| CTRI Number |
CTRI/2021/05/033581 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Serum calcium, magnesium and calcium magnesium ratio in women with preeclampsia |
|
Scientific Title of Study
|
Serum calcium, magnesium and calcium magnesium ratio in women with preeclampsia A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya S P Patil |
| Designation |
Junior Resident, |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No. 1 , Department of Obstetrics and Gynaecology, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka
D1429, Brigade Panorama, Mysore main road, Anchepalya, Kambipura, Bengaluru, 560060
Udupi
KARNATAKA
576104
India |
| Phone |
9980418612 |
| Fax |
|
| Email |
drpriya.sp42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaram Nambiar |
| Designation |
Professor, OBGYN |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No. 1 , Department of Obstetrics and Gynaecology, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845082923 |
| Fax |
|
| Email |
drram.nambiar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayaram Nambiar |
| Designation |
Professor, OBGYN |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No. 1 , Department of Obstetrics and Gynaecology, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845082923 |
| Fax |
|
| Email |
drram.nambiar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Priya S P Patil |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya S P Patil |
Kasturba Medical College |
Room No.1
Department of obstetrics and gynaecology
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9980418612
drpriya.sp42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
For cases
Pregnant women with a gestational age of 20 weeks or more diagnosed with preeclampsia using the standard criteria including elevated blood pressure greater than or equal to SBP 140 and DBP 90 mm Hg with proteinuria greater than 1
For controls:
Normotensive participants without dipstick proteinuria matched for age, gestational, age, and parity.
|
|
| ExclusionCriteria |
| Details |
1.Women with chronic hypertension
2.Multiple gestation pregnancy
3.Diabetic women
4.Woman with eclampsia
5.Woman with thyroid disease
6.Woman with autoimmune disease
7.Woman with renal disease
8.Woman with History of smoking or alcohol consumption
9.Woman on other drugs effecting blood pressure.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The serum calcium magnesium ratio in preeclampsia and to compare it with normotensive pregnant woman using maternal serum anylates.
2.Prevalence of hypomagnesemia and hypocalcemia among study participants
3. The association between calcium- magnesium ratio and severity of pre-eclampsia |
Serum calcium and magnesium levels will be assessed at the time of diagnosis of preeclampsia ( after 20 weeks ) and controls will be matched for the gestational age. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neonatal Outcomes |
post delivery |
| Prevalence of hypomagnesemia and hypocalcemia among study participants |
Serum calcium and magnesium levels will be assessed at the time of diagnosis of preeclampsia ( after 20 weeks ) and controls will be matched for the gestational age. |
|
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Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/05/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Written and informed consent from the patient will be taken during the booking visit. Maternal characteristics like weight, height, BMI will be noted.Demographic details like age, parity, medical, surgical, menstrual, family history of the patient will entered. General physical examination and baseline laboratory investigations be done. About 5 ml of venous blood from the antecubital vein without stasis will be collected and sent for serum calcium and magnesium analysis on OPD basis. Urinalysis will be performed using a semi qualitative method. All pregnant women included in the study will be advised to come to the antenatal care clinic monthly till 28 weeks, every 2 weeks till 36 weeks and weekly till delivery during which first, second and third trimester details will be noted. Warning signs will be clearly explained. Patients will be followed up until delivery and also till discharge from the hospital to note down the delivery and neonatal outcomes. Gestational age at delivery ,Mode of delivery, Neonatal outcomes like birth weight,APGAR score at 1 minute and 5 minutes, NICU admissions and complications will be noted. A lower serum Calcium and magnesium ratio among women with pre-eclampsia is expected.
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