Placental growth factor and haeme indicesto predict gestational diabetes mellitus

Completed

Conditions: Gestational diabetes mellitus,

Registration Number: CTRI/2021/05/033724

Lead Sponsor: Dr Mounika Koduri

Brief Summary: Gestational diabetes mellitus (GDM) is one of the leading causes for maternal morbidity. It is a

major public health problem in India with a high prevalence rate of 4.6% to 14%. GDM typically

diagnosed from 24 weeks of gestation. Early diagnosis and prediction are vital, as it can improve

the antenatal care and thus prevents the adverse perinatal outcomes like macrosomia,

shoulder dystocia, stillbirths by lifestyle interventions commenced in early pregnancy (<=20

weeks). Placental growth factor (PlGF) which is a placenta-derived angiogenic protein, is

involved in the regulation of placental vascular development. Studies show that there is an

increase in placenta derived growth factor (PlGF) in Gestational diabetes mellitus (GDM) due to

a compensatory angiogenic mechanism in response to hyperglycemia induced placental

hypoxia. So, in our study we are investigating whether Placental growth factor (PlGF) value in

first trimester predicts the occurrence of Gestational diabetes mellitus (GDM). Low-grade

chronic inflammation is associated with various obstetric complications such as preterm birth,

preeclampsia, and gestational diabetes mellitus. Platelets indices such as Mean platelet volume

(MPV), plateletcrit (PCT), platelet distribution width (PDW) plays important role in blood

coagulation and inflammatory process. Also, CBC parameters such as neutrophil lymphocyte

ratio (NLR) have been studied to predict Gestational diabetes mellitus (GDM), hence we are

trying to create a prediction model for GDM using these parameters.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 320

Inclusion Criteria

Inclusion Criteria: Singleton pregnancies at 11-14 weeks of gestation, at the time of combined screening for aneuploidy and preeclampsia by ultrasound scan and maternal serum biochemistry, who come to obstetrics and gynaecology OPD of Kasturba Hospital Manipal for regular ANC checkup.

Exclusion Criteria

Exclusion Criteria: 1)Women who have been diagnosed with hypertensive disorders in pregnancy 2)Previous pregnancy complicated with Gestational diabetes mellitus (GDM) 3)Pre-existing diabetes mellitus detected by HbA1C >6 4)Pregnancies with chromosomal abnormal fetuses or structural defects at 11-14 weeks 5)Pregnancies diagnosed with severe Early onset IUGR 6)Those who are not willing to participate in the study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Diagnosis of GDM and its correlation with PlGF and blood parameter values at 11-14 weeks	1) Diagnosis of GDM and its correlation with PlGF and blood parameter values at 11 a 14 weeks \| 2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams), \| Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge \| to PIGF values.
2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams),	1) Diagnosis of GDM and its correlation with PlGF and blood parameter values at 11 a 14 weeks \| 2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams), \| Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge \| to PIGF values.
to PIGF values.	1) Diagnosis of GDM and its correlation with PlGF and blood parameter values at 11 a 14 weeks \| 2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams), \| Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge \| to PIGF values.
Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge	1) Diagnosis of GDM and its correlation with PlGF and blood parameter values at 11 a 14 weeks \| 2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams), \| Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge \| to PIGF values.

Secondary Outcome Measures

Name	Time	Method
2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams) at 36-40 weeks	Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge

Trial Locations

Locations (1): KMC MANIPAL
🇮🇳
Udupi, KARNATAKA, India
KMC MANIPAL
🇮🇳Udupi, KARNATAKA, India
MOUNIKA KODURI
Principal investigator
7087806268
mounikakoduri@gmail.com