| CTRI Number |
CTRI/2022/06/042956 [Registered on: 01/06/2022] Trial Registered Prospectively |
| Last Modified On: |
31/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ambulatory blood pressure monitoring vs home based blood pressure monitoring in high risk pregnant females |
|
Scientific Title of Study
|
Role of ambulatory blood pressure monitoring in diagnosis of hypertensive disorders during pregnancy in high risk antenatal females : a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Kathuria |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of obstetrics and gynecology Room no 240 OPD Block 2c AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7014982778 |
| Fax |
|
| Email |
dr.priyankathuria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Kathuria |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of obstetrics and gynecology Room no 240 OPD Block 2c AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7014982778 |
| Fax |
|
| Email |
dr.priyankathuria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Kathuria |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of obstetrics and gynecology Room no 240 OPD Block 2c AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7014982778 |
| Fax |
|
| Email |
dr.priyankathuria@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 RAJIV KUMAR |
AIIMS jodhpur |
Department of obs and gyne , OPD Block 2c Room no 240 ,AIIMS Jodhpur
Basni industrial area MIA 2nd phase Basni jodhpur, rajasthan
Jodhpur
RAJASTHAN |
8005634133
rajivmeel097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
antenatal females with High risk for hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ambulatory Blood pressure monitoring |
Ambulatory blood pressure monitor is applied to non-dominant arm of the patient for 24 Hours while patient performs their usual activities. Measurements will be scheduled at every 30 min during wakefulness and every 60 min during sleep |
| Comparator Agent |
Home Based Blood pressure monitoring |
Home based Blood pressure monitoring in High risk antenatal females |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal females at their first visit in OPD, will be screened for the risk of developing HDP in the present pregnancy. They will be categorized into high risk or low risk for HDP on the basis of presence of one of the following criteria:
Presence of any one of the following severe factors:
1. Hypertensive disease during a previous pregnancy
2. Chronic kidney disease
3. Autoimmune disease such as systemic lupus erythematosus or antiphospholipid syndrome
4. Type 1 or type 2 diabetes
OR
Presence of more than 1 of the following moderate factors:
1. first pregnancy
2. age 35 years or older
3. pregnancy interval of more than 10 years
4. body mass index (BMI) of 30 kg/m2 or more (pre-pregnancy weight or weight at first visit)
5. family history of pre-eclampsia
6. multi-fetal pregnancy
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. High risk antenatal females with office BP > or equal to 150/100 mmHg at first antenatal visit
2. Chronic hypertension
3. Already diagnosed HDP
4. Antenatal females not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the overall incidence of Hypertensive disorders of pregnancy in high risk antenatal females diagnosed with ABPM v/s those diagnosed with HBPM. |
18 months for recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare mean number of weeks of developing hypertensive disorder of pregnancy after enrollment in study |
18 months |
| To compare the adverse perinatal outcome in HDP diagnosed females in both the groups. |
18 months for recruitment |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/06/2022 |
| 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="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
High Risk antenatal females will be screened for Hypertensive disorders of pregnancy , and then will be divided into control and interventional groups Control Group will do Home based Blood pressure monitoring and Interventional group will do Ambulatory Blood pressure monitoring for 24 hours , and then mean Blood pressure will be calculated According to this Patients will be labelled as Hypertensive or Normotensive , and patient will be managed according to Institutional protocol
|