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CTRI Number  CTRI/2025/02/080967 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 21/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of treating hidden urinary infections on Pregnancy outcomes 
Scientific Title of Study   Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-Income Countries-ABLE Trial 
Trial Acronym  ABLE 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT06723392  ClinicalTrials.gov 
Protocol version 1.1, Nov 08 2024  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Department of Physiology, KLE Academy of Higher Education and Researchs J N Medical College Nehru Nagar Belagavi and Principal Investigator Womens and Childrens Health Research Unit Wing Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9448126371  
Fax    
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Department of Physiology, KLE Academy of Higher Education and Researchs J N Medical College Nehru Nagar Belagavi and Principal Investigator Womens and Childrens Health Research Unit Wing Belagavi


KARNATAKA
590010
India 
Phone  9448126371  
Fax    
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Department of Physiology, KLE Academy of Higher Education and Researchs J N Medical College Nehru Nagar Belagavi and Principal Investigator Womens and Childrens Health Research Unit Wing Belagavi


KARNATAKA
590010
India 
Phone  9448126371  
Fax    
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     Bangladesh
Democratic Republic of the Congo
Guatemala
India
Pakistan
Zambia  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivaprasad S Goudar  Jawaharlal Nehru Medical College Belgaum  Department: Womens and Childrens Health Research Unit Institution: KLE Academy of Higher Education and Research J N Medical College, Nehru Nagar Belagavi
Belgaum
KARNATAKA 		 9448126371

sgoudar@jnmc.edu 
Dr Archana Patel  Lata Medical Research Foundation Nagpur  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 
Institutional Ethics Committee KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O239||Unspecified genitourinary tract infection in pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nitrofurantoin monohydrate / macrocrystals  Pregnant individuals with Asymptomatic Bacteriuria randomized to receive a 7-day course of oral Nitrofurantoin monohydrate / macrocrystals 100 mg twice daily (total of 14 doses)  
Comparator Agent  Placebo  Pregnant individuals with Asymptomatic Bacteriuria randomized to a receive a 7-day course of oral placebo 100 mg twice daily (total of 14 doses)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Individuals who meet the following criteria are eligible for randomization
Enrolled in Global Network Maternal Newborn Health Registry
Established pregnancy more than or equal to 12 weeks and less than or equal to 20 weeks GA by last menstrual period and/or clinical assessment and/or ultrasonography
Age: 18 years to 49 years
Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
Able to provide informed consent
Presence of a single bacterial isolate (more than 10 to the power of 5 colony forming unit (CFU)/mL) in urine at enrollment
Intent to remain in study area for at least 42 days post partum 
 
ExclusionCriteria 
Details  Individuals who meet any of the following criteria are not eligible for randomization
Gestational age less than 12 weeks or more than 20 weeks
Received treatment with any antibiotic within 14 days before screening visit
Current symptoms of UTI
History of allergy to nitrofurantoin
Pregnancy loss / miscarriage prior to randomization
Currently taking magnesium-containing antacid
Any illness / condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment
Enrollment in another trial that per the study Manual of Operation will impact this trial 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Small Vulnerable Newborn or Stillbirth defined by the occurrence of any of the following
Preterm birth,
Small for Gestational Age defined by birth weight less than 10th percentile of weight for gestational age using INTERGROWTH 21st international, sex-specific birthweight standards or Still birth, defined by fetal loss or Still birth more than 22 weeks gestation 		 Preterm birth defined by birth less than 37 completed weeks of gestation
Small for Gestational Age and Still Birth at the time of birth 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic maternal lower Urinary Tract Infection  Randomization to delivery 
Maternal pyelonephritis   Randomization to delivery 
Other serious maternal infections (at least one of intraamniotic infection, Post partum endometritis, perineal wound infection, cesarean wound infection, or sepsis)  Randomization to 42 days post-partum 
Preeclampsia  Randomization to 42 days post-partum 
Maternal ante-partum hospitalization   Randomization to 42 days post-partum 
Maternal post-partum hospitalization   Delivery to 42 days post-partum 
Maternal death   Randomization to 42 days post-partum 
Maternal Serious adverse events  Randomization to 42 days post-partum 
Gestational age at birth  At the time of birth 
Preterm birth, defined by birth less than 37 completed weeks gestation  At the time of birth 
Small for Gestational Age, defined by birth weight less than 10th percentile of weight for gestational age, using INTERGROWTH 21st international, sex-specific birthweight standards  At the time of birth 
Still birth defined by fetal loss or SB more than 22 weeks gestation  At the time of birth 
Neonatal infections (at least one of sepsis, pneumonia, or meningitis)   Birth to 42 days post-partum  
Early neonatal death   Birth to 7 days of age 
Neonatal death   Birth to 28 days of age 
Number of subsequent courses of antibiotics administered to the mother  After completion of study drug until delivery of the newborn 
 
