Effect of various parameters of complete blood count in patients with preeclampsia

Not yet recruiting

Conditions: Unspecified pre-eclampsia,

Registration Number: CTRI/2020/09/027531

Lead Sponsor: AIIMS New Delhi

Brief Summary: Hyperactivation of inflammatory and immunologic responses in pre-eclampsia causes a marked increase in neutrophil count and modulation of neutrophil function toward greater production of superoxide compared with nitric oxide, which results in endothelial damage and dysfunction. Pre-eclampsia is also known to cause platelet activation, manifesting as low platelet count and high mean platelet volume (MPV).

Systemic immune inflammation indices derived from peripheral blood cells have recently attracted much attention because they are easily measurable and available. Abnormal changes in white blood cells counts have been observed in Preeclampsia, although the role of these systemic inflammatory indicators in clinical assessment, differential diagnosis and prognosis evaluation of PE remains unclear.

Hence this prospective comparative observational studyis being planned to assess the level of leucocyte and platelet indices in preeclampsia in Asian Indian women and comparison with normotensive pregnant women and to study the correlation of these indices with severity of preeclampsia as well as correlation among various parameters as none of the previous prospective study has evaluated correlation between these indices.

The study group will comprise of 40 pregnant women aged 18â€“40 years who are diagnosed with pre-eclampsia (blood pressure elevation â‰¥140/90 mm Hg on two occasions 4 hours apart with proteinuria or any of the severe features of pre-eclampsia: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, cerebral or visual disturbances). 80 gestational age-matched, healthy pregnant women will be enrolled into the control group. In this study, ratio of cases : controls will be maintained as 1:2; so as to get adequate representation among the controls and also to compensate for controls who will be likely to develop preeclampsia in the late stage of pregnancy, as such cases will be excluded from analysis. So sample size for cases and control will be 40 and 80 respectively.

Primary objectives of this study will be to assess the level of leucocyte and platelet indices (NLR, MLR, PLR, PDW, MPV) in preeclampsia in Asian Indian women and comparison with normotensive pregnant women and to correlate these indices with severity of preeclampsia

Secondary objectives will be to find the correlation among NLR, MLR, PLR, PDW, MPV; to correlate these markers with adverse feto-maternal and neonatal outcome; to evaluate other haematological markers such as RDW, Plateletcrit, absolute values of platelet count in preeclampsia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 40

Inclusion Criteria

Patients of preeclampsia meeting following criteria Systolic blood pressure>140 and/or DBP>90 mm of Hg on two occasions at least 4 hours apart; and proteinuria of >1+ on dipstick or 300 mg/day, after 20 week of gestation.

Exclusion Criteria

Chronic hypertension Overt diabetes/GDM type A2 Renal Disease Fever within previous 1 week of diagnosis Collagen vascular disorder Rheumatoid arthritis Known autoimmune disorders.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Values of NLR,MLR,PLR,MPV,PDW in patient of preeclampsia	At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery
NLR: Neutrophil to lymphocyte ratio	At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery
- Correlation of these markers with severity of preeclampsia	At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery
MLR: Monocyte to lymphocyte ratio	At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery
PLR: Platelet to lymphocyte ratio	At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery
MPV: Mean platelet volume	At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery
PDW: Platelet distribution width	At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

Secondary Outcome Measures

Name	Time	Method
1.Maternal outcome: Eclampsia, HELLP syndrome, Mode of delivery	2.Fetal outcome: fetal growth restriction,intrauterine fetal death,prematurity and low birth weight

Trial Locations

Locations (1): All india Institute of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
All india Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Vidushi Kulshrestha
Principal investigator
9891910880
drvidushi.kul@gmail.com