Trial document





This trial has been registered retrospectively.
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  DRKS00005624

Trial Description

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Title

Peripartal Coagulation -Impact of prepartum concentration of fibrinogen on the clot formation and the thromboelastometry derived parameters (ROTEM®) with regard to the partal blood loss

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Trial Acronym

PepCo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this pilot trial pregnant women were prospectively enrolled at admission to labor ward for delivery.. Various parameters of blood coagulation in clinical routine, such as fibrinogen, were measured before birth, max. 1 h and 48 h after birth and were related to the measured partal blood loss. In addition viscoelastic coagulation parameters using thromboelastometry were measured at the mentioned time points.
The aim of the study was to investigate the predictive value of prepartum parameters of coagulation and thromboelastometry for blood loss during labor.
This pilot study is a part of the study " Determination of fibrinogen concentration in the blood plasma to estimate the risk of bleeding during labor" Department of Obstetrics, (Klinik für Geburtsmedizin der Charité Universitätsmedizin Berlin, EA2118-11, Ethik-Kommission der Charité -Universitätsmedizin Berlin)

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Brief Summary in Scientific Language

Background and Goal of Study: After vaginal delivery postpartum hemorrhage (PPH) is defined as blood loss greater than 500 ml (1). Decreased fibrinogen levels (Fbg) were reported to be associated with PPH (2), but the predictive validity of prepartum Fbg and viscoelastic parameters of coagulation for the occurrence of PPH is still unknown. Therefore, the aim of this study is to investigate the values of pre and postpartum concentrations of Fbg, and the parameters of thromboelastometry and their predictive capability in respect of partal blood loss during vaginal delivery.
The main hypotheses are:
- in women with a partum blood loss> 500ml during vaginal delivery, a prepartum reduction of the maximum clot firmness (MCF)> 5 mm in the FIBTEM® test ( ROTEM® analysis) is detectable
- Significant changes of viscoelastic parameters in the prepartum ROTEM® analysis are dependent on a prepartum fibrinogen level <4 g / l.

Material and Methods: Singleton pregnant women are prospectively enrolled at admission to the delivery ward. Fbg (measured according to Clauss) and parameters of ROTEM® (thromboelastometry, TEM® Munich, Germany) are measured prepartum at admission to the delivery ward (generally < 24 h before delivery). A second blood sample are drawn within 1 hour after delivery and another after 48h. Intrapartum blood loss are measured systematically by a calibrated drape under buttocks until active bleeding ceased.

Literatur: (1) WHO recommendations for the prevention and treatment of postpartum haemorrhage, Dept. of Reproductive Health and Research, WHO (2012)
(2) Charbit B. et al.,The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost 2007; 5: 266–73.

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Organizational Data

  •   DRKS00005624
  •   2014/02/13
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  •   yes
  •   Approved
  •   EA2/118/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   peripartal coagulation,
    post partum haemorrhage (PPH)
  •   PPH in combination with fibrinogen concentration, parameters of plasmatic coagulation and partal blood loss
  •   O72 -  Postpartum haemorrhage
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Interventions/Observational Groups

  •   - women with vaginal delivery and a partal blood loss < 500 ml ;
    - Fibrinogen levels (measured according to Clauss) and parameters of ROTEM® (thromboelastometry, TEM® Munich, Germany) are measured prepartum at admission to the delivery ward (generally < 24 h before delivery). A second blood sample are drawn within 1 hour after delivery and another after 48h. Intrapartum blood loss are measured systematically by a calibrated drape under buttocks.

  •   - women with vaginal delivery and a partal blood loss > 500 ml;
    - Fibrinogen levels (measured according to Clauss) and parameters of ROTEM® (thromboelastometry, TEM® Munich, Germany) are measured prepartum at admission to the delivery ward (generally < 24 h before delivery). A second blood sample are drawn within 1 hour after delivery and another after 48h. Intrapartum blood loss are measured systematically by a calibrated drape under buttocks.

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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1. Prepartal determination of Maximum Clotting Formation (MCF) in the Fibtem® test (ROTEM® ,TEM, München) and fibrinogen concentration (measured according to Clauss)

2. Intrapartum measurement of blood loss systematically by a calibrated drape under buttocks (Brenner Medical, München)

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Secondary Outcome

1. Determination of MCF in the Fibtem® test (ROTEM® analysis) and fibrinogen concentration after delivery and 48 h postpartum
2. Determination of Clotting Time (CT) and Clotting Formation Time (CFT) in the INTEM® test (ROTEM® analysis) pre- and postpartal (after delivery and 48h postpartum)
3. Different viscoelastic parameters ( CT, CFT, alpha angle ) of ROTEM® analysis (INTEM®, EXTEM®, APTEM®)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/09/03
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- pregnant women at admission to the labor ward for vaginal delivery
- minimum age 18 years
- consent of women for use of personal data

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Exclusion Criteria

- not able to speak and understand german
- doubt of ability to judge

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Addresses

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    • Charitè Universitätsmedizin Berlin Klinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Prof. Dr.  Christian  von Heymann 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charitè Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr.  Lutz  Kaufner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charitè Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr.  Lutz  Kaufner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charitè Universitätsmedizin Berlin Klinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Prof. Dr.  Christian  von Heymann 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.