Peripartum PeriodNCT05191251
Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire
An observational study of Peripartum Period and Hemorrhage, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The diagnostic performance of the HEMSTOP (Hematoma, hEmorrhage, Menorrhagia, Surgery, Tooth extraction, Obstetrics, Parents) standardized questionnaire collected during the preoperative anesthesia consultation in order to detect a deficit in hemostasis associated with the risk of hemorrhage in pregnant women will be… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripartum Period, Hemorrhage, HEMSTOP Questionnaire
- What is being tested?
- HEMSTOP questionnaire
- How many people
- 3,588 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jan 2022to 30 Jun 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
- Adult, Older adult
Study population: Full-term pregnant women
Who may be able to join
- Full-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation.
- Patients who received follow-up during pregnancy as recommended. Age over 18
Who cannot join
- Patients age under the age of 18 Patients who did not have follow-up during pregnancy as recommended Patients taking long-term anticoagulants and/or antiaggregants Patients with a language barrier
Trial locations and contacts
1 site in 1 country.
About this study
The diagnostic performance of the HEMSTOP (Hematoma, hEmorrhage, Menorrhagia, Surgery, Tooth extraction, Obstetrics, Parents) standardized questionnaire collected during the preoperative anesthesia consultation in order to detect a deficit in hemostasis associated with the risk of hemorrhage in pregnant women will be analyzed. The primary aim of the study is to assess the sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests. The second aim of the study is to assess the sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage.
- Conditions
- Peripartum Period, Hemorrhage, HEMSTOP Questionnaire
- Being tested
- HEMSTOP questionnaire
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMSTOP questionnaireDiagnostic test
A HEMSTOP questionnaire is obtained during the anesthesia consultation.
| Study group | Role | What they receive |
|---|---|---|
| Full-term pregnant women with HEMSTOP | Full-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation.
Patients who received follow-up during pregnancy as recommended. Age over 18 Receives: Diagnostic Test: HEMSTOP questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity lab tests
Sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests will be calculated.
Firstline hemostasis tests are aPTT, PT, INR, fibrinogen level and platelet count.
Measured: 24 hours
Secondary outcomes (1)
Sensitivity and specificity hemorrhage
Sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage will be assessed.
Postpartum hemorraghe is defined as blood loss greater then 500 mL for vaginal deliveries and greater than 1000 mL for cesarean sections.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start13 Jan 2022
- Primary completion10 Jun 2022
- Study completion30 Jun 2022
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 Peripartum PeriodStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191251
- Sponsor's protocol ID
- CHUB-MAT-HEMSTOP
- Status last verified
- Jul 2022
- First submitted
- 29 Dec 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonhomme F, Boehlen F, Clergue F, de Moerloose P. Preoperative hemostatic assessment: a new and simple bleeding questionnaire. Can J Anaesth. 2016 Sep;63(9):1007-15. doi: 10.1007/s12630-016-0688-9. Epub 2016 Jul 1.
PubMed 27369959Bonhomme F, Ajzenberg N, Schved JF, Molliex S, Samama CM; French Anaesthetic and Intensive Care Committee on Evaluation of Routine Preoperative Testing; French Society of Anaesthesia and Intensive Care. Pre-interventional haemostatic assessment: Guidelines from the French Society of Anaesthesia and Intensive Care. Eur J Anaesthesiol. 2013 Apr;30(4):142-62. doi: 10.1097/EJA.0b013e32835f66cd.
PubMed 23435255Hawkins JL. Obstetric Hemorrhage. Anesthesiol Clin. 2020 Dec;38(4):839-858. doi: 10.1016/j.anclin.2020.08.010. Epub 2020 Oct 15.
PubMed 33127031Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
PubMed 28937571Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PubMed 25103301Al-Zirqi I, Vangen S, Forsen L, Stray-Pedersen B. Prevalence and risk factors of severe obstetric haemorrhage. BJOG. 2008 Sep;115(10):1265-72. doi: 10.1111/j.1471-0528.2008.01859.x.
PubMed 18715412Butwick A, Lyell D, Goodnough L. How do I manage severe postpartum hemorrhage? Transfusion. 2020 May;60(5):897-907. doi: 10.1111/trf.15794. Epub 2020 Apr 22.
PubMed 32319687Hoyert DL, Minino AM. Maternal Mortality in the United States: Changes in Coding, Publication, and Data Release, 2018. Natl Vital Stat Rep. 2020 Jan;69(2):1-18.
PubMed 32510319Eckman MH, Erban JK, Singh SK, Kao GS. Screening for the risk for bleeding or thrombosis. Ann Intern Med. 2003 Feb 4;138(3):W15-24. doi: 10.7326/0003-4819-138-3-200302040-00011-w1.
