| CTRI Number |
CTRI/2025/08/093655 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Aspirin on Neurofilament Light Chain in Preeclampsia Patients |
|
Scientific Title of Study
|
Evaluation of the effect of Low dose Aspirin on plasma concentration of Neurofilament Light Chain (NfL) in moderate to high risk preeclampsia patients compared to low risk pregnant females and to correlate NfL levels with maternal and fetal outcomes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharmila Jalgaonkar |
| Designation |
Professor (Additional) |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8108426522 |
| Fax |
|
| Email |
sharmila_jalgaonkar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Unnati Bhatnagar |
| Designation |
Post graduate resident |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8556884375 |
| Fax |
|
| Email |
unnatibhatngara4085@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Jalgaonkar |
| Designation |
Professor (Additional) |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8108426522 |
| Fax |
|
| Email |
sharmila_jalgaonkar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sharmila Jalgaonkar |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai- 400012 |
| Type of Sponsor |
Other [self] |
|
|
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 Sharmila Jalgaonkar |
King Edward Memorial Hospital |
ANC OPD, Department of Obstetrics and Gynecology, Seth GS Medical College and King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
8108426522
sharmila_jalgaonkar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- III, Relating to Biomedical and Health Research (BHR), Seth GS Medical college and KEM Hospital, Mumbai, Maharastra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant patients classified as moderate to high risk for pre-eclampsia at 12-16 weeks of gestation according to FOGSI guidelines, to be started on aspirin prophylaxis by the attending obstetrician in the antenatal outpatient clinic.
2. Pregnant patients categorized as low risk of pre eclampsia at 12-16 weeks of gestation according to FOGSI guidelines by the attending obstetrician and not started on aspirin prophylaxis
3. Patients with age above 18 years
4. Intra uterine pregnancy
5. Patients planning to have delivery in KEM Hospital |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed consent
2. Patients admitted in IPD and emergency department for causes not related to pregnancy
3. Chronic Kidney Disease
4. Contraindication to Aspirin |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum concentration of NfL in moderate to high risk patients and low risk patients of pre-eclampsia |
1. Baseline Value (Visit 0)- 12-16 weeks
2. Visit 1- 24-26 weeks
3. Visit 2- 32-34 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Variables: Observe patients for the development of-
Maternal Clinical Outcomes:
1. Gestational hypertension
2. Pre-eclampsia
3. Eclampsia
4. Abruptio Placenta
Fetal :
1. Gestational age at termination of pregnancy
2. Intrauterine fetal demise / stillbirth
Neonatal-
1. Birth weight
2. Neonatal ICU admission due to complications |
1. Baseline visit (Visit 0)- 12-16 weeks
2. Visit 1- 24-26 weeks
3. Visit 2- 32-34 weeks
4. Visit 3-Delivery
5. Visit 4-One month post partum |
Biochemical variables :
1. Proteinuria
2. HELLP syndrome (according to Tennessee classification system) |
1. Baseline visit (Visit 0)- 12-16 weeks
2. Visit 1- 24-26 weeks
3. Visit 2- 32-34 weeks
4. Visit 3- Delivery
5. Visit 4- One month post partum |
Radiological variables:
Maternal (uterine artery doppler):
1. Pulsatility index
2. Resistance index
3. Systolic diastolic ratio
4. Presence of diastolic notch beyond 24 weeks
Fetal: Intra uterine growth restriction
|
1. Baseline values( Visit 0)- 12-16 weeks
2. Visit 1- 24-26 weeks
3. Visit 2- 32-34 weeks
4. Visit 3- Delivery |
| Correlation between Serum NfL levels with maternal clinical outcomes, fetal clinical outcomes, neonatal clinical outcomes and radiological parameters in low risk and moderate to high risk groups |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
05/09/2025 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pre-Eclampsia is a hypertensive disorder developing in pregnant females after 20 weeks of gestation. It is defined as blood pressure more than 140/90 mm hg in patients with previously normal blood pressure readings. End organ damage is also seen in this condition which can affect major organ systems like kidney, liver and brain. The estimated prevalence in India is 10% and is a major cause of morbidity and mortality. Patients are screened for risk of pre-eclampsia according to India guidelines issued by FOGSI and are classified as low, moderate and high risk for pre-eclampsia. In moderate and high risk patients, low dose aspirin is started as a prophylactic measure. Currently, there is no pharmacological treatment of the disease and symptoms are managed accordingly using clinical, biochemical and radiological parameters. Once the disease develops, symptomatic treatment is done using lifestyle modification and pharmacological therapies with the only definitive treatment being termination of pregnancy. Due to the above reasons, patients are advised regular ANC visits for early detection and management. This study aims to assess the effect of the prophylactic drug i.e aspirin on a predictive axonal biomarker Neurofilament Light Chain (NfL). The aforesaid biomarker will be evaluated during routine ANC checkup and extra 5 ml blood will be taken for the same. Furthermore, the biomarker levels will be correlated with clinical and radiological parameters to establish it’s role as a predictive biomarker for the disease of interest. |