Prediction of materno-fetal outcome in gestational diabetes mellitus using SFLT1/PLGF Ratio in third trimester.

AIM: To study the predictive value of soluble fms like tyrosine kinase and placental growth factor ratio for materno-fetal outcome in women with gestational diabetes mellitus(GDM).

OBJECTIVES:

1. To determine soluble fms like tyrosine kinase1 and placental growth factor ratio and materno-fetal outcome in gestational diabetes mellitus and to assess the predictive value of soluble fms like tyrosine kinase1 and placental growth factor ratio for adverse materno-fetal outcome in gestational diabetes mellitus.

VENUE OF STUDY: The present study will be conducted in the Department of Obstetrics and Gynaecology and Department of pathology VMMC & Safdarjung Hospital, New Delhi.

STUDY DESIGN: Prospective cohort Observational Study.

DURATION OF STUDY: 18 months.

STUDY SETTING: Department of Obstetrics and Gynaecology and department of pathology VMMC & Safdarjung Hospital, New Delhi.

STUDY POPULATION: All antenatal women fulfilling the eligibility criteria during the study period.

ELIGIBILITY CRITERIA

INCLUSION CRITERIA-

• Antenatal women with singleton pregnancy and GDM at age of ≥18 years and Period of gestation >28 weeks.

EXCLUSION CRITERIA

• Pre-pregnancy diabetes (type 1 and type 2).

• Congenital malformation in fetus.

• Antenatal women with intra-uterine fetal death (IUFD).

• Pre-existing medical comorbidity –chronic hypertension, Overt DM, Chronic Kidney Disease,Heart disease etc.

METHODOLOGY

This study titled “Prediction of materno-fetal outcome in gestational diabetes mellitus using sflt1/plgf ratio in third trimeseter.” is a prospective cohort study that will be performed with 200 participants over 18 months duration in the Department of Obstetrics and Gynaecology, VMMC and SJH, New Delhi. All antenatal women admitted for delivery will be screened for eligibility as per inclusion and exclusion criteria of the study. All eligible women will be enrolled in the study after informed consent.

Participants’ baseline characteristics, including age, gestational age, BMI, gravidity, parity, medical history, obstetrical history, and family history of diabetes will be recorded using a pre-designed proforma.

A single venous blood sample (2 mL) will be collected from each participant after enrolment for estimation of SFLT 1 and PLGF levels. Samples will be collected in a plain tube and transported to the laboratory in ice-cold condition with biohazard symbol on the transportation box. The SFLT 1 and PLGF ratio will be calculated from the obtained values. 2ml of blood collected in plain vial will be centrifuged to separate the serum sample. SFLT 1 and PLGF will be performed on COBAS e411analyser which is based on the Chemiluminescence assay.

Participants will be followed up until delivery to assess perinatal outcomes. Maternal and fetal parameters will be recorded as follows.

Maternal parameter will include the period of gestation (POG) at delivery, mode of delivery, development of any obstetrics comorbidity,maternal HDU/ICU admission and maternal moratlity.

Fetal parameters will include birth weight,Apgar score at 5 minutes,NICU admission and Neonatal mortality.

The data will be tabulated in an excel spreadsheet and statistical analysis will be done using SPSS2021 (IBM Corp.)

OUTCOME MEASURES

1.) SFLT 1 and PLGF ratio.

2.) Materno-fetal outcome in women with gestationl diabetes mellitus.