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CTRI Number  CTRI/2022/09/045801 [Registered on: 23/09/2022] Trial Registered Prospectively
Last Modified On: 04/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Self BP monitoring at home]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Blood pressure monitoring in hypertensive antenatal women 
Scientific Title of Study   Home blood pressure monitoring for optimum blood pressure control in women with hypertensive disorders of pregnancy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manisha Kumar  
Designation  Director Professor Department of obstetrics and gynaecology 
Affiliation  Lady Hardinge Medical college , Delhi 
Address  Department of obstetrics and gynaecology, Lady hardinge medical college

Central
DELHI
110001
India 
Phone  9818014887  
Fax    
Email  manishaonly@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhawana Meena 
Designation  Post graduate Lady Hardinge Medical College  
Affiliation  Lady hardinge medical college  
Address  Department of obstetrics and gynaecology LHMC dELHI

Central
DELHI
110001
India 
Phone  7838860131  
Fax    
Email  bhawanameena1001@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhawana Meena 
Designation  Post graduate Lady Hardinge Medical College  
Affiliation  Lady hardinge medical college  
Address  Department of obstetrics and gynaecology LHMC dELHI

Central
DELHI
110001
India 
Phone  7838860131  
Fax    
Email  bhawanameena1001@gmail.com  
 
Source of Monetary or Material Support  
Department of obstetrics and gynaecology Lady hardinge medical college Delhi  
 
Primary Sponsor  
Name  Department of obstetrics and gynaecology LHMC 
Address  Department of obstetrics and gynaecology Lady hardinge medical college Delhi 
Type of Sponsor  Government medical college 
 
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 Bhawana Meena  Lady hardinge medical college Delhi  Department of obstetrics and gynaecology Lady hardinge medical college
Central
DELHI 		 7838860131

bhawanameena1001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committe lady hardinge medical college New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O133||Gestational [pregnancy-induced] hypertension without significant proteinuria, third trimester,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Optimum control of BP  Weekly monitoring of BP from 32-36 weeks till delivery 
Intervention  Self monitoring of BP  Eligible cases for home BP monitoring were instructed on how to measure blood pressure accurately. To reduce in accurate readings, an appropriate size cuff was used (length1.5 times upper arm circumference or a cuff with a bladder that encircles 80% or more of the arm). The blood pressure levels were taken with the appropriately-sized cuff with the women in an upright position with back supported and legs uncrossed. The subject’s arm was kept at the level of the heart. The reading were taken after a 5 minute period of rest in sitting position, without thick clothing on the arm. Validated automated BP machine was used for BP monitoring. The machine and the technique used by the subject was checked for accuracy by comparing 2 sets of readings with a validated blood pressure monitoring machine on ANC visit. Women on HBPM were asked to measure her blood pressure once daily in the morning between 10 am- 11am. Group B i.e standard care6 group women got their BP checked by clinician at least twice weekly (as per NICE guidelines). Both groups were asked to maintain a record of blood pressure readings as per the chart. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Antenatal women between 32-36 weeks gestation diagnosed as having chronic or gestational hypertension
Women having systolic blood pressure range 140-150 mmHg or diastolic BP range 90-100 mm Hg
Cases of chronic or gestational HTN with systolic BP <150 mmHg or diastolic BP <100 mmHg with or without drugs.
Women willing to do BP monitoring by themselves and by clinician.
 
 
ExclusionCriteria 
Details  • Women with diagnosed Preeclampsia
• Ultrasound showing fetal growth restriction with absent or reverse end diastolic flow on Doppler
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The mean BP of women with HBPM and those on standard care
Proportion of women requiring intervention in cases and control.
Proportion of women on HBPM having mean blood pressure
135/85, 135-150/85-100,more than 150/100 compared to controls
Proportion of women showing adherance.
 		 Every one week till delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of stay in hospital among study subjects
Proportion of women having adverse maternal outcome  		 Every one week till delivery 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="170" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2022 
Date of Study Completion (India) 31/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

HYPOTHESIS

 

Home blood pressure monitoring is a effective modality for optimum blood pressure control in women with hypertensive disorders of pregnancy.

 

 

AIM

 

To study the performance of home blood pressure monitoring for optimum blood pressure control in women with hypertensive disorders of pregnancy.

 

 

OBJECTIVES

 

Primary Objective-

 

·         To compare the average BP records in women with HDP on home blood pressure monitoring and on standard care

·         To determine adherence* to home blood pressure monitoring in women with HDP

 Secondary Objective

·         To compare the usage of health resources by women on home blood pressure monitoring and those on standard care.( hospital admissions and hospital stay of mother)

 

 
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