Target Sample Size   Total Sample Size="1134"
Sample Size from India="330" 
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)   03/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/03/2027 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Through email contact to Dr Richard Derman (richardderman@gmail.com) and Dr Shivaprasad S Goudar (sgoudar@jnmc.edu)

  6. For how long will this data be available start date provided 01-04-2029 and end date provided 31-03-2034?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background: About 35 million pregnancies worldwide each year result in the birth of a small vulnerable newborn (SVN, defined by the occurrence of preterm birth [PTB] or small for gestational age [SGA]) or in stillbirth (SB). SVNs experience a higher rate of complications than those who are born at term and at a weight appropriate for gestational age. Prior studies have suggested that screening for asymptomatic bacteriuria during pregnancy and treating with antibiotics (nitrofurantoin) may reduce the incidence of low birth weight and/or prematurity, but with mixed results. This study explores the impact of treating asymptomatic bacteriuria during pregnancy in low- and middle-income countries on the incidence of SVN/SB, where the burden of SVN/SB is the highest and the potential impact of intervention is the greatest.

Primary Hypothesis: Among pregnant individuals with asymptomatic bacteriuria before 20 weeks’ gestation, the incidence of SVN/SB will be lower in pregnant individuals receiving a course of oral nitrofurantoin monohydrate/macrocrystals than among those receiving placebo.

Study Design: Parallel-arm, double-blind, placebo-controlled, 2:1 allocation, randomized controlled trial

Population: Pregnant individuals (n=1,134 total) with asymptomatic bacteriuria at initial visit during pregnancy, who enroll in the Maternal Newborn Health Registry and are followed through delivery at study hospitals, birthing facilities or home, in 7 sites (Bangladesh, India [2 sites], Pakistan, Democratic Republic of Congo, Zambia and Guatemala).

Treatment Arms:

Intervention: 7-day course of oral nitrofurantoin monohydrate/macrocrystals

Comparison: 7-day course of oral identical-appearing placebo

Primary Endpoint:

a. SVN/SB, defined by the occurrence of any of the following:

b. PTB, defined by birth <37 completed weeks gestation;

c. SGA, defined by birth weight <10th percentile of weight for gestational age, using INTERGROWTH 21st international, sex-specific birthweight standards; or

d. SB, defined by fetal loss or SB > 22 weeks’ gestation.

Secondary Endpoints:

Maternal

1. Clinical endpoints

a. Symptomatic maternal lower urinary tract infection (randomization to delivery)

b. Maternal pyelonephritis (randomization to delivery)

c. Other serious maternal infections (at least one of intraamniotic infection, post-partum (PP) endometritis, perineal wound infection, cesarean wound infection, or sepsis) (randomization to 42 days PP)

d. Preeclampsia (randomization to 42 days PP)

e. Maternal antepartum (AP) hospitalization (randomization to 42 days PP)

f. Maternal PP hospitalization (delivery to 42 days PP)

g. Maternal death (randomization to 42 days PP)

     2. Safety endpoints

     a. Serious adverse events (randomization to 42 days PP)

Neonatal

1. Clinical endpoints

a. Gestational age at birth

b. PTB, defined by birth <37 completed weeks gestation

c. SGA, defined by birth weight <10th percentile of weight for gestational age, using INTERGROWTH 21st international, sex-specific birthweight standards

d. SB, defined by fetal loss or SB > 22 weeks’ gestation

e. Neonatal infections (at least one of sepsis, pneumonia, or meningitis) (birth to 42 days PP)

f. Early neonatal death (birth to 7 days of age)

g. Neonatal death (birth to 28 days of age)

 
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