Women's Perspective on First-trimester Preeclampsia Screening

March 8, 2022 updated by: Cristina Trilla, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

First-trimester Preeclampsia Screening: Women's Perspectives

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08026
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All pregnant women with a singleton pregnancy attending their first-trimester ultrasound and undergoing preeclampsia screening

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
11-14 weeks of pregnancy
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.
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
Time Frame: 11-14 weeks of pregnancy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

December 20, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-PRE-2021-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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