A Clinical Study of Fundus Findings in Toxaemia of Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pregnancy-Induced
• Intervention / Treatment: Other: clinical ophthalmoscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Cases of Pregnancy Induced Hypertension.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: clinical ophthalmoscopy; To study the role of clinical ophthalmoscopy in PIH in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of PIH cases on fetal outcome	Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome.	Nov. 2003 to June 2006 randomly
The relation of fundus changes with perinatal mortality	Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome and perinatal mortality.	Nov. 2003 to June 2006 randomly

Collaborators and Investigators

• Sponsor: B. J. Medical College, Ahmedabad
• Collaborators: M and J Western Regional Institute of Ophthalmology,Ahmedabad.
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Published article

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: October 30, 2016
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: pregnancy induced hypertension; ophthalmoscopy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Pregnancy Complications; Toxemia; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: Postgraduation Thesis; DRKS00011324 (Registry Identifier: The German Clinical Trials Register -Deutsche Register Klinischer Studien); ChiCTR-OOC-16010171 (Registry Identifier: Chinese Clinical Trial Registry-ChiCTR); UMIN000024722 (Registry Identifier: UMIN Clinical Trials Registry (UMIN-CTR)); U1111-1189-6165 (Registry Identifier: International Clinical Trials Registry Platform (ICTRP)); TCTR20161221005 (Registry Identifier: Thai Clinical Trials Registry (TCTR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No