Ambulatory blood pressure monitoring vs home based blood pressure monitoring in high risk pregnant females

Not yet recruiting

Conditions: antenatal females with High risk for hypertension

Registration Number: CTRI/2022/06/042956

Lead Sponsor: AIIMS Jodhpur

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 104

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): AIIMS jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
DR RAJIV KUMAR
Principal investigator
8005634133
rajivmeel097@gmail.com