Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03076619
Study type Observational
Source B. J. Medical College, Ahmedabad
Contact
Status Completed
Phase N/A
Start date November 2003
Completion date June 2006

See also
  Status Clinical Trial Phase
Completed NCT03613714 - Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy N/A
Completed NCT02338687 - Low Dose Calcium to Prevent Preeclampsia Phase 4
Completed NCT04752475 - Lasix for the Prevention of De Novo Postpartum Hypertension Phase 3
Completed NCT03334149 - Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension N/A
Recruiting NCT03298802 - Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide Phase 3
Recruiting NCT05473767 - Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children N/A
Completed NCT03356106 - Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy N/A
Recruiting NCT05849103 - Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy N/A
Recruiting NCT03200743 - Catestatin and Hypertension in Pregnancy N/A
Terminated NCT04343235 - Postpartum Management of Gestational Hypertensive Disorders Using Furosemide Phase 4
Completed NCT01508208 - Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders N/A
Active, not recruiting NCT04580927 - Breastfeeding and Postpartum Cardiovascular Health N/A
Recruiting NCT03858595 - Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy N/A
Recruiting NCT05655936 - Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial N/A
Completed NCT01736826 - Free DNA and Nucleosome Concentrations in Pathological Pregnancies
Completed NCT02523781 - Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy N/A
Completed NCT03556761 - Furosemide for Accelerated Recovery of Blood Pressure Postpartum Phase 2
Completed NCT00949260 - Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance N/A
Active, not recruiting NCT04012151 - Arm and Finger Measurement for Blood Pressure Surveillance
Completed NCT04615624 - Furosemide vs. Placebo for Severe Antepartum Hypertension Phase 3