Women's Perspective on First-trimester Preeclampsia Screening

Preeclampsia Clinical Trial

Official title:

First-trimester Preeclampsia Screening: Women's Perspectives

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05123560
• Other study ID #: IIBSP-PRE-2021-23
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: December 31, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia
• Screening
• Woman's Role

Intervention

Other:
• Anonymous online questionnaire
A QR code qill be provided to access the online questionnaire

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

Buela-Casal G, Guillén-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. — View Citation

Fernández San Martín MI, Rebagliato Nadal O, de Gispert Uriach B, Roig Carrera H, Artigas Guix J, Bonay Valls B, Guix Font L, Turmo Tristán N. [Adaptation of a patient satisfaction questionnaire on medical and nursing care]. Aten Primaria. 2008 Dec;40(12):611-6. Spanish. — View Citation

Jørgensen 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. — View Citation

Jørgensen 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. — View Citation

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. — View Citation

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. Erratum in: Ultrasound Obstet Gynecol. 2017 Dec;50(6):807. — View Citation

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. — View Citation

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. — View Citation

Simeone S, Lojo C, Garcia-Esteve L, Triunfo S, Crovetto F, Arranz A, Gratacós 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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