A Clinical Study of Fundus Findings in Toxaemia of Pregnancy (Pregnancy Induced Hypertension)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Relationship between number of cases of PIH and fundus changes according to duration of pregnancy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cases of Pregnancy Induced Hypertension.
排除标准
- •Cases complicated by malignancy, renal, liver or other secondary manifestations.
结局指标
主要结局
Relationship between number of cases of PIH and fundus changes according to duration of pregnancy
时间窗: Nov. 2003 to June 2006 randomly
Correlation of fundus changes with duration of pregnancy
The relation of individual fundus findings with no. of cases of PIH
时间窗: Nov. 2003 to June 2006 randomly
Significance of individual fundus changes were noted
The relation of number of cases of PIH and fundus findings with diastolic blood pressure
时间窗: 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.
The relation of number of cases of PIH and fundus findings with systolic blood pressure
时间窗: 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.
The relation of positive fundus changes with number of cases of pregnancy induced hypertension
时间窗: 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.
The relation of number of cases of PIH and positive fundus findings with number of gravida
时间窗: Nov. 2003 to June 2006 randomly
Correlation of fundus changes with gravida.
Relationship between total number of cases of PIH and fundus changes according to age
时间窗: Nov. 2003 to June 2006 randomly
Correlation of fundus changes with age.
The relation of number of cases of PIH according to fundus changes (according to modified Keith, Wagner and Barker classification)
时间窗: 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.
次要结局
- The relation of fundus changes with perinatal mortality(Nov. 2003 to June 2006 randomly)
- Distribution of PIH cases on fetal outcome(Nov. 2003 to June 2006 randomly)
研究者
Dr.Rahul Navinchandra Bakhda MS.
Consultant Ophthalmologist, Ex-Resident, M and J Western Regional Institute of Ophthalmology
B. J. Medical College, Ahmedabad