Role of measuring blood supply of eye with other biophysical markers at 19-24 weeks in detecting development of high blood pressure in pregnancy

Not yet recruiting

• Conditions: pregnant ladies; Unspecified pre-eclampsia,

• Registration Number: CTRI/2021/10/037200
• Lead Sponsor: Fernandez Hospital Foundation

Brief Summary

Screening and prevention of pre-eclampsia are major health goals of maternal healthcare worldwide. Apart from uterine artery, several peripheral vessel doppler indices have been investigated as a potential marker for the development of pre-eclampsia, among which Ophthalmic Artery Doppler is one among them.

Objective of this study is to evaluate Ophthalmic Artery Doppler at 19-24weeks of gestation alone or in combination with biophysical markers (maternal factors, Uterine artery PI, mean arterial pressure) to predict pre-eclampsia and to see its predictive value for gestation age at birth.

It would be a 1 year prospective observational study to be conducted in Fetal Medicine unit of Fernandez Hospital Foundation. All singleton mothers booked before 24weeks, fullfilling inclusion criterias during the study period will be enrolled for the study. Informed consent will be obtained at the time of screening. Recording of maternal demographic characteristics, medical history, mean arterial pressure will be recorded. Mid trimester anomaly scan, Uterine artery PI, Ophthalmic artery indices will be checked in a same scan setting. Ophthalmic artery indices-PSV1,PSV2, PSV ratio will be measured. Average of 4 measurement will be taken. They will be followed up till delivery and discharge from hospital.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 575

Inclusion Criteria

•All singleton mothers booked before 24 weeks •Mothers who birth at Fernandez Hospital •Singleton pregnancies with structurally normal fetus between 19-24 weeks •Population who are unscreened for preeclampsia in first trimester.

Exclusion Criteria

1.Pregnancies with aneuploidy and major fetal abnormality 2.Multifetal pregnancy 3.Miscarriage or fetal death before 26 weeks 3.Loss to follow up 4.Screened for pre-eclampsia in first trimester 5.Mothers with renal disease causing hypertension and proteinuria 6.Mothers with ocular/ ophthalmic artery pathologies using vasodilating drug.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To predict preterm PE (37 weeks) and term PE (≥37weeks) using Opthalmic artery doppler	After delivery and discharge from the hospital.

Secondary Outcome Measures

Name	Time	Method
Preterm and term delivery and development of pre-eclampsia using Ophthalmic artery doppler, Uterine artery PI, mean arterial pressure.	1 year

Trial Locations

Locations (1)

Fernandez Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Fernandez Hospital

🇮🇳Hyderabad, TELANGANA, India

Dr Tseten Zangmu Bhutia

Principal investigator

7005456277

tstnzangmu@gmail.com