Serum Immunologic Markers Levels in During the Delivery (DIMDOED)

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

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.

Study Overview

• Status: Completed
• Conditions: Immunologic Markers
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • University Hospital Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Parturients indicated for caesarean section

Description

Inclusion Criteria:

• Pregnant women undergoing the Caesarean delivery
• Signed informed consent

Exclusion Criteria:

• Previous hepatitis or other hepatocyte damage

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: Blood sample

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KDAR FN Brno 2018/9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No