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Clinical Trials/CTRI/2025/10/096258
CTRI/2025/10/096258
Not yet recruiting
Not Applicable

A Study Of Impact Of Comprehensive Vascular Symptom Management For Pregnancy- Induced Hypertension On Maternal Well Being And Neonatal Outcomes

Shaini PC1 site in 1 country210 target enrollmentStarted: November 10, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Shaini PC
Enrollment
210
Locations
1
Primary Endpoint
Improvement in maternal well being such as reduction in blood pressure decreased risk of complications and increased birth weight reduce risk of preterm labor distress

Overview

Brief Summary

This is a randomized controlled double blinded parallel group trial evaluate the impact of comprehensive vascular symptom management intervention in anti natal women with pregnancy induced hypertension in three phases from second trimester to third trimester in 210 anti natal women in one setting in India The Primary outcome of the study is to reduced the blood pressure other symptoms and risk of complications both mother and neonate for six month duration The secondary outcomes will be the maternal well being and neonatal reduction of risk of admission in NICU and complications

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
19.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Antenatal women after 24 weeks (6months) of gestation.

Exclusion Criteria

  • Antenatal women before 24 weeks of gestation ,who have chronic hypertension ,critically ill or convulsions.

Outcomes

Primary Outcomes

Improvement in maternal well being such as reduction in blood pressure decreased risk of complications and increased birth weight reduce risk of preterm labor distress

Time Frame: 6months

Secondary Outcomes

  • Quality of life physical emotional(reduced risk hospitalization and of NICU admission)

Investigators

Sponsor
Shaini PC
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Shaini PC

Teerthanker Mahaveer University

Study Sites (1)

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