree with the received information the day of the screening assessed by Baker's questionnaire. Answers to Baker's questionnaire: 1) Strongly agree 2) Somewhat agree 3) Neither agree nor disagree 4) Somewhat disagree 5) Strongly disagree. None of the answers mean a better or worse outcome. The aim is to record and characterize women's perception.

Secondary Outcomes

  • Anxiety and stress related to the results of the preeclampsia screening(11-14 weeks of pregnancy)

Study Sites (1)

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