Woman's RoleNCT05123560
Women's Perspective on First-trimester Preeclampsia Screening
An observational study of Woman's Role and Preeclampsia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Woman's Role, Preeclampsia, Screening
- What is being tested?
- Anonymous online questionnaire
- How many people
- 750 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnant women with a singleton pregnancy attending their first-trimester ultrasound and undergoing preeclampsia screening
Who may be able to join
- Older that 18 years old
- singleton pregnancy
- low risc of cromosomal abnormalities (<1/1100)
- normal first trimester ultrasound (no evidence of fetal malformations)
Who cannot join
- Pacients will diagnosed mental disorders (including depression and anxiaety disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Woman's Role, Preeclampsia, Screening
- Being tested
- Anonymous online questionnaire
- Keywords
- Preeclampsia screening, First-trimester, Women's perception, Anxiety, Stress, Clinical practice
- Medical subject headings
- Pre-Eclampsia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anonymous online questionnaireOther
A QR code qill be provided to access the online questionnaire
| Study group | Role | What they receive |
|---|---|---|
| women attending first-trimester ultrasound | All women attending their first-trimester ultrasound and meeting the inclusion criteria will be invited to participate Receives: Other: Anonymous online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 11-14 weeks of pregnancy
Secondary outcomes (1)
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.
Measured: 11-14 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Apr 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Woman's RoleStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Trilla, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123560
- Sponsor's protocol ID
- IIBSP-PRE-2021-23
- Status last verified
- Mar 2022
- First submitted
- 8 Oct 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28657417O'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.
PubMed 28067011Rolnik 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.
PubMed 28887883Simeone 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.
PubMed 25156501Luchian B, Neagu M, Luchian L, Vladareanu R. Preeclampsia screening from the patient's perspective. J Med Life. 2016 Jul-Sep;9(3):321-323.
PubMed 27974943Jorgensen 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.
PubMed 24631382Jorgensen 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.
PubMed 22994561Baker R. Development of a questionnaire to assess patients' satisfaction with consultations in general practice. Br J Gen Pract. 1990 Dec;40(341):487-90.
PubMed 2282225Fernandez 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.
PubMed 19100148Buela-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.
PubMed 30487901
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-trimester Preeclampsia Screening: Women's Perspectives
- ClinicalTrials.gov ID
- NCT05123560
- Acronym / sponsor ID
- IIBSP-PRE-2021-23
- Conditions
- Woman's Role, Preeclampsia, Screening
- Keywords
- Preeclampsia screening, First-trimester, Women's perception, Anxiety, Stress, Clinical practice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women attending first-trimester ultrasound | – | Other: Anonymous online questionnaireAll women attending their first-trimester ultrasound and meeting the inclusion criteria will be invited to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women with a singleton pregnancy attending their first-trimester ultrasound and undergoing preeclampsia screening
Key inclusion criteria (4 listed)
- Older that 18 years old
- singleton pregnancy
- low risc of cromosomal abnormalities (<1/1100)
- normal first trimester ultrasound (no evidence of fetal malformations)
Key exclusion criteria (1 listed)
- Pacients will diagnosed mental disorders (including depression and anxiaety disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anonymous online questionnaireA QR code qill be provided to access the online questionnaire | Other | women attending first-trimester ultrasound |
Primary outcome
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.
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.
1 secondary outcome
Anxiety and stress related to the results of the preeclampsia screening
Time frame: 11-14 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 28657417Rolnik 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.
- Background: PubMed 28067011O'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.
- Background: PubMed 28887883Rolnik 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.
- Background: PubMed 25156501Simeone 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.
- Background: PubMed 27974943Luchian B, Neagu M, Luchian L, Vladareanu R. Preeclampsia screening from the patient's perspective. J Med Life. 2016 Jul-Sep;9(3):321-323.
- Background: PubMed 24631382Jorgensen 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.
- Background: PubMed 22994561Jorgensen 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.
- Background: PubMed 2282225Baker R. Development of a questionnaire to assess patients' satisfaction with consultations in general practice. Br J Gen Pract. 1990 Dec;40(341):487-90.
- Background: PubMed 19100148Fernandez 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.
- Background: PubMed 30487901Buela-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Woman's Role and Preeclampsia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception on information prior to the appointment to screen (time frame: 11-14 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123560, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.