Role of Maternal Ophthalmic artery Doppler in third trimester in prediction of pre-eclampsia

Not yet recruiting

• Conditions: Pregnant mothers between 34 to 37 weeks of gestation with absence of existing preeclampsia at the time of recruitment.

• Registration Number: CTRI/2021/08/036006
• Lead Sponsor: Fernandez Foundation

Brief Summary

Incidence of preeclampsia is 10% worldwide. More than70% of preeclampsia occur at term. Maternal mortality frompreeclampsia/eclampsia accounts for 63000 maternal deaths per annum worldwide,maximum being in low- middle income countries. Preeclampsia set in after 34weeks of gestation is termed as late onset PE.(2) In late onsetpreeclampsia, cause is more likely an increasing mismatch between normalmaternal perfusion and metabolic demands of the placenta and fetus, coupledwith a maternal predisposition to inflammation, high BMI or high arterialpressure.(3) Considering the rising incidence of gestationalhypertension, preeclampsia and PE associated comorbidity, various ways of earlydetection of risk of PE development in pregnancy are being researched allacross the world sincepasttwodecades.Mostofthemethodsfocusonthedetectionofearlyonsetpreeclampsiawhichconstitute about 40-50% of the cases. More than 70% cases occur at term, if ascreening method is introduced at 34 weeks, many mothers who are high risk forlate onset preeclampsia can be detected early. Ophthalmic artery indices likePSV ratio, PI are being studied world wide at present.

The study conducted by Riskin Mashiahet al & Belfort et al (13,14) supported the evidence of development of PEis preceded by the decrease in the impedance to flow in the cerebralcirculation. The ophthalmic artery, which is the first branch of the internal carotidartery has embryological, anatomical and functional similarities with the intracranialvasculature, is an easily accessible vessel for Doppler assessment thatprovides information on the less accessible intracranial circulation. Thus theuse of Ophthalmic artery in prediction of PE is recently being investigated forits role in predicting preeclampsia worldwide and found to be beneficial.

We are proposing a Prospective observational study,to be conducted at Fernandez Hospital, Hyderabad  in the Department of Fetal Medicine, with 407 Study subjects. Patientpopulation comprises of pregnant mothers visiting different branches ofFernandez Hospital for growth scan between 34 to37 weeks. Ophthalmic arterywaveforms shall be obtained in sequence from the right eye, left eye and againfrom the right and then left eye. The following three indices will be used foranalysis: first peak of systolic velocity; second peak of systolic velocity andthe ratio of the second to first peak of systolic velocity (PSV ratio). Womenwill be then followed till their childbirth and details of mean arterialpressure at the time of OPD visits in third trimester, development ofpreeclampsia or eclampsia will be collected. Data about mode of delivery,development of fetal growth restriction shall be collected from the inpatientrecords. Entire data shall be analyzed.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-08-23
• Study Start: 2021-08-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 407

Inclusion Criteria

• Singleton pregnancies between 34 to 37 weeks of gestation 2.
• Mothers who birth at Fernandez Hospital.
• Structurally normal fetuses.

Exclusion Criteria

• Multifetal pregnancies.
• Loss to follow up.
• Women with already established preeclampsia at the time of OAD examination 4.
• Gestational hypertension on treatment with tab Methyldopa.
• Women with Ocular pathologies e.g. High Myopia(>-5.00 DS), Glaucoma ,Ophthalmic Artery occlusion or Ophthalmic artery Aneurysm.
• Women with vasculopathies 7.
• Women with renal disorders causing hypertension or proteinurea.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
predictive value of PSV2/PSV 1 ratio of ophthalmic artery and development of preeclampsia or related complications.	between 34-37 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
(i)To study the correlation of PSV2/PSV 1 ratio of ophthalmic artery with Demographic characteristics e.g.	•Age

Trial Locations

Locations (1)

Fernandez Hospital unit 4; 🇮🇳 Hyderabad, TELANGANA, India

Fernandez Hospital unit 4

🇮🇳Hyderabad, TELANGANA, India

Dr Priyanka Paradkar

Principal investigator

9004857096

priyanshva@gmail.com