Women's Perspective on First-trimester Preeclampsia Screening
NCT ID: NCT05123560
Last Updated: 2022-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
750 participants
OBSERVATIONAL
2022-04-01
2022-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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women attending first-trimester ultrasound
All women attending their first-trimester ultrasound and meeting the inclusion criteria will be invited to participate
Anonymous online questionnaire
A QR code qill be provided to access the online questionnaire
Interventions
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Anonymous online questionnaire
A QR code qill be provided to access the online questionnaire
Eligibility Criteria
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Inclusion Criteria
* singleton pregnancy
* low risc of cromosomal abnormalities (\<1/1100)
* normal first trimester ultrasound (no evidence of fetal malformations)
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Cristina Trilla
Principal investigador
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IIBSP-PRE-2021-23
Identifier Type: -
Identifier Source: org_study_id
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