Pre-Eclampsia; Complicating PregnancyNCT04777097
Blood Loss and Preeclampsia
An observational study of Pre-Eclampsia; Complicating Pregnancy and Blood Loss, run by University of Zurich at 1 site in Switzerland.
Trial summary
Study of blood loss in preeclamptic patients using mathematical formulae Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia; Complicating Pregnancy, Blood Loss, Coagulation Disorder
- What is being tested?
- Blood sample
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 28 Feb 2025
- 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: Patients with pre-eclampsia planed for cesarean section vs. healty pregnant women, planmned for cesarean section
Who may be able to join
- Elective or urgent caesarean section
- Written informed consent
Who cannot join
- Emergency caesarean section
- Familial coagulation disorder
- Hematological disorders that affect the platelet count, e.g. myelodysplastic syndrome (MDS)
- Taking anticoagulants
- Taking aspirin in the last 14 days
- Use of NSARs in the last 24 hours
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Institute for Anesthesiology
Zurich, 8091
Marco P Zalunardo, Prof, +41442552695, marco.zalunardo@usz.ch
Donat R Spahn, Prof, +41442552695, donat.spahn@usz.ch
About this study
Official title: Does Preeclampsia Affect Blood Loss During a Caesarean Procedure
Study of blood loss in preeclamptic patients using mathematical formulae
Read the detailed description
Pre-eclampsia is a symptom complex that occurs in 2-5% of all pregnancies and leads to significant morbidity and mortality. It is associated with a risk of impaired coagulation caused by a reduced platelet count, very rarely by disseminated intravascular coagulation disorders. The degree of clotting correlates with the severity of preeclampsia. It is planned to calculate the blood loss using mathematical formulas and to compare the different blood loss in the two groups (preeclampsia vs. healthy pregnant women). Furthermore, this project will try to correlate the blood loss with the underlying coagulation situation. The aim is to be able to better assess the bleeding risk in healthy pregnant women, but also in pre-eclamptic patients in the future.
- Being tested
- Blood sample
- Keywords
- Pre-eclampsia, blood-loss, impaired coagulation
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications, Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Two blood sample will be drawn. On the day of operation and the first postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnant women | Healthy patients who receive a cesarean operation Receives: Other: Blood sample | |
| Pre-eclampsia | Patients with pre-eclampsia who receive a caesarean operation Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-Loss
Corelation between blood loss and coagulation parameters will be calculated
Measured: day 1
Secondary outcomes (1)
Coagulation parameter
Impact of pre-eclampsia on the coagulation parameters
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Jan 2021
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre-Eclampsia; Complicating PregnancyStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco P Zalunardo, Principal investigator, Institut of Anesthesiology University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777097
- Sponsor's protocol ID
- 2020-00123
- Status last verified
- Dec 2023
- First submitted
- 25 Feb 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x.
PubMed 9354828Theusinger OM, Kind SL, Seifert B, Borgeat L, Gerber C, Spahn DR. Patient blood management in orthopaedic surgery: a four-year follow-up of transfusion requirements and blood loss from 2008 to 2011 at the Balgrist University Hospital in Zurich, Switzerland. Blood Transfus. 2014 Apr;12(2):195-203. doi: 10.2450/2014.0306-13.
PubMed 24931841de Lange NM, Lance MD, de Groot R, Beckers EA, Henskens YM, Scheepers HC. Obstetric hemorrhage and coagulation: an update. Thromboelastography, thromboelastometry, and conventional coagulation tests in the diagnosis and prediction of postpartum hemorrhage. Obstet Gynecol Surv. 2012 Jul;67(7):426-35. doi: 10.1097/OGX.0b013e3182605861.
PubMed 22926249
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preeclampsia Affect Blood Loss During a Caesarean Procedure
- ClinicalTrials.gov ID
- NCT04777097
- Acronym / sponsor ID
- 2020-00123
- Keywords
- Pre-eclampsia, blood-loss, impaired coagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 2 Mar 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.
Study of blood loss in preeclamptic patients using mathematical formulae
Detailed description
Pre-eclampsia is a symptom complex that occurs in 2-5% of all pregnancies and leads to significant morbidity and mortality. It is associated with a risk of impaired coagulation caused by a reduced platelet count, very rarely by disseminated intravascular coagulation disorders. The degree of clotting correlates with the severity of preeclampsia. It is planned to calculate the blood loss using mathematical formulas and to compare the different blood loss in the two groups (preeclampsia vs. healthy pregnant women). Furthermore, this project will try to correlate the blood loss with the underlying coagulation situation. The aim is to be able to better assess the bleeding risk in healthy pregnant women, but also in pre-eclamptic patients in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant women | – | Other: Blood sampleHealthy patients who receive a cesarean operation |
| Pre-eclampsia | – | Other: Blood samplePatients with pre-eclampsia who receive a caesarean operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with pre-eclampsia planed for cesarean section vs. healty pregnant women, planmned for cesarean section
Key inclusion criteria (2 listed)
- Elective or urgent caesarean section
- Written informed consent
Key exclusion criteria (6 listed)
- Emergency caesarean section
- Familial coagulation disorder
- Hematological disorders that affect the platelet count, e.g. myelodysplastic syndrome (MDS)
- Taking anticoagulants
- Taking aspirin in the last 14 days
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 |
|---|---|---|
| Blood sampleTwo blood sample will be drawn. On the day of operation and the first postoperative day. | Other | Pre-eclampsia, healthy pregnant women |
Primary outcome
Blood-Loss
Time frame: day 1
Corelation between blood loss and coagulation parameters will be calculated
1 secondary outcome
Coagulation parameter
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Results publication: PubMed 9354828Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x.
- Results publication: PubMed 24931841Theusinger OM, Kind SL, Seifert B, Borgeat L, Gerber C, Spahn DR. Patient blood management in orthopaedic surgery: a four-year follow-up of transfusion requirements and blood loss from 2008 to 2011 at the Balgrist University Hospital in Zurich, Switzerland. Blood Transfus. 2014 Apr;12(2):195-203. doi: 10.2450/2014.0306-13.
- Results publication: PubMed 22926249de Lange NM, Lance MD, de Groot R, Beckers EA, Henskens YM, Scheepers HC. Obstetric hemorrhage and coagulation: an update. Thromboelastography, thromboelastometry, and conventional coagulation tests in the diagnosis and prediction of postpartum hemorrhage. Obstet Gynecol Surv. 2012 Jul;67(7):426-35. doi: 10.1097/OGX.0b013e3182605861.
- Individual participant dataSharing planned: Undecided
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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.
Marco P Zalunardo principal investigator
Institut of Anesthesiology University Hospital Zurich
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 Pre-Eclampsia; Complicating Pregnancy and Blood Loss, run by University of Zurich at 1 site in Switzerland.
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 6 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 5 Dec 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 Switzerland. 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?
Contact Marco P Zalunardo, Prof (+41442552695, marco.zalunardo@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-Loss (time frame: day 1). 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 NCT04777097, which also lists 3 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 5 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.