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Completed

NCT Number: NCT03664999

Serum Immunologic Markers Levels in During the Delivery

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.

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Key information

Conditions

Immunologic Markers

Age range

15 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Brno

Brno, 62500, Czechia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women undergoing the Caesarean delivery
  • Signed informed consent

Exclusion criteria

  • Previous hepatitis or other hepatocyte damage

Treatment and study plan

Blood sampling

Diagnostic Test

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 names: Blood sample

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

Dynamics of Serum Immunologic Markers Levels in During the Delivery and Possible Benefit for Obstetric Emergency Diagnostics

Acronym: DIMDOED

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2018
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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