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NCT Number: NCT03076619

A Clinical Study of Fundus Findings in Toxaemia of Pregnancy

Toxemia of pregnancy is a recognized entity for over 2000 years with its known complications and fatality. Nowadays, a most accepted terminology for the following defined syndrome is "hypertensive disorders in pregnancy" given by American College of Obstetrics and Gynecology. It is an important cause of maternal and fetal morbidity and mortality. Pregnancy induced hypertension (PIH) was classified as gestational hypertension, preeclampsia, severe preeclampsia and eclampsia. PIH is a hypertensive disorder in pregnancy that occurs after 20 weeks of pregnancy in the absence of other causes of elevated blood pressure (BP) (BP >140/90 mmHg measured two times with at least of 4 hour interval) in combination with generalized edema and/or proteinuria (>300 mg per 24 hrs). When there is significant proteinuria it is termed as preeclampsia; seizure or coma as a consequence of PIH is termed as eclampsia. Preeclampsia was classified into mild and severe preeclampsia.

Mild eclampsia-BP >140/90 mmHg, proteinuria+, and/or mild edema of legs, Severe preeclampsia-BP >160/110 mmHg,proteinuria++ or ++++, headache, cerebral or visual disturbances, epigastric pain, impaired liver function tests and increase in serum creatinine.

Proteinuria was tested using dipstick method as +=0.3 gm/L, ++=1 gm/L, and +++=3 gm/L.

The pathological changes of this disease appear to be related to vascular endothelial dysfunction and its consequences (generalized vasospasm and capillary leak). Ocular involvement is common in PIH.Common symptoms are blurring of vision, photopsia, scotomas and diplopia. Visual symptoms may be the precursor of seizures.Progression of retinal changes correlates with progression of PIH and also with the fetal mortality due to similar vascular ischemic changes in placenta.Vasospastic manifestations are reversible and the retinal vessels rapidly return to normal after delivery. Ophthalmoscope should be rated next to the sphygmomanometer as an instrument of diagnostic importance in cases of PIH. Ophthalmoscopy does not only helps in diagnosing the disease but repeated observations assist in assessing the severity, progress of disease, response to treatment if any and ultimate outcome or prognosis.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

M and J Western Regional Institute of Ophthalmology, B.J.Medical College and Civil Hospital Campus, Ahmedabad-380016.Gujarat. 07922680360 07922680314 Fax:07922680360

Ahmedabad, Gujarat, 380016, India

About this study

An observational study in which the patients for the study are selected from antenatal clinic, antenatal ward and "preeclampsia and eclampsia room" in Department of Obstetrics and Gynecology and general Ophthalmic Out Patient Department(OPD) in case of ambulatory patients during the period of November 2003 to June 2006 randomly.In every case, detail obstetric history including a detail antenatal history was taken. General examination and relevant pathological investigations like routine blood count, HIV, HBsAg, renal function tests, TORCH complex etc., were carried out. In every case, pupil was dilated with homatropine (2%) eye drops. Then detailed ophthalmic examination was carried out with special emphasis on direct ophthalmoscopy apart from visual acuity of both eyes and anterior segment examination. Fundus findings were noted in detail, changes in the color of the disc, disc margin, physiological cup, changes in retinal blood vessels especially caliber of vessels, arterio-venous (AV) ratio,changes in vessel wall, blood column, appearance of vascular light reflex, changes at AV crossings, changes in macular area and changes in background, overall appearance, presence of hemorrhages, exudates or any pathology were recorded.

Fundus changes were graded as per modified Keith, Wagner and Barker classification.Assessment of prognosis as regards to vision and life (mortality) was made.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cases of Pregnancy Induced Hypertension.

Exclusion criteria

  • Cases complicated by malignancy, renal, liver or other secondary manifestations.

Treatment and study plan

clinical ophthalmoscopy

Other

To study the role of clinical ophthalmoscopy in PIH in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.

Primary outcomes

  1. The relation of positive fundus changes with number of cases of pregnancy induced hypertension

    Time frame: Nov. 2003 to June 2006 randomly

    Correlation of fundus changes with disease entity.In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.

  2. The relation of number of cases of PIH and positive fundus findings with number of gravida

    Time frame: Nov. 2003 to June 2006 randomly

    Correlation of fundus changes with gravida.

  3. Relationship between total number of cases of PIH and fundus changes according to age

    Time frame: Nov. 2003 to June 2006 randomly

    Correlation of fundus changes with age.

  4. Relationship between number of cases of PIH and fundus changes according to duration of pregnancy

    Time frame: Nov. 2003 to June 2006 randomly

    Correlation of fundus changes with duration of pregnancy

  5. The relation of number of cases of PIH and fundus findings with systolic blood pressure

    Time frame: Nov. 2003 to June 2006 randomly

    In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.

    Fundus findings were noted in detail.

  6. The relation of number of cases of PIH and fundus findings with diastolic blood pressure

    Time frame: Nov. 2003 to June 2006 randomly

    In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.

    Fundus findings were noted in detail.

  7. The relation of number of cases of PIH according to fundus changes (according to modified Keith, Wagner and Barker classification)

    Time frame: Nov. 2003 to June 2006 randomly

    In every case detail obstetric history, general examination and relevant pathological investigations were carried out. In every case, pupil was dilated with homatropine (2%) eye drops and detailed ophthalmic examination was carried out.

    Fundus findings were noted in detail.

  8. The relation of individual fundus findings with no. of cases of PIH

    Time frame: Nov. 2003 to June 2006 randomly

    Significance of individual fundus changes were noted

Secondary outcomes

  1. Distribution of PIH cases on fetal outcome

    Time frame: Nov. 2003 to June 2006 randomly

    Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome.

  2. The relation of fundus changes with perinatal mortality

    Time frame: Nov. 2003 to June 2006 randomly

    Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome and perinatal mortality.

Sponsors and collaborators

Lead sponsor

B. J. Medical College, Ahmedabad

Other Gov

Collaborators

  • M and J Western Regional Institute of Ophthalmology,Ahmedabad.

Registry information

Official study title

A Clinical Study of Fundus Findings in Toxaemia of Pregnancy (Pregnancy Induced Hypertension)

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Mar 10, 2017
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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