Clinical trial NCT05123560: Women's Perspective on First-trimester Preeclampsia Screening
Official title: First-trimester Preeclampsia Screening: Women's Perspectives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Woman's Role
Preeclampsia
Screening
Keywords: Preeclampsia screening
First-trimester
Women's perception
Anxiety
Stress
Clinical practice
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women with a singleton pregnancy attending their first-trimester ultrasound and undergoing preeclampsia screening

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.

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)

Primary outcomes:
measure: Perception on information prior to the appointment to screen
timeFrame: 11-14 weeks of pregnancy
measure: Perception on information received the day of the screening
timeFrame: 11-14 weeks of pregnancy
Secondary outcomes:
measure: Anxiety and stress related to the results of the preeclampsia screening
timeFrame: 11-14 weeks of pregnancy
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
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