Women's Perspective on First-trimester Preeclampsia Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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First-trimester Preeclampsia Screening: Women's Perspectives

Conditions
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Woman's Role, Preeclampsia, Screening

Intervention / Treatment
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* Other: Anonymous online questionnaire


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women attending first-trimester ultrasound<br>All women attending their first-trimester ultrasound and meeting the inclusion criteria will be invited to participate | Other: Anonymous online questionnaire<br>* A QR code qill be provided to access the online questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception on information prior to the appointment to screen | 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. | 11-14 weeks of pregnancy | 
| Perception on information received the day of the screening | 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. | 11-14 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and stress related to the results of the preeclampsia screening | Number of Participants with high anxiety and stress levels after the screening assessed by short version of the State-Trait Anxiety Inventory (STAI). Answers to the STAI questionnaire: 1) Not at all 2) A little bit 3) Quite a bit 4) Extremely. Answers 1 and 2 suggest low stress levels and answers 3 and 4 suggest high stress levels. Final score to characterize stress levels will be obtained after considering all answers. | 11-14 weeks of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia screening, First-trimester, Women's perception, Anxiety, Stress, Clinical practice