| 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
|
|
|
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
|
|
|
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. |