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CTRI Number  CTRI/2016/05/006970 [Registered on: 31/05/2016] Trial Registered Prospectively
Last Modified On: 02/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   ASPIRIN- Preterm Birth Prevention Study 
Scientific Title of Study   Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) 
Trial Acronym  ASPIRIN 
Secondary IDs if Any  
Secondary ID  Identifier 
GN-LDA.8.1, Version 1.1, March 21, 2015   Protocol Number 
NCT02409680  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhalachandra S Kodkany 
Designation  Emeritus Professor of OBGYN and Senior Foreign Investigator 
Affiliation  KLE Universitys J N Medical College 
Address  Womens and Childrens Health Research Unit KLE Universitys J N Medical College Nehru Nagar Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9448141470  
Fax  8312472891  
Email  drkodkany@jnmc.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology  
Affiliation  KLE Universitys J N Medical College 
Address  Womens and Childrens Health Research Unit KLE Universitys J N Medical College Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448126371  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology  
Affiliation  KLE Universitys J N Medical College 
Address  Womens and Childrens Health Research Unit KLE Universitys J N Medical College Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448126371  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Source of Monetary or Material Support  
Eunice Kennedy Shriver National Institute of Child Health and Human Development 
 
Primary Sponsor  
Name  Eunice Kennedy Shriver National Institute of Child Health and Human Development 
Address  Global Network for Womens and Childrens Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)USA 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Democratic Republic of the Congo
Guatemala
India
Kenya
Pakistan
Zambia  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhalchandra S Kodkany  Jawaharlal Nehru Medical College Belgaum  Department: Womens and Childrens Health Research Unit Institution: KLE Universitys J N Medical College, Nehru Nagar Belagavi-590010
Belgaum
KARNATAKA 		 9448141470
918312472891
drkodkany@jnmc.edu 
Archana Patel  Lata Medical Research Foundation nagpur  Lata Medical Research Foundation Number: 9/1 Kinkine Kutir Opposite to Hanuman Temple Vasant Nagar Deekshabhoomi Square Nagpur 440022
Nagpur
MAHARASHTRA 		 9823154463

Dr_apatel@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Review Committee, Lata Medical Research Foundation Nagpur  Approved 
JNMC – Institutional Ethics Committee on Human Subjects Research Belgaum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low dose Aspirin  81 mg of aspirin administered daily beginning between 6 0/7 weeks and 13 6/7 weeks through 36 0/7 weeks or delivery 
Comparator Agent  Placebo  Identical appearing placebo administered daily beginning between 6 0/7 weeks and 13 6/7 weeks through 36 0/7 weeks or delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  -Nulliparous women between 18 – 40 years of age.
-No more than two previous first trimester pregnancy losses
-No medical contraindications to aspirin;
-Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with heart rate greater than 110 bpm
 
 
ExclusionCriteria 
Details  -Women prescribed daily aspirin for more than 7 days
-Multiple gestations;
-Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion
-Hemoglobin < 7.0 gm/dl at screening
-Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, hypertension, or any other known significant disease)
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Preterm birth  delivery after 20 0/7 weeks and prior to 37 0/7 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Preeclampsia and eclampsia  upto 42 days postpartum period 
Small for Gestational age  Day of delivery 
Perinatal mortality  until 7 days after delivery  
Vaginal bleeding  Bleeding during pregnancy 
Antepartum hemorrhage  Bleeding from the genital tract at any time after the 22nd week of pregnancy and before the birth of the baby 
Postpartum hemorrhage  Blood loss of 1000 ml or more from the genital tract after delivery and up to six weeks post-delivery 
Maternal mortality   death of a woman during pregnancy (i.e. conception to delivery) and the puerperium (i.e. up to 42 days after delivery 
Change in maternal hemoglobin   Hemoglobin level less than 7.0 gm/dL or a 3.5 gm/dL decrease between measurements 
Preterm birth less than 34 0/7 weeks of pregnancy   live birth before 34 0/7 weeks of pregnancy are completed 
Fetal Loss   Spontaneous loss more than or equal to 16 weeks GA plus perinatal mortality 
Late abortion   Spontaneous fetal loss after or equal to 16 weeks 
Spontaneous abortion   Premature expulsion of a non-viable fetus from the uterus at less than 20 weeks gestation 
Stillbirth   Birth of a baby that shows no signs of life at birth  
Medical termination of pregnancy   an operation or other procedure to terminate pregnancy before the fetus is viable 
Birth weight less than 2500g and 1500g  At Delivery 
 
Target Sample Size   Total Sample Size="11920"
Sample Size from India="4180" 
Final Enrollment numbers achieved (Total)= "11976"
Final Enrollment numbers achieved (India)="4829" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/06/2016 
Date of Study Completion (India) 11/04/2019 
Date of First Enrollment (Global)  25/03/2016 
Date of Study Completion (Global) 11/04/2019 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, Lokangaka A, Tshefu A, Bose CL, Mwapule A, Mwenechanya M, Chomba E, Carlo WA, Chicuy J, Figueroa L, Garces A, Krebs NF, Jessani S, Zehra F, Saleem S, Goldenberg RL, Kurhe K, Das P, Patel A, Hibberd PL, Achieng E, Nyongesa P, Esamai F, Liechty EA, Goco N, Hemingway-Foday J, Moore J, Nolen TL, McClure EM, Koso-Thomas M, Miodovnik M, Silver R, Derman RJ. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Jan 25;395(10220):285-293. doi: 10.1016/S0140-6736(19)32973-3. PubMed PMID: 31982074; PubMed Central PMCID: PMC7168353. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the developed and developing world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially. Hypothesis: The investigators’ primary hypothesis is that nulliparous women with no more than two previous first trimester pregnancy losses who are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) through 36 0/7 weeks GA will reduce the rate of preterm birth from all causes. Study Design Type: Prospective randomized, placebo-controlled, double-blinded multicenter clinical trial (patient level 1:1). Population: Nulliparous women between the ages of 18 and 40 with no more than two previous first trimester pregnancy losses or any second trimester spontaneous pregnancy loss, a singleton pregnancy between 6 0/7 weeks and 12 6/7 weeks GA confirmed by ultrasound, and no contraindications to aspirin. Intervention: Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA)], initiated between 6 0/7 weeks and 12 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly. Outcomes: The primary outcome is to determine whether daily LDA initiated between 6 0/7 weeks and 12 6/7 weeks and continued to 36 0/7 weeks reduces the risk of preterm birth (birth prior to 37 0/7 weeks of pregnancy) by 20%. This will be determined based on assessed date of delivery in comparison to the projected estimated date of delivery, independent of whether or not the preterm delivery is iatrogenic or spontaneous. Secondary outcomes include:Preeclampsia and eclampsia, SGA,Perinatal mortality,Other secondary outcomes of interest are:Maternal outcomes:Vaginal bleeding, Antepartum hemorrhage,Postpartum hemorrhage,Maternal mortality,Late abortion,Change in maternal hemoglobin,Fetal outcomes: Rate of preterm birth <34 0/7 weeks of pregnancy,Birth weight <2500g and <1500g,Fetal loss,Spontaneous abortion,Stillbirth,Medical termination of pregnancy.

 
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