Hypertension, Pregnancy-InducedNCT03076619
A Clinical Study of Fundus Findings in Toxaemia of Pregnancy
An observational study of Hypertension, Pregnancy-Induced, run by B. J. Medical College, Ahmedabad at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced
- What is being tested?
- clinical ophthalmoscopy
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2003to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Cases of Pregnancy Induced Hypertension.
Who cannot join
- Cases complicated by malignancy, renal, liver or other secondary manifestations.
Trial locations and contacts
1 site in 1 country.
India1 site
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, 380016
About this study
Official title: A Clinical Study of Fundus Findings in Toxaemia of Pregnancy (Pregnancy Induced Hypertension)
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.
Read more
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.
Read the 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.
- Conditions
- Hypertension, Pregnancy-Induced
- Being tested
- clinical ophthalmoscopy
- Keywords
- pregnancy induced hypertension, ophthalmoscopy
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical ophthalmoscopyOther
To study the role of clinical ophthalmoscopy in PIH in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: clinical ophthalmoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relation of positive fundus changes with number of cases of pregnancy induced hypertension
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.
Measured: Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH and positive fundus findings with number of gravida
Correlation of fundus changes with gravida.
Measured: Nov. 2003 to June 2006 randomly
Relationship between total number of cases of PIH and fundus changes according to age
Correlation of fundus changes with age.
Measured: Nov. 2003 to June 2006 randomly
Relationship between number of cases of PIH and fundus changes according to duration of pregnancy
Correlation of fundus changes with duration of pregnancy
Measured: Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH and fundus findings with systolic blood pressure
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.
Measured: Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH and fundus findings with diastolic blood pressure
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.
Measured: Nov. 2003 to June 2006 randomly
The relation of number of cases of PIH according to fundus changes (according to modified Keith, Wagner and Barker classification)
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.
Measured: Nov. 2003 to June 2006 randomly
The relation of individual fundus findings with no. of cases of PIH
Significance of individual fundus changes were noted
Measured: Nov. 2003 to June 2006 randomly
Secondary outcomes (2)
Distribution of PIH cases on fetal outcome
Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome.
Measured: Nov. 2003 to June 2006 randomly
The relation of fundus changes with perinatal mortality
Assessment of prognosis as regards to vision and life (mortality) was made.i.e correlation of fundus changes with fetal outcome and perinatal mortality.
Measured: Nov. 2003 to June 2006 randomly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startNov 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. J. Medical College, Ahmedabad
- Sponsor type
- Other government
- Collaborators
- M and J Western Regional Institute of Ophthalmology,Ahmedabad.
- Responsible party
- Principal investigator, Dr.Rahul Navinchandra Bakhda MS., B. J. Medical College, Ahmedabad
- Investigators
- Dr.Rahul Bakhda, M.S., Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076619
- Sponsor's protocol ID
- Postgraduation Thesis
- Other IDs
- DRKS00011324, ChiCTR-OOC-16010171, UMIN000024722, U1111-1189-6165, TCTR20161221005
- Status last verified
- Mar 2017
- First submitted
- 30 Oct 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bakhda RN. Clinical study of fundus findings in pregnancy induced hypertension. J Family Med Prim Care. 2016 Apr-Jun;5(2):424-429. doi: 10.4103/2249-4863.192364.
PubMed 27843854
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Fundus Findings in Toxaemia of Pregnancy (Pregnancy Induced Hypertension)
- ClinicalTrials.gov ID
- NCT03076619
- Acronym / sponsor ID
- Postgraduation Thesis
- Conditions
- Hypertension, Pregnancy-Induced
- Keywords
- pregnancy induced hypertension, ophthalmoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- B. J. Medical College, AhmedabadOther government
- Collaborators
- M and J Western Regional Institute of Ophthalmology,Ahmedabad.
- Study start
- Nov 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical ophthalmoscopy in PIH | – | Other: clinical ophthalmoscopyAn 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Cases of Pregnancy Induced Hypertension.
Key exclusion criteria (1 listed)
- Cases complicated by malignancy, renal, liver or other secondary manifestations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical ophthalmoscopyTo study the role of clinical ophthalmoscopy in PIH in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment. | Other | Clinical ophthalmoscopy in PIH |
Primary outcome
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
2 secondary outcomes
Distribution of PIH cases on fetal outcome
Time frame: Nov. 2003 to June 2006 randomly
The relation of fundus changes with perinatal mortality
Time frame: Nov. 2003 to June 2006 randomly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Results publication: PubMed 27843854Bakhda RN. Clinical study of fundus findings in pregnancy induced hypertension. J Family Med Prim Care. 2016 Apr-Jun;5(2):424-429. doi: 10.4103/2249-4863.192364.
- Published articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hypertension, Pregnancy-Induced
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Rahul Bakhda, M.S. principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pregnancy-Induced, run by B. J. Medical College, Ahmedabad at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relation of positive fundus changes with number of cases of pregnancy induced hypertension (time frame: Nov. 2003 to June 2006 randomly). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.