PreeclampsiaPRERETRONCT04658966
Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia.
An observational study of Preeclampsia, run by University Hospital, Brest at 1 site in France.
Trial summary
PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital. 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
- Preeclampsia
- What is being tested?
- administration of a self-questionnaire
- How many people
- 207 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to 22 Jun 2021
- 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: Cases will be women with a history of pre-eclampsia before 2015 and controls will be women with no history of hypertensive disorder during pregnancy.
Who may be able to join
- Women who gave birth after a pregnancy of more than 6 months at Brest University Hospital between January 2002 and December 2014
- For the cases: with a pre-eclampsia diagnosis during pregnancy
- For the controls: with no history of hypertensive disorder during pregnancy
Who cannot join
- Women Under legal protection
- Women unable to read French
- Medical interruption of pregnancy
- Pregnancy with a delivery before 6 months
- Women who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia of More Than 5 Years in Women Who Have Already Had a Pregnancy of More Than 6 Months With Childbirth at Brest University Hospital.
PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital.
Read the detailed description
This study will help to evaluate the specificity and sensitivity of the French translation of a self-questionnaire looking for a history of pre-eclampsia in women who gave birth at Brest University Hospital before year 2015.
First, women with pre-eclampsia (cases) and women with no hypertensive disorders (controls) during pregnancy were identified with the Medical Registry Database (MRD) of Brest University maternity ward.
All pre-eclampsia diagnoses were reviewed by 2 experts in order to confirm the accuracy of the diagnosis.
250 cases and 250 controls were finally selected after consultation of their medical file and were pre-included in the study.
Then, the 500 women will be contacted by phone or e-mail in order to inform them about the study and to offer them the possibility to participate in the study.
The women who will agree to participate in the study will fill in an online self-questionnaire on pre-eclampsia.
Their responses will then be compared to the diagnosis retained after consultation of their medical file.
Sensitivity and specificity of the questionnaire will then be evaluated.
- Conditions
- Preeclampsia
- Being tested
- administration of a self-questionnaire
- Keywords
- questionnaire
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of a self-questionnaireOther
Women will have to fill in an online self questionnaire on pre-eclampsia
| Study group | Role | What they receive |
|---|---|---|
| cases | Women with a history of pre-eclampsia Receives: Other: administration of a self-questionnaire | |
| controls | Women with no history of hypertensive disorder during pregnancy Receives: Other: administration of a self-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate diagnostic sensitivity and specificity of the self questionnaire
Presence or not of a history pre-eclampsia according to responses to the questionnaire
Measured: Inclusion ( Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start18 Sep 2020
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658966
- Sponsor's protocol ID
- PRERETRO ( 29BRC20.0133)
- Acronym
- PRERETRO
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Societe francaise d'anesthesie et de reanimation (Sfar); College national des gynecologues et obstetriciens francais (CNGOF); Societe francaise de medecine perinatale (SFMP); Societe francaise de neonatalogie (SFNN). [Multidisciplinary management of severe pre-eclampsia (PE). Experts' guidelines 2008. Societe francaise d'anesthesie et de reanimation. College national des gynecologues et obstetriciens francais. Societe francaise de medecine perinatale. Societe francaise de neonatalogie]. Ann Fr Anesth Reanim. 2009 Mar;28(3):275-81. doi: 10.1016/j.annfar.2009.02.015. Epub 2009 Mar 24. No abstract available. French.
PubMed 19321292Saucedo M, Deneux-Tharaux C, Bouvier-Colle MH; Le Comite national d'experts sur la mortalite maternelle. [Maternal mortality in France, 2007-2009]. J Gynecol Obstet Biol Reprod (Paris). 2013 Nov;42(7):613-27. doi: 10.1016/j.jgyn.2013.06.011. Epub 2013 Sep 13. French.
PubMed 24035736Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1.
PubMed 17975258van Wyk L, van der Marel J, Schuerwegh AJ, Schouffoer AA, Voskuyl AE, Huizinga TW, Bianchi DW, Scherjon SA. Increased incidence of pregnancy complications in women who later develop scleroderma: a case control study. Arthritis Res Ther. 2011;13(6):R183. doi: 10.1186/ar3510. Epub 2011 Nov 4.
PubMed 22053948Kamper-Jorgensen M, Gammill HS, Nelson JL. Preeclampsia and scleroderma: a prospective nationwide analysis. Acta Obstet Gynecol Scand. 2018 May;97(5):587-590. doi: 10.1111/aogs.13296. Epub 2018 Feb 8.
PubMed 29344946Diehl CL, Brost BC, Hogan MC, Elesber AA, Offord KP, Turner ST, Garovic VD. Preeclampsia as a risk factor for cardiovascular disease later in life: validation of a preeclampsia questionnaire. Am J Obstet Gynecol. 2008 May;198(5):e11-3. doi: 10.1016/j.ajog.2007.09.038. Epub 2008 Feb 1.
