UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024722 |
|---|---|
| Receipt number | 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 23:33:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 |
| Obstetrics 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
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
bakhdaeyecareclinic@gmail.com
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028441
