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
1 other identifier
observational
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2018
CompletedStudy Start
First participant enrolled
September 8, 2018
CompletedFirst Posted
Study publicly available on registry
September 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedSeptember 13, 2019
September 1, 2019
10 months
September 4, 2018
September 12, 2019
Conditions
Outcome Measures
Primary Outcomes (7)
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
Study Arms (2)
Parturients physiologic pregnancy
Parturients undergoing caesarean delivery with physiologic pregnancy
Parturients with risk pregnancy
Parturients undergoing caesarean with risk of complications (pre-eclampsia, HELLP syndrom, placenta praevia, placental abruption, IUGR, previous post partum hypotony).
Interventions
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).
Eligibility Criteria
Parturients indicated for caesarean section
You may qualify if:
- Pregnant women undergoing the Caesarean delivery
- Signed informed consent
You may not qualify if:
- Previous hepatitis or other hepatocyte damage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Brno
Brno, 62500, Czechia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
September 4, 2018
First Posted
September 11, 2018
Study Start
September 8, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
September 13, 2019
Record last verified: 2019-09