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

Sponsor
NICHD Global Network for Women's and Children's Health
Study ID
NCT06723392
Phase
PHASE3
Status
Recruiting
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Conditions

  • Bacteriuria (Asymptomatic) in Pregnancy
  • Preterm Birth
  • Small for Gestational Age (SGA)
  • Stillbirth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Oral nitrofurantoin monohydrate/macrocrystals — DRUG
    7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
  • Placebo — OTHER
    7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Study Details

This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \[End preventable deaths of newborns and children under 5 years of age\] by examining the potential impact of this practice to reduce the incidence of SVN/SB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).

Key Dates

First listed
Dec 9, 2024
Start date
Dec 8, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
1,134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral nitrofurantoin monohydrate/macrocrystals
    Pregnant individuals with AB randomized to receive a 7-day course of oral NM/M 100 mg twice daily (total of 14 doses)
  • Placebo Comparator: Placebo
    Pregnant individuals with AB randomized to a receive a 7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Primary Outcome Measure

Number of small vulnerable newborn (SVN) or stillbirth (SB) [ Time Frame: From Pregnancy until 42 days postpartum ]

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