Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 148 for:    severe preeclampsia AND hypertensive disorders

A Clinical Study of Fundus Findings in Toxaemia of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076619
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
M and J Western Regional Institute of Ophthalmology,Ahmedabad.
Information provided by (Responsible Party):
Dr.Rahul Navinchandra Bakhda MS., B. J. Medical College, Ahmedabad

Tracking Information
First Submitted Date October 30, 2016
First Posted Date March 10, 2017
Last Update Posted Date March 13, 2017
Study Start Date November 2003
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2017)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures
 (submitted: March 6, 2017)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • The relation of number of cases of PIH and fundus findings with diastolic blood presure [ 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.
  • 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.
  • 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
Change History Complete list of historical versions of study NCT03076619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 6, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Clinical Study of Fundus Findings in Toxaemia of Pregnancy
Official Title A Clinical Study of Fundus Findings in Toxaemia of Pregnancy (Pregnancy Induced Hypertension)
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.

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
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hypertension, Pregnancy-Induced
Intervention Other: clinical ophthalmoscopy
To study the role of clinical ophthalmoscopy in PIH in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.
Study Groups/Cohorts 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.
Intervention: Other: clinical ophthalmoscopy
Publications * Bakhda RN. Clinical study of fundus findings in pregnancy induced hypertension. J Family Med Prim Care. 2016 Apr-Jun;5(2):424-429.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2017)
300
Original Actual Enrollment Same as current
Actual Study Completion Date June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Cases of Pregnancy Induced Hypertension.

Exclusion Criteria:

  • Cases complicated by malignancy, renal, liver or other secondary manifestations.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03076619
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) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr.Rahul Navinchandra Bakhda MS., B. J. Medical College, Ahmedabad
Study 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
PRS Account B. J. Medical College, Ahmedabad
Verification Date March 2017