| CTRI Number |
CTRI/2021/03/032346 [Registered on: 26/03/2021] Trial Registered Prospectively |
| Last Modified On: |
20/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Vitamic C and E in high blood pressure during pregnancy |
|
Scientific Title of Study
|
Effect of antioxidant in women at risk of developing preeclamsia – A placebo controlled double blind randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nivedita |
| Designation |
Assistant professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Obstetrics and Gynaecology, JIPMER
Dhanvantry nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09487581663 |
| Fax |
|
| Email |
dr.niveditajha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nivedita |
| Designation |
Assistant professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Obstetrics and Gynaecology, JIPMER, Puducherry
Dhanvantry Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09487581663 |
| Fax |
|
| Email |
dr.niveditajha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nivedita |
| Designation |
Assistant professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Obstetrics and Gynaecology, JIPMER
Dhanvantry Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09487581663 |
| Fax |
|
| Email |
dr.niveditajha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER pONDICHERRY |
| Address |
Dhanvantry nagar, Puducherry, 605006 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| none |
none |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nivedita |
JIPMER |
Room no 1, Department of Obstetrics and GynaecologyPuducherry
Pondicherry
PONDICHERRY |
09487581663
dr.niveditajha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Crystalline dextrose, oral, once daily |
| Intervention |
Vit C (1000 MG) and Vit E (400 IU) and Placebo |
1000 mg of Vitc and 400 IU of Vit E
Route of administration-oral
Frequency of administration- once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria:
Pregnant women presenting in antenatal clinic of JIPMR between 14- 22 weeks of gestation with one or more risks factors
a. preeclampsia/eclampsia in previous pregnancy,
b. chronic hypertension,
c. renal disease,
d. HELLP syndrome in prior pregnancy,
e. pregestational diabetes,
f. women with BMI 30 kg/m2,
g. antiphospholipid syndromes,
h. multifetal pregnancy,
i. thrombophilia,
j. Assisted reproductive technique conception,
k. age more than 35 years |
|
| ExclusionCriteria |
| Details |
B. Exclusion criteria:
1. Pregnant women less than 18 years
2. Women with known cardiac lesion
3. Women with known chronic respiratory disease (Tuberculosis, COPD, Bronchial asthma)
4.Women receiving warfarin therapy
5.Women unable to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome measure includes incidence of preeclampsia/eclampsia, early onset preeclampsia. |
in third trimester of pregnancy, and early postpartum period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal and fetal complications
Systolic and Diastolic function |
pregnancy and postpartum period |
|
|
Target Sample Size
|
Total Sample Size="721"
Sample Size from India="721"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2021 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - REQUEST TO PRINCIPAL Investigator
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2027?
Response (Others) - after publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NONE
|
Brief Summary
Modification(s)
|
Pregnant women at high risk for developing preeclampsia will be randomized to receive Vitc (1000 mg) and Vit E (400 IU) or placebo (crystalline dextrose). Women will be watched for development of preeclampsia, maternal and fetal complications. Additionally, echocardiographic parameters will be obtained to find the effect of antioxidant on systolic and diastolic function. |