PubMed 18241822
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia of More Than 5 Years in Women Who Have Already Had a Pregnancy of More Than 6 Months With Childbirth at Brest University Hospital.
- ClinicalTrials.gov ID
- NCT04658966
- Acronym / sponsor ID
- PRERETRO / PRERETRO ( 29BRC20.0133)
- Conditions
- Preeclampsia
- Keywords
- questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 9 Dec 2020 (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.
PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital.
Detailed description
This study will help to evaluate the specificity and sensitivity of the French translation of a self-questionnaire looking for a history of pre-eclampsia in women who gave birth at Brest University Hospital before year 2015.
First, women with pre-eclampsia (cases) and women with no hypertensive disorders (controls) during pregnancy were identified with the Medical Registry Database (MRD) of Brest University maternity ward.
All pre-eclampsia diagnoses were reviewed by 2 experts in order to confirm the accuracy of the diagnosis.
250 cases and 250 controls were finally selected after consultation of their medical file and were pre-included in the study.
Then, the 500 women will be contacted by phone or e-mail in order to inform them about the study and to offer them the possibility to participate in the study.
The women who will agree to participate in the study will fill in an online self-questionnaire on pre-eclampsia.
Their responses will then be compared to the diagnosis retained after consultation of their medical file.
Sensitivity and specificity of the questionnaire will then be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: administration of a self-questionnaireWomen with a history of pre-eclampsia |
| controls | – | Other: administration of a self-questionnaireWomen with no history of hypertensive disorder during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be women with a history of pre-eclampsia before 2015 and controls will be women with no history of hypertensive disorder during pregnancy.
Key inclusion criteria (3 listed)
- Women who gave birth after a pregnancy of more than 6 months at Brest University Hospital between January 2002 and December 2014
- For the cases: with a pre-eclampsia diagnosis during pregnancy
- For the controls: with no history of hypertensive disorder during pregnancy
Key exclusion criteria (5 listed)
- Women Under legal protection
- Women unable to read French
- Medical interruption of pregnancy
- Pregnancy with a delivery before 6 months
- Women who refused to participate in the study
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 |
|---|---|---|
| administration of a self-questionnaireWomen will have to fill in an online self questionnaire on pre-eclampsia | Other | cases, controls |
Primary outcome
Evaluate diagnostic sensitivity and specificity of the self questionnaire
Time frame: Inclusion ( Day 0)
Presence or not of a history pre-eclampsia according to responses to the questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Results publication: PubMed 19321292Societe francaise d'anesthesie et de reanimation (Sfar); College national des gynecologues et obstetriciens francais (CNGOF); Societe francaise de medecine perinatale (SFMP); Societe francaise de neonatalogie (SFNN). [Multidisciplinary management of severe pre-eclampsia (PE). Experts' guidelines 2008. Societe francaise d'anesthesie et de reanimation. College national des gynecologues et obstetriciens francais. Societe francaise de medecine perinatale. Societe francaise de neonatalogie]. Ann Fr Anesth Reanim. 2009 Mar;28(3):275-81. doi: 10.1016/j.annfar.2009.02.015. Epub 2009 Mar 24. No abstract available. French.
- Results publication: PubMed 24035736Saucedo M, Deneux-Tharaux C, Bouvier-Colle MH; Le Comite national d'experts sur la mortalite maternelle. [Maternal mortality in France, 2007-2009]. J Gynecol Obstet Biol Reprod (Paris). 2013 Nov;42(7):613-27. doi: 10.1016/j.jgyn.2013.06.011. Epub 2013 Sep 13. French.
- Results publication: PubMed 17975258Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1.
- Results publication: PubMed 22053948van Wyk L, van der Marel J, Schuerwegh AJ, Schouffoer AA, Voskuyl AE, Huizinga TW, Bianchi DW, Scherjon SA. Increased incidence of pregnancy complications in women who later develop scleroderma: a case control study. Arthritis Res Ther. 2011;13(6):R183. doi: 10.1186/ar3510. Epub 2011 Nov 4.
- Results publication: PubMed 29344946Kamper-Jorgensen M, Gammill HS, Nelson JL. Preeclampsia and scleroderma: a prospective nationwide analysis. Acta Obstet Gynecol Scand. 2018 May;97(5):587-590. doi: 10.1111/aogs.13296. Epub 2018 Feb 8.
- Results publication: PubMed 18241822Diehl CL, Brost BC, Hogan MC, Elesber AA, Offord KP, Turner ST, Garovic VD. Preeclampsia as a risk factor for cardiovascular disease later in life: validation of a preeclampsia questionnaire. Am J Obstet Gynecol. 2008 May;198(5):e11-3. doi: 10.1016/j.ajog.2007.09.038. Epub 2008 Feb 1.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Preeclampsia (PE)
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 Preeclampsia, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Feb 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate diagnostic sensitivity and specificity of the self questionnaire (time frame: Inclusion ( Day 0)). 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 NCT04658966, which also lists 6 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 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.