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Serum Immunologic Markers Levels in During the Delivery (DIMDOED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664999
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Study Description
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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.

Study Design
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Study Type : Observational
Actual Enrollment : 57 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
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019
Groups and Cohorts
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Czechia
University Hospital Brno
Brno, Czechia, 62500
Sponsors and Collaborators
Brno University Hospital
More Information
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Responsible Party: Petr Štourač, MD, Clinical Professor, Brno University Hospital
ClinicalTrials.gov Identifier: NCT03664999    
Other Study ID Numbers: KDAR FN Brno 2018/9
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
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