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A Clinical Study of Fundus Findings in Toxaemia of Pregnancy

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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

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.


Condition or disease Intervention/treatment
Hypertension, Pregnancy-Induced 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.


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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Clinical Study of Fundus Findings in Toxaemia of Pregnancy (Pregnancy Induced Hypertension)
Study Start Date : November 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.


  6. 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.


  7. 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.


  8. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Cases of Pregnancy Induced Hypertension.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076619


Locations
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India
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., India, 380016
Sponsors and Collaborators
B. J. Medical College, Ahmedabad
M and J Western Regional Institute of Ophthalmology,Ahmedabad.
Investigators
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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

Additional Information:
Publications of Results:
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Responsible Party: Dr.Rahul Navinchandra Bakhda MS., Consultant Ophthalmologist, Ex-Resident, M and J Western Regional Institute of Ophthalmology, B. J. Medical College, Ahmedabad
ClinicalTrials.gov Identifier: NCT03076619     History of Changes
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) )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr.Rahul Navinchandra Bakhda MS., B. J. Medical College, Ahmedabad:
pregnancy induced hypertension
ophthalmoscopy
Additional relevant MeSH terms:
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Toxemia
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Infection