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RecruitingNCT04777097Updated Dec 5, 2023

Blood Loss and Preeclampsia

An observational study in Pre-Eclampsia; Complicating Pregnancy, Blood Loss and Coagulation Disorder, sponsored by University of Zurich. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by University of Zurich · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2021; still recruiting 5 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pre-Eclampsia; Complicating Pregnancy
  • Blood Loss
  • Coagulation Disorder

Keywords

  • Pre-eclampsia
  • blood-loss
  • impaired coagulation
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 120 is below the median of 165 across 397 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,050 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Probability sample

Study population

Patients with pre-eclampsia planed for cesarean section vs. healty pregnant women, planmned for cesarean section

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elective or urgent caesarean section
  • Written

Exclusion criteria

Exclusion Criteria:

  • Emergency caesarean section
  • Familial coagulation disorder
  • Hematological disorders that affect the count, e.g. myelodysplastic syndrome (MDS)
  • Taking anticoagulants
  • Taking aspirin in the last 14 days
  • Use of NSARs in the last 24 hours
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • healthy pregnant women

    Healthy patients who receive a cesarean operation

    Other: Blood sample

  • Pre-eclampsia

    Patients with pre-eclampsia who receive a caesarean operation

    Other: Blood sample

Interventions

  • OtherBlood sample

    Two blood sample will be drawn. On the day of operation and the first postoperative day.

06

What researchers measure

Primary outcomes

  1. Blood-Loss

    Corelation between blood loss and coagulation parameters will be calculated

    Time frame: day 1

Secondary outcomes

  1. Coagulation parameter

    Impact of pre-eclampsia on the coagulation parameters

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
  • University Hospital Zurich, Institute for Anesthesiology
    Zurich, 8091, Switzerland
    Recruiting
08

References and documents

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 9354828 ↗
  • Theusinger 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 24931841 ↗
  • de 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Feb 2025, 49 months after the start.

Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 49 months is above that.

Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2021
First posted
Mar 2, 2021
StartActual
Jan 1, 2021
Primary completionEst.
Feb 28, 2025
CompletionEst.
Feb 28, 2025
Last update
Dec 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04777097
Responsible party
Sponsor
First posted
Mar 2, 2021
Start date
Jan 1, 2021
Primary completion
Feb 28, 2025 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Dec 5, 2023

Study contacts

Marco P Zalunardo, Prof
Contact
marco.zalunardo@usz.ch
+41442552695
Donat R Spahn, Prof
Contact
donat.spahn@usz.ch
+41442552695
Marco P Zalunardo
principal investigator · Institut of Anesthesiology University Hospital Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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