| CTRI Number |
CTRI/2025/11/097359 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective comparative |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of ratio blood levels of elements calcium and magnesium ratio in pregnant females with and without raised BP in pregnancy. |
|
Scientific Title of Study
|
Comparison of serum calcium-magnesium ratio in women with and without Preeclampsia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Thawale |
| Designation |
PG resident |
| Affiliation |
RML HOSPITAL |
| Address |
Department of Obstetrics & Gynaecology
ABVIMS & Dr RML hospital, Baba Kharak Singh Marg, New Delhi
Central
DELHI
110001
India |
| Phone |
09265108163 |
| Fax |
|
| Email |
nehathawale022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Chawla |
| Designation |
Professor |
| Affiliation |
RML Hospital |
| Address |
507,fifth floor, PGI building
RML campus
New Delhi
DELHI
110001
India |
| Phone |
9871115949 |
| Fax |
|
| Email |
jayachawla51@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Chawla |
| Designation |
Professor |
| Affiliation |
RML Hospital |
| Address |
Room number 507, Fifth floor, administrative building, ABVIMS & Dr RML Hospital, New Delhi
ABVIMS & Dr RML Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9871115949 |
| Fax |
|
| Email |
jayachawla51@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. RML Hospital, New delhi,110001, INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Neha Thawale |
| Address |
RML Hospital |
| Type of Sponsor |
Other [Dr. Neha Thawale] |
|
|
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 NEHA THAWALE |
Dr. RML HOSPITAL and ABVIMS |
Department of Obstetrics and Gynaecology, RML Hospital, Baba Kharak Singh Marg, New Delhi.
New Delhi
DELHI |
9265108163
nehathawale022@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnant women between 18 to 35 years with singleton live pregnancy. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Singleton live pregnancy with Preeclampsia |
|
| ExclusionCriteria |
| Details |
Any chronic medical disorders such as chronic hypertension, autoimmune disease, APLA, chronic renal disease, thyroid disease, diabetes,women on magnesium supplements, known aneuploidy or gross congenital malformation in the baby |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| calcium to magnesium ratio in maternal samples |
at the time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
calcium to magnesium ratio in cord blood
birth weight
gestational age at birth
admission to nicu |
after birth of baby within 1 week |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
25/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective comparative study will be performed in the Department of Obstetrics and Gynaecology, ABVIMS and Dr RML Hospital, NEW DELHI. Pregnant women admitted to the maternity ward of the department with the diagnosis of PE shall be screened. Those found meeting the inclusion and exclusion criteria shall be recruited after detailed written informed consent to participate. History, examination and clinical management shall be recorded as per attached proforma. Gestational age shall be determined by patients last menstrual period for those who are sure of her dates with regular cycles, otherwise it will be by measurement of foetal crown rump length at 11-13 weeks and 6 days or by the foetal trans-cerebellar diameter at 19-24 weeks. Recruited patients shall have their serum samples taken for measurement of total calcium and magnesium levels and their ratio shall be recorded. The recruited patients shall be managed as per hospital protocol and followed up until delivery. Sample for calcium and magnesium shall be taken from age and gestational age matched controls attending the antenatal OPD of the department. Serum calcium – magnesium ratio shall be recorded and compared in women with pre-eclampsia and normotensive pregnant women. Both groups shall be followed until birth and pregnancy outcome shall be recorded as per the proforma. Feto-maternal outcome shall be compared in women who develop pre- eclampsia and normotensive pregnant women. In addition, cord blood samples shall be collected to assess levels of serum calcium and magnesium. 1.0 millilitres of venous cord blood shall be collected in heparinised vials and total calcium and magnesium shall be sent to the laboratory for measurement using blood gas analyser. The values shall be compared.
|