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Serum Immunologic Markers Levels in During the Delivery (DIMDOED)

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ClinicalTrials.gov Identifier: NCT03664999
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Brief Summary:
This study aim to describe dynamics of immunologic markers C1 inhibitor, C3, C4 during the delivery in order to improve early diagnostics of obstetric emergencies, especially with immune etiology.

Condition or disease Intervention/treatment
Immunologic Markers Diagnostic Test: Blood sampling

Detailed Description:

Our prospective observational study will explore the differences between dynamics of the complement components C1 inhibitor, C1 inhibitor activity, C3, C4 during the labour in a group of women with physiologic pregnancy and in a group with a risk of complications (pre-eclampsia, HELLP syndrome, placenta praevia, placental abruption, IUGR, previous post partum hypotony).

We will focus on women undergoing the Caesarean delivery. We will also measure D vitamin levels and ACE levels and search for some contexts.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamics of Serum Immunologic Markers Levels in During the Delivery and Possible Benefit for Obstetric Emergency Diagnostics
Actual Study Start Date : September 8, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
Parturients physiologic pregnancy
Parturients undergoing caesarean delivery with physiologic pregnancy
Diagnostic Test: Blood sampling
differences between dynamics of the complement components C1 inhibitor, C1 inhibitor activity, C3, C4 during the labour in a group of women with physiologic pregnancy and in a group with a risk of complications (pre-eclampsia, HELLP syndrome, placenta praevia, placental abruption, IUGR, previous post partum hypotony).
Other Name: Blood sample

Parturients with risk pregnancy
Parturients undergoing caesarean with risk of complications (pre-eclampsia, HELLP syndrom, placenta praevia, placental abruption, IUGR, previous post partum hypotony).
Diagnostic Test: Blood sampling
differences between dynamics of the complement components C1 inhibitor, C1 inhibitor activity, C3, C4 during the labour in a group of women with physiologic pregnancy and in a group with a risk of complications (pre-eclampsia, HELLP syndrome, placenta praevia, placental abruption, IUGR, previous post partum hypotony).
Other Name: Blood sample




Primary Outcome Measures :
  1. Change in levels of total C1 inhibitor [ Time Frame: 30 minutes before and 30 minutes after delivery ]
    Chenge in levels of total C1 inhibitor

  2. Change in levels of CRP levels [ Time Frame: 30 minutes before and 30 minutes after delivery ]
    Change in levels of CRP levels

  3. Change in levels of D vitamin levels [ Time Frame: 30 minutes before and 30 minutes after delivery ]
    Change in levels of D vitamin levels and it's relationship to pre-eclampsia

  4. Change in levels of ACE levels [ Time Frame: 30 minutes before and 30 minutes after delivery ]
    Change in levels of ACE levels

  5. Change of C1 inhibitor activity [ Time Frame: 30 minutes before and 30 minutes after delivery ]
    Change of C1 inhibitor activity

  6. Change in levels of total C3 [ Time Frame: 30 minutes before and 30 minutes after delivery ]
    Change in levels of total C3

  7. Change in levels of total C4 [ Time Frame: 30 minutes before and 30 minutes after delivery ]
    Change in levels of total C4



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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Parturients indicated for caesarean section
Criteria

Inclusion Criteria:

  • Pregnant women undergoing the Caesarean delivery
  • Signed informed consent

Exclusion Criteria:

  • Previous hepatitis or other hepatocyte damage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664999


Contacts
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Contact: Klára Peškova, MD 53223 8413 ext 00420 peskova.klara@fnbrno.cz
Contact: Petr Štourač, doc.MD.Ph.D 532234404 ext 00420 Stourac.Petr@fnbrno.cz

Locations
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Czechia
University Hospital Brno Recruiting
Brno, Czechia, 62500
Contact: Klára Pešková, MD    53223 8413 ext 00420    peskova.klara@fnbrno.cz   
Contact: Petr Štourač, MD    532234404 ext 00420    Stourac.Petr@fnbrno.cz   
Sponsors and Collaborators
Brno University Hospital

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Responsible Party: Petr Štourač, MD, Clinical Professor, Brno University Hospital
ClinicalTrials.gov Identifier: NCT03664999     History of Changes
Other Study ID Numbers: KDAR FN Brno 2018/9
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No