Serum Immunologic Markers Levels in During the Delivery

Completed

• Conditions: Immunologic Markers
• Interventions: Diagnostic Test: Blood sampling

• Registration Number: NCT03664999
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-07
• Study Start: 2018-09-08
• Study First Posted: 2018-09-11
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• Pregnant women undergoing the Caesarean delivery
• Signed informed consent

Exclusion Criteria

• Previous hepatitis or other hepatocyte damage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parturients with risk pregnancy	Blood sampling	Parturients undergoing caesarean with risk of complications (pre-eclampsia, HELLP syndrom, placenta praevia, placental abruption, IUGR, previous post partum hypotony).
Parturients physiologic pregnancy	Blood sampling	Parturients undergoing caesarean delivery with physiologic pregnancy

Primary Outcome Measures

Name	Time	Method
Change in levels of total C1 inhibitor	30 minutes before and 30 minutes after delivery	Chenge in levels of total C1 inhibitor
Change in levels of D vitamin levels	30 minutes before and 30 minutes after delivery	Change in levels of D vitamin levels and it's relationship to pre-eclampsia
Change in levels of ACE levels	30 minutes before and 30 minutes after delivery	Change in levels of ACE levels
Change of C1 inhibitor activity	30 minutes before and 30 minutes after delivery	Change of C1 inhibitor activity
Change in levels of CRP levels	30 minutes before and 30 minutes after delivery	Change in levels of CRP levels
Change in levels of total C3	30 minutes before and 30 minutes after delivery	Change in levels of total C3
Change in levels of total C4	30 minutes before and 30 minutes after delivery	Change in levels of total C4

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, Czechia