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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024722
Receipt No. R000028441
Scientific Title A Clinical Study of Fundus Findings in Toxaemia of Pregnancy(Pregnancy Induced Hypertension)
Date of disclosure of the study information 2016/11/04
Last modified on 2016/11/04

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Basic information
Public title A Clinical Study of Fundus Findings in Toxaemia of Pregnancy(Pregnancy Induced Hypertension)
Acronym A Clinical Study of Fundus Findings in Toxaemia of Pregnancy.
Scientific Title A Clinical Study of Fundus Findings in Toxaemia of Pregnancy(Pregnancy Induced Hypertension)
Scientific Title:Acronym A Clinical Study of Fundus Findings in Toxaemia of Pregnancy.
Region
Asia(except Japan)

Condition
Condition Pregnancy Induced Hypertension(PIH).
Classification by specialty
Medicine in general Endocrinology and Metabolism Clinical immunology
Obsterics and gynecology Pediatrics Ophthalmology
Emergency medicine Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the role of ophthalmoscopy in pregnancy induced hypertension (PIH) in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.
Basic objectives2 Others
Basic objectives -Others To study the role of ophthalmoscopy in pregnancy induced hypertension (PIH) in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes In our study out of three hundred cases of pregnancy induced hypertension there are one hundred and eighty two cases of mild preeclampsia and seventy six cases of severe preeclampsia and forty two cases of eclampsia. Among these thirty seven cases of mild preeclampsia and seventy five cases of severe preeclampsia and forty one cases of eclampsia show positive fundus changes.The incidence of pre term babies intra uterine death still birth and low birth weight infants is high in mothers having positive fundus changes. The perinatal mortality is higher in patients having Grade Two Three and Four hypertensive retinopathy
Key secondary outcomes The incidence of pre term babies intra uterine death still birth and low birth weight infants is high in mothers having positive fundus changes. The perinatal mortality is higher in patients having Grade Two Three and Four hypertensive retinopathy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
42 years-old >=
Gender Female
Key inclusion criteria 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.Cases of Pregnancy Induced Hypertension.
Key exclusion criteria Cases complicated by malignancy,renal,liver or any other secondary manifestations.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr.Rahul Navinchandra Bakhda M.S.(Ophthal)
Organization Ex-Resident, M and J Western Regional
Institute of Ophthalmology, Ahmedabad
Division name Consultant Ophthalmologist.
Zip code
Address Rachana,2 New Gulabnagar Society, Raiya Road, Rajkot 360007.Gujarat.India. Clinic- Bakhda eye care clinic, 306 Surya Arcade, 1/12 Panchnath Plot,Rajkot.
TEL +91-281-2475297
Email bakhdaeyecareclinic@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Dr.Rahul Navinchandra Bakhda M.S.(Ophthal)
Organization Ex-Resident, M and J Western Regional Institute of Ophthalmology, Ahmedabad
Division name Consultant Ophthalmologist.
Zip code
Address Bakhda eye care clinic, 306 Surya Arcade, 1/12 Panchnath Plot,Rajkot
TEL +91-281-2475297
Homepage URL
Email bakhdaeyecareclinic@gmail.com

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

Funding Source
Organization Postgraduation Thesis.
M and J Western Regional Institute of
Ophthalmology,
B.J.Medical College and Civil Hospital
Campus, Ahmedabad-380016.Gujarat.India.
07922680360
07922680314
Fax:07922680360
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Indian

Other related organizations
Co-sponsor Postgraduation Thesis.
M and J Western Regional Institute of
Ophthalmology,
B.J.Medical College and Civil Hospital
Campus, Ahmedabad-380016.Gujarat.India.
07922680360
07922680314
Fax:07922680360
Name of secondary funder(s) Postgraduation Thesis.None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions M and J Western Regional Institute of Ophthalmology,
B.J.Medical College and Civil Hospital Campus,
Ahmedabad-380016.Gujarat.India.Affiliated with Gujarat University.

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 Day

Related information
URL releasing protocol http://www.jfmpc.com/text.asp?2016/5/2/424/192364
Publication of results Published

Result
URL related to results and publications http://www.jfmpc.com/text.asp?2016/5/2/424/192364
Number of participants that the trial has enrolled
Results
Clinical Study of Fundus Findings in Pregnancy Induced Hypertension (PIH). Background and Objectives: To study the role of ophthalmoscopy in pregnancy induced hypertension (PIH) in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment. Materials and Methods: An observational study in which all the patients for the study are selected from antenatal clinic, antenatal wards and preeclampsia and eclampsia room in Department of Obstetrics and Gynecology, General Ophthalmic Out Patient Department (OPD) in case of ambulatory patients, during the period of 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. Results: In our study out of 300 cases of PIH, there are 182 cases of mild preeclampsia and 76 cases of severe preeclampsia and 42 cases of eclampsia. Among these, 37 cases (20.33%) of mild preeclampsia and 75 cases (98.68%) of severe preeclampsia and 41 cases (97.62%) of eclampsia show positive fundus changes. The incidence of pre-term babies, intra uterine death, still birth and low birth weight infants is high in mothers having positive fundus changes, i.e. for pre-term infant (72.46%), still birth (62%) and low birth weight (45.56%) in our series The perinatal mortality is higher in patients having Grade II (33.85%), Grade III (54.29%), Grade IV (100%) hypertensive retinopathy. Conclusion: Retinal examination reveals important objective information in PIH, furthers their accurate diagnosis and refines their management.

Keywords: Fundus findings, pregnancy induced hypertension, hypertensive disorders of pregnancy, ophthalmoscopy, perinatal mortality
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2003 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2003 Year 11 Month 15 Day
Last follow-up date
2006 Year 06 Month 30 Day
Date of closure to data entry
2006 Year 06 Month 30 Day
Date trial data considered complete
2006 Year 06 Month 30 Day
Date analysis concluded
2006 Year 07 Month 31 Day

Other
Other related information Postgraduation Thesis.Observational Clinical Study.

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2016 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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