Women's Perspective on First-trimester Preeclampsia Screening

NCT05123560 | Unknown DMC

• 1 other identifier: IIBSP-PRE-2021-23
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Woman's Role; Preeclampsia; Screening

Keywords

Preeclampsia screening; First-trimester; Women's perception; Anxiety; Stress; Clinical practice

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Anxiety and stress related to the results of the preeclampsia screening

  11-14 weeks of pregnancy

Study Arms (1)

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

Interventions

Anonymous online questionnaire OTHER

A QR code qill be provided to access the online questionnaire

women attending first-trimester ultrasound

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: this study is only for pregnant women, regardless of their gender perceived identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Related Publications (10)

• Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

  PMID: 28657417 BACKGROUND

• O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, Wright A, Akolekar R, Cicero S, Janga D, Jani J, Molina FS, de Paco Matallana C, Papantoniou N, Persico N, Plasencia W, Singh M, Nicolaides KH. Accuracy of competing-risks model in screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation. Ultrasound Obstet Gynecol. 2017 Jun;49(6):751-755. doi: 10.1002/uog.17399. Epub 2017 May 14.

  PMID: 28067011 BACKGROUND

• Rolnik DL, O'Gorman N, Roberge S, Bujold E, Hyett J, Uzan S, Beaufils M, da Silva Costa F. Early screening and prevention of preterm pre-eclampsia with aspirin: time for clinical implementation. Ultrasound Obstet Gynecol. 2017 Nov;50(5):551-556. doi: 10.1002/uog.18899. No abstract available.

  PMID: 28887883 BACKGROUND

• Simeone S, Lojo C, Garcia-Esteve L, Triunfo S, Crovetto F, Arranz A, Gratacos E, Figueras F. Psychological impact of first-trimester prevention for preeclampsia on anxiety. Prenat Diagn. 2015 Jan;35(1):60-4. doi: 10.1002/pd.4485. Epub 2014 Sep 22.

  PMID: 25156501 BACKGROUND

• Luchian B, Neagu M, Luchian L, Vladareanu R. Preeclampsia screening from the patient's perspective. J Med Life. 2016 Jul-Sep;9(3):321-323.

  PMID: 27974943 BACKGROUND

• Jorgensen JM, Hedley PL, Gjerris M, Christiansen M. Including ethical considerations in models for first-trimester screening for pre-eclampsia. Reprod Biomed Online. 2014 May;28(5):638-43. doi: 10.1016/j.rbmo.2014.01.013. Epub 2014 Feb 7.

  PMID: 24631382 BACKGROUND

• Jorgensen JM, Hedley PL, Gjerris M, Christiansen M. Ethical issues related to screening for preeclampsia. Bioethics. 2014 Sep;28(7):360-7. doi: 10.1111/j.1467-8519.2012.02005.x. Epub 2012 Sep 20.

  PMID: 22994561 BACKGROUND

• Baker R. Development of a questionnaire to assess patients' satisfaction with consultations in general practice. Br J Gen Pract. 1990 Dec;40(341):487-90.

  PMID: 2282225 BACKGROUND

• Fernandez San Martin MI, Rebagliato Nadal O, de Gispert Uriach B, Roig Carrera H, Artigas Guix J, Bonay Valls B, Guix Font L, Turmo Tristan N. [Adaptation of a patient satisfaction questionnaire on medical and nursing care]. Aten Primaria. 2008 Dec;40(12):611-6. doi: 10.1016/s0212-6567(08)75694-4. Spanish.

  PMID: 19100148 BACKGROUND

• Buela-Casal G, Guillen-Riquelme A. Short form of the Spanish adaptation of the State-Trait Anxiety Inventory. Int J Clin Health Psychol. 2017 Sep-Dec;17(3):261-268. doi: 10.1016/j.ijchp.2017.07.003. Epub 2017 Aug 14.

  PMID: 30487901 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigador

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 17, 2021
• Study Start: April 1, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 31, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)