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Could a simple antibiotic during pregnancy save thousands of newborns?

NCT ID NCT06723392

Disease control Sponsor: NICHD Global Network for Women's and Children's Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether treating asymptomatic bacteriuria (a bladder infection with no symptoms) in pregnant women can reduce the number of preterm births, stillbirths, and underweight babies. Over 1,100 pregnant women in seven low- and middle-income countries will receive either a 7-day course of the antibiotic nitrofurantoin or a placebo. The goal is to see if this simple, low-cost intervention improves newborn survival and health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nitrofurantoin (an antibiotic)
What this could lead to
If it works, this could show that treating hidden bladder infections during pregnancy reduces the risk of preterm birth, stillbirth, and underweight babies in low-resource settings.
What could go wrong
This is a large phase 3 trial, but previous studies on this topic have had mixed results. The antibiotic may not improve outcomes, and side effects or antibiotic resistance are possible risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,134 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 49 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Individuals who meet the following criteria are eligible for randomization: * Enrolled in GN MNHR * Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and/or clinical assessment and/or ultrasonography * Age: 18 years (or lower limit age eligible\*) to 49 years \* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations. * 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 (\>105 colony forming unit (CFU)/mL) in urine at enrollment * Intent to remain in study area for at least 42 days PP Exclusion Criteria: Individuals who meet any of the following criteria are not eligible for randomization: * Gestational age \<12 weeks or \>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 MOP will impact this trial

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Conditions

The condition(s) this trial relates to.

bacteriuria fetal growth restriction pregnancy disorder with abortive outcome Premature Birth Stillbirth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacteriuria (asymptomatic) in pregnancy Preterm birth Small for gestational age (SGA) Stillbirth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aga Khan University

    NOT_YET_RECRUITING

    Karachi, Pakistan, Pakistan

  • Icddr,B

    RECRUITING

    Dhaka, Bangladesh, Bangladesh

  • Institue for Nutrition of Central America and Panama (INCAP)

    NOT_YET_RECRUITING

    Guatemala City, Departamento de Guatemala, Guatemala

  • KLE Academy of Higher Education and Research

    RECRUITING

    Belagavi, Karnataka, India

  • Kinshasa School of Public Health

    NOT_YET_RECRUITING

    Kinshasa, DRC, Democratic Republic of the Congo

  • Lata Medical Research Foundation

    NOT_YET_RECRUITING

    Nagpur, Maharashtra, India

  • University Teaching Hospital

    NOT_YET_RECRUITING

    Lusaka, Zambia, Zambia

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