PubMed 12558384Zec T, Schmartz D, Temmerman P, Fils JF, Ickx B, Bonhomme F, Van Der Linden P. Assessment of haemostasis in pregnant women: A retrospective evaluation of the diagnostic performance of the HEMSTOP standardised questionnaire. Eur J Anaesthesiol Intensive Care. 2024 Mar 15;3(2):e0050. doi: 10.1097/EA9.0000000000000050. eCollection 2024 Apr.
PubMed 39917607
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire
- ClinicalTrials.gov ID
- NCT05191251
- Acronym / sponsor ID
- CHUB-MAT-HEMSTOP
- Conditions
- Peripartum Period, Hemorrhage, HEMSTOP Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,588 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Jan 2022 (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 diagnostic performance of the HEMSTOP (Hematoma, hEmorrhage, Menorrhagia, Surgery, Tooth extraction, Obstetrics, Parents) standardized questionnaire collected during the preoperative anesthesia consultation in order to detect a deficit in hemostasis associated with the risk of hemorrhage in pregnant women will be analyzed. The primary aim of the study is to assess the sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests. The second aim of the study is to assess the sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-term pregnant women with HEMSTOP | – | Diagnostic Test: HEMSTOP questionnaireFull-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation. Patients who received follow-up during pregnancy as recommended. Age over 18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Full-term pregnant women
Key inclusion criteria (2 listed)
- Full-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation.
- Patients who received follow-up during pregnancy as recommended. Age over 18
Key exclusion criteria (1 listed)
- Patients age under the age of 18 Patients who did not have follow-up during pregnancy as recommended Patients taking long-term anticoagulants and/or antiaggregants Patients with a language barrier
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 |
|---|---|---|
| HEMSTOP questionnaireA HEMSTOP questionnaire is obtained during the anesthesia consultation. | Diagnostic test | Full-term pregnant women with HEMSTOP |
Primary outcome
Sensitivity and specificity lab tests
Time frame: 24 hours
Sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests will be calculated. Firstline hemostasis tests are aPTT, PT, INR, fibrinogen level and platelet count.
1 secondary outcome
Sensitivity and specificity hemorrhage
Time frame: 24 hours
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 20 Jul 2022.
- Background: PubMed 27369959Bonhomme F, Boehlen F, Clergue F, de Moerloose P. Preoperative hemostatic assessment: a new and simple bleeding questionnaire. Can J Anaesth. 2016 Sep;63(9):1007-15. doi: 10.1007/s12630-016-0688-9. Epub 2016 Jul 1.
- Background: PubMed 23435255Bonhomme F, Ajzenberg N, Schved JF, Molliex S, Samama CM; French Anaesthetic and Intensive Care Committee on Evaluation of Routine Preoperative Testing; French Society of Anaesthesia and Intensive Care. Pre-interventional haemostatic assessment: Guidelines from the French Society of Anaesthesia and Intensive Care. Eur J Anaesthesiol. 2013 Apr;30(4):142-62. doi: 10.1097/EJA.0b013e32835f66cd.
- Background: PubMed 33127031Hawkins JL. Obstetric Hemorrhage. Anesthesiol Clin. 2020 Dec;38(4):839-858. doi: 10.1016/j.anclin.2020.08.010. Epub 2020 Oct 15.
- Background: PubMed 28937571Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
- Background: PubMed 25103301Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- Background: PubMed 18715412Al-Zirqi I, Vangen S, Forsen L, Stray-Pedersen B. Prevalence and risk factors of severe obstetric haemorrhage. BJOG. 2008 Sep;115(10):1265-72. doi: 10.1111/j.1471-0528.2008.01859.x.
- Background: PubMed 32319687Butwick A, Lyell D, Goodnough L. How do I manage severe postpartum hemorrhage? Transfusion. 2020 May;60(5):897-907. doi: 10.1111/trf.15794. Epub 2020 Apr 22.
- Background: PubMed 32510319Hoyert DL, Minino AM. Maternal Mortality in the United States: Changes in Coding, Publication, and Data Release, 2018. Natl Vital Stat Rep. 2020 Jan;69(2):1-18.
- Background: PubMed 12558384Eckman MH, Erban JK, Singh SK, Kao GS. Screening for the risk for bleeding or thrombosis. Ann Intern Med. 2003 Feb 4;138(3):W15-24. doi: 10.7326/0003-4819-138-3-200302040-00011-w1.
- Derived from this study: PubMed 39917607Zec T, Schmartz D, Temmerman P, Fils JF, Ickx B, Bonhomme F, Van Der Linden P. Assessment of haemostasis in pregnant women: A retrospective evaluation of the diagnostic performance of the HEMSTOP standardised questionnaire. Eur J Anaesthesiol Intensive Care. 2024 Mar 15;3(2):e0050. doi: 10.1097/EA9.0000000000000050. eCollection 2024 Apr.
- 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 Peripartum Period and Hemorrhage, run by Brugmann University Hospital at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 20 Jul 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 Belgium. 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?
Sensitivity and specificity lab tests (time frame: 24 hours). 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 NCT05191251, 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 20 Jul 2022.