Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 6:30 AM
Study NCT ID:
NCT05123560
Status:
UNKNOWN
Last Update Posted:
2022-03-09
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Women's Perspective on First-trimester Preeclampsia Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception on information prior to the appointment to screen', 'timeFrame': '11-14 weeks of pregnancy', 'description': "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."}, {'measure': 'Perception on information received the day of the screening', 'timeFrame': '11-14 weeks of pregnancy', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Anxiety and stress related to the results of the preeclampsia screening', 'timeFrame': '11-14 weeks of pregnancy', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preeclampsia screening', 'First-trimester', "Women's perception", 'Anxiety', 'Stress', 'Clinical practice'], 'conditions': ["Woman's Role", 'Preeclampsia', 'Screening']}, 'referencesModule': {'references': [{'pmid': '28657417', 'type': 'BACKGROUND', '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."}, {'pmid': '28067011', 'type': 'BACKGROUND', '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."}, {'pmid': '28887883', 'type': 'BACKGROUND', '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. No abstract available."}, {'pmid': '25156501', 'type': 'BACKGROUND', 'citation': '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': '27974943', 'type': 'BACKGROUND', '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."}, {'pmid': '24631382', 'type': 'BACKGROUND', 'citation': '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': '22994561', 'type': 'BACKGROUND', 'citation': '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': '2282225', 'type': 'BACKGROUND', 'citation': "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': '19100148', 'type': 'BACKGROUND', 'citation': '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': '30487901', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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).\n\nWomen'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.", 'detailedDescription': "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.\n\nWomen'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.\n\nScreening 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant women with a singleton pregnancy attending their first-trimester ultrasound and undergoing preeclampsia screening', 'genderDescription': 'this study is only for pregnant women, regardless of their gender perceived identity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older that 18 years old\n* singleton pregnancy\n* low risc of cromosomal abnormalities (\\<1/1100)\n* normal first trimester ultrasound (no evidence of fetal malformations)\n\nExclusion Criteria:\n\n\\- Pacients will diagnosed mental disorders (including depression and anxiaety disorder)'}, 'identificationModule': {'nctId': 'NCT05123560', 'briefTitle': "Women's Perspective on First-trimester Preeclampsia Screening", 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': "First-trimester Preeclampsia Screening: Women's Perspectives", 'orgStudyIdInfo': {'id': 'IIBSP-PRE-2021-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women attending first-trimester ultrasound', 'description': 'All women attending their first-trimester ultrasound and meeting the inclusion criteria will be invited to participate', 'interventionNames': ['Other: Anonymous online questionnaire']}], 'interventions': [{'name': 'Anonymous online questionnaire', 'type': 'OTHER', 'description': 'A QR code qill be provided to access the online questionnaire', 'armGroupLabels': ['women attending first-trimester ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigador', 'investigatorFullName': 'Cristina Trilla', 'investigatorAffiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}}}}