Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,134

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

November 30, 2028

Conditions
Preterm BirthSmall for Gestational Age (SGA)StillbirthBacteriuria (Asymptomatic) in Pregnancy
Interventions
DRUG

Oral nitrofurantoin monohydrate/macrocrystals

7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)

OTHER

Placebo

7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Trial Locations (7)

Unknown

Icddr,B, Dhaka

Kinshasa School of Public Health, Kinshasa

Institue for Nutrition of Central America and Panama (INCAP), Guatemala City

KLE Academy of Higher Education and Research, Belagavi

Lata Medical Research Foundation, Nagpur

Aga Khan University, Karachi

University Teaching Hospital, Lusaka

All Listed Sponsors
collaborator

RTI International

OTHER

collaborator

University of Virginia

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

Thomas Jefferson University

OTHER

collaborator

Columbia University

OTHER

collaborator

Boston University

OTHER

collaborator

University of Colorado, Denver

OTHER

collaborator

University of North Carolina, Chapel Hill

OTHER

collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

collaborator

Kinshasa School of Public Health

OTHER

collaborator

Institute of Nutrition of Central America and Panama

OTHER

collaborator

Lata Medical Research Foundation, Nagpur

OTHER

collaborator

Aga Khan University

OTHER

collaborator

University Teaching Hospital, Lusaka, Zambia

OTHER

collaborator

KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India

UNKNOWN

lead

NICHD Global Network for Women's and Children's Health

NETWORK