A Clinical Study of Fundus Findings in Toxaemia of Pregnancy
6 other identifiers
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Nov 2003
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 30, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedMarch 13, 2017
March 1, 2017
2.6 years
October 30, 2016
March 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
The relation of positive fundus changes with number of cases of pregnancy induced hypertension
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.
Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH and positive fundus findings with number of gravida
Correlation of fundus changes with gravida.
Nov. 2003 to June 2006 randomly
Relationship between total number of cases of PIH and fundus changes according to age
Correlation of fundus changes with age.
Nov. 2003 to June 2006 randomly
Relationship between number of cases of PIH and fundus changes according to duration of pregnancy
Correlation of fundus changes with duration of pregnancy
Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH and fundus findings with systolic blood pressure
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.
Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH and fundus findings with diastolic blood pressure
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.
Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH according to fundus changes (according to modified Keith, Wagner and Barker classification)
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.
Nov. 2003 to June 2006 randomly
The relation of individual fundus findings with no. of cases of PIH
Significance of individual fundus changes were noted
Nov. 2003 to June 2006 randomly
Secondary Outcomes (2)
Distribution of PIH cases on fetal outcome
Nov. 2003 to June 2006 randomly
The relation of fundus changes with perinatal mortality
Nov. 2003 to June 2006 randomly
Study Arms (1)
Clinical ophthalmoscopy in PIH
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 OPD in case of ambulatory patients during the period of November 2003 to June 2006 randomly.
Interventions
To study the role of clinical ophthalmoscopy in PIH in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.
Eligibility Criteria
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 OPD in case of ambulatory patients during the period of November 2003 to June 2006 randomly.
You may qualify if:
- Cases of Pregnancy Induced Hypertension.
You may not qualify if:
- Cases complicated by malignancy, renal, liver or other secondary manifestations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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
Related Publications (1)
Bakhda RN. Clinical study of fundus findings in pregnancy induced hypertension. J Family Med Prim Care. 2016 Apr-Jun;5(2):424-429. doi: 10.4103/2249-4863.192364.
PMID: 27843854RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr.Rahul Bakhda, M.S.
Ex-Resident,M and J Western Regional Institute of Ophthalmology, B.J.Medical College and Civil Hospital Campus, Ahmedabad-380016.Gujarat. 07922680360 07922680314 Fax:07922680360
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Ophthalmologist, Ex-Resident, M and J Western Regional Institute of Ophthalmology
Study Record Dates
First Submitted
October 30, 2016
First Posted
March 10, 2017
Study Start
November 1, 2003
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
March 13, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share