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Clinical Trials/CTRI/2024/04/065086
CTRI/2024/04/065086Not yet recruitingNot Applicable

STUDY OF HIGH SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) LEVELS IN EARLY AND LATE ONSET PRE ECLAMPSIA IN A TERTIARY CARE HOSPITAL - ONE YEAR CROSS SECTIONAL STUDY

Chintakindi Preethi1 site in 1 country96 target enrollmentStarted: April 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
96
Locations
1
Primary Endpoint
To study high sensitive c reactive protein levels in early onset pre ecclampsia and late onset pre ecclampsia in pregnancy

Study Overview

Brief Summary

Need for the study

There are no studies regarding hs CRP levels in early onset and late onset preeclampsia. This study aims to assess the significance of hs CRP levels in early and late onset preeclampsia and its clinical significance in maternal and fetaloutcome. If proved significant hs CRP can be used as a prognostic indicator in severe pre eclampsia in low resource settings as it is more economical compared to other placental biomarkers like PlGF and Sflt1in preeclampsia.

Study Protocol

All antenatal women diagnosed with pre eclampsia beyond 20 weeks of period of gestation admitted in antenatal ward or labour room at KLE Dr Prabhakar kore hospital and medical research centre associated to KAHER’s Jawaharlal Nehru Medical College, Belagavi will be recruited in this study.

They will be asked to sign the informed consent and enrolled for the study

The patients who satisfy the inclusion criteria and do not fall under exclusion criteria are recruited in the study.

Venous blood sample will be taken from antenatal women diagnosed with preeclampsia beyond 20 weeks of gestation and  sent for investigation along with other biochemical parameters.

The sample will be centrifuged and hsCRP level will be measured by immunoturbidimetry method.

The final diagnosis will be made after noting the investigations and the patient will be categorized into early onset preeclampsia and late onset preeclampsia according to their definitions

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •All preeclamptic pregnant women who are admitted in antenatal ward or labour room
  • •Singleton pregnancy
  • •Pre eclamptic women willing to participate in the study.

Exclusion Criteria

  • •Preeclamptic women with history of fever or recent infections or who are receiving antibiotic treatment or steroids.
  • •Preeclamptic women in labour or presenting with PROM or clinical chorioamnionitis.
  • •Preeclamptic women with chronic inflammatory disorders like arthritis, inflammatory bowel disorders, SLE etc.
  • •Preeclamptic women with medical disorders (Diabetes mellitus, hepatic disorders, renal disorders)
  • •Pregnant women whose BMI > 25kg/m2.

Outcomes

Primary Outcomes

To study high sensitive c reactive protein levels in early onset pre ecclampsia and late onset pre ecclampsia in pregnancy

Time Frame: 20 weeks - 40 weeks

Secondary Outcomes

  • Fetomaternal outcome in raised hsCRP Levels(1 month)

Investigators

Sponsor
Chintakindi Preethi
Sponsor Class
Other [self]

Study Sites (1)

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