| CTRI Number |
CTRI/2021/03/031734 [Registered on: 05/03/2021] Trial Registered Prospectively |
| Last Modified On: |
21/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY ON THE ROLE OF ASPIRIN IN PREVENTING PRETERM BIRTH |
|
Scientific Title of Study
|
LOW DOSE ASPIRIN FOR THE PREVENTION OF SPONTANEOUS PRETERM LABOUR IN WOMEN AT RISK FOR PRETERM BIRTH |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanu Sharma |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Obstetrics and Gynaecology,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219051719 |
| Fax |
|
| Email |
keepintouch.2008@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Suri |
| Designation |
Head of Department |
| Affiliation |
PGIMER |
| Address |
Department of Obstetrics and Gynaecology,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209346 |
| Fax |
|
| Email |
surivanita@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanu Sharma |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Obstetrics and Gynaecology,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219051719 |
| Fax |
|
| Email |
keepintouch.2008@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Chandigarh |
| Type of Sponsor |
Research institution |
|
|
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 |
| Tanu Sharma |
PGIMER,Chandigarh |
Room no 2032,2042 New OPD
Department of Obstetrics and Gynaecology
Chandigarh
CHANDIGARH |
8219051719
keepintouch.2008@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aspirin |
Low dose aspirin will be given to antenatal women between 6 to 16 weeks of gestation at risk for preterm birth apart from routine antenatal treatment
75 mg once daily dose will be given by oral route |
| Comparator Agent |
nil |
Control group will receive routine antenatal treatment given to those at risk for preterm birth |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal Women between 6 to 16 weeks of gestation
Singleton Pregnancy
History of previous spontaneous preterm birth and/or PPROM or history of second trimester abortion |
|
| ExclusionCriteria |
| Details |
Previous indicated preterm birth for maternal or fetal reasons
Contraindications to aspirin use
Major fetal malformations in current or previous pregnancy
Multifetal gestation
Moderate /severe anaemia
Medical comorbidities
Uterine anomalies and cervical insufficiency
At risk for preeclampsia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of preterm birth at less than 37 weeks of gestation between aspirin and non aspirin groups |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare maternal complications and neonatal outcomes between aspirin and non aspirin groups |
9 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/03/2021 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
Aspirin is a commonly prescribed drug in antenatal women at risk for preeclampsia.Secondary outcomes of studies have shown that aspirin given to women also lowered the incidence of preterm birth apart from having a protective role in preeclampsia.This study aims to see the effect of aspirin in reducing incidence of preterm birth in women at risk.Aspirin is a cheap intervention and could prove useful in low resource settings if found effective. |