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CTRI Number  CTRI/2024/04/066044 [Registered on: 22/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Prediction of hypertensive disorder of pregnancy in first trimester using blood pressure,ultrasonography and pregnancy associated blood marker.  
Scientific Title of Study   Prospective observational study for prediction of pre-eclampsia at 11 to 14 weeks of gestation using mean arterial pressure, uterine artery doppler and pregnancy-associated plasma protien-A.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gargee Sharma 
Designation  Dnb Obgy Resident, Bhaktivedanta Hospital  
Affiliation  BhaktiVedanta Hospital and Research Institute 
Address  Fourth floor, Maternity ward, srishti complex, bhaktivedanta swami marg, Mira road east, Thane.

Thane
MAHARASHTRA
401107
India 
Phone  8770570662  
Fax    
Email  sharmadgargee@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kamalapriya Thiyagarajan 
Designation  Consultant Gynaecologist 
Affiliation  BhaktiVedanta Hospital and Research Institute 
Address  OPD no. 2, Ground floor, Srishti complex, Bhaktivedanta Swami Marg, Mira road east, Thane. 401107, India

Thane
MAHARASHTRA
401107
India 
Phone  8879614447  
Fax    
Email  drkamalapriyat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gargee Sharma 
Designation  Dnb Obgy Resident, Bhaktivedanta Hospital  
Affiliation  BhaktiVedanta Hospital and Research Institute 
Address  Fourth floor, Maternity ward, srishti complex, bhaktivedanta swami marg, Mira road east, Thane.

Thane
MAHARASHTRA
401107
India 
Phone  8770570662  
Fax    
Email  sharmadgargee@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute, Srishti Complex, Bhaktivedanta Swami Mard, Mira Road (East), Thane-401107 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Srishti Complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane-401107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gargee Sharma  Bhaktivedanta Hospital and Research Institute  Srishti complex, Bhaktivedanta swami marg, Mira road east, Thane. 401107, India
Thane
MAHARASHTRA 
08770570662

sharmadgargee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BhaktiVedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Pregnant females of age 18 to 45 years who are registered and planning to deliver at bhakti Vedanta hospital and willing for regular antenatal visits.
2. Willing to participate in study.
 
 
ExclusionCriteria 
Details  Patients with fetal chromosomal abnormality.
Patients diagnosed with multifetal pregnancy.
Patients having chronic hypertension or diagnosed with pre-eclampsia in previous pregnancy.
Patients having renal disease
obesity (BMI more than 40)
Autoimmune disorder like SLE
Not willing to participate in study
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increased chances of development of pre-eclampsia are seen with PAPP-A values less than 0.5 MOM at 11 to 14 weeks,High mean arterial pressure increases the risk of pre-eclampsia, Abnormal uterine artery pulsatility index values have higher risk for development of pre-eclampsia.
 
at 11 to 14 weeks, at 20 to 34 weeks, at the time of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of severity of pre-eclampsia using PAPP-A, mean arterial pressure and uterine artery pulsatility index values,Association of the time of development of pre-eclampsia i.e., early or late onset with PAPP-A values, mean arterial pressure and uterine artery pulsatility index,Correlation of fetal growth restriction with low PAPP-A values and high uterine artery pulsatility index,Evaluation of neonatal complications such as apgar score, birth weight and requirement of nicu admission in patients of pre-eclampsia
 
at 11 to 14 weeks, at 20 to 34 weeks, at the time of delivery 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Primary objective of this study is prediction of development of pre-eclampsia (early or late onset) at 11 to 14 weeks of gestation using mean arterial pressure, uterine artery pulsatility index and PAPP-A

Secondary objective of this study is prediction of severity of pre-eclampsia, early or late onset pre-eclampsia, fetal growth restriction, neonatal complications.

The study is a single center prospective observational study. The study will be conducted in the outpatient and inpatient departments of obstetrics and gynecology in Bhaktivedanta hospital, Mira Road east, Thane. The study duration is 2 Year. The study will be conducted among pregnant females who visited the outpatient department (OPD) or admitted to the inpatient department (IPD) of obstetrics and gynecology department in Bhakti Vedanta hospital, Mira Road east, Thane. The study participants will be recruited based on the inclusion criteria. First 96 pregnant women will be recruited as per the inclusion criteria at 11 to 14 weeks of gestation. A Detailed informed consent will be taken. Data will be collected from the history taking, general examination findings, routine investigations and current case records of pregnant women who are getting registered. Details will be obtained starting from the Antenatal visit at 11 to 14 weeks till the patient is delivered in our institute.

Mean arterial pressure >106 mmhg will be considered a predictive factor for pre-eclampsia and other complications like FGR.

Serum PAPP-A values <0.5 MOM will be considered as a predictor for development of pre-eclampsia

Uterine artery pulsatility index >95th centile for that gestational age will be used to predict pre-eclampsia in recruited subjects.Data analysis will be done using the SPSS (Statistical package for the social science) version 23 for window. A probability value of 0.05 was accepted as the level of statistical significance. Sample size for this study is 96 cases.

The primary outcome for this study is increased chances of development of pre-eclampsia are seen with PAPP-A values < 0.5 MOM at 11 to 14 weeks, high mean arterial pressure increases the risk of pre-eclampsia, abnormal uterine artery pulsatility index values have higher risk for development of pre-eclampsia.

The secondary outcome for this study is assessment of severity of pre-eclampsia, association of the time of development of pre-eclampsia, correlation of fetal growth restriction with low PAPP-A values and high uterine artery pulsatility index, evaluation of neonatal complications such as apgar score, birth weight and requirement of nicu admission in patients of pre-eclampsia.

The inclusion criteria includes Pregnant females of age 18 to 45 years who are registered and planning to deliver at bhakti Vedanta hospital and willing for regular antenatal visits and willing to participate in study.

The exclusion criteria includes patients with fetal chromosomal abnormality, patients diagnosed with multifetal pregnancy, patients having chronic hypertension or diagnosed with pre-eclampsia in previous pregnancy, patients having renal disease, obesity (BMI>30),  autoimmune disorder like SLE, not willing to participate in study.


 
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