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Labour antibiotic may shield newborns from infections

NCT ID NCT03925480

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tested whether giving mothers a single 2-gram dose of the antibiotic azithromycin during labour could reduce the risk of skin and soft tissue infections in their babies during the first three months of life. Over 2,000 pregnant women in Fiji took part, receiving either the antibiotic or a placebo. The goal was to see if this simple, one-time treatment could safely prevent common infant infections.

What this could mean

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

Active substance
azithromycin (an antibiotic)
What this could lead to
If it works, this could provide a simple, low-cost way to prevent common bacterial infections in newborns in resource-limited settings.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to other settings or populations. Antibiotic resistance is a potential long-term concern.

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

2,110 people

The number who actually took part.

Started

Jul 2019

Finished

Feb 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Pregnant women at least 18 years old intending to deliver at Colonial War Memorial Hospital (CWMH) 2. Women who have been admitted to CWMH for delivery at the time of eligibility assessment 3. Women who expect to be available, with their infant, for the duration of the study, and who agree to adhere to all protocol requirements 4. Women who will have a main place of residence within the Greater Suva area for the follow-up period and within a practical distance of the study site to allow compliance with protocol-required visits and follow-up, including attending follow-up at specified clinics 5. Women who have provided written informed consent prior to study-related procedures being performed Exclusion criteria: 1. Women who have a known macrolide allergy 2. Women who have taken antibiotics in the week prior to randomisation 3. A women who is unable or unwilling to provide informed consent for her participation in the trial or the participation of her infant 4. Women who decide prior to randomisation that they are no longer willing to participate or to have their infant participate 5. Women who have ever received, or who are anticipated to receive during the study period, any investigational agent other than the study drug 6. Women who are CWMH, Murdoch Children's Research Institute (MCRI) or study site employees who work directly with study staff, or who are working on the study 7. Women taking warfarin due to the potential for drug interactions with azithromycin 8. Women with any cardiac abnormality 9. Women taking other medications known to prolong the QT interval such as antiarrhythmics; antipsychotic agents; antidepressants; and fluoroquinolones; 10. Women with known electrolyte disturbances: including in cases of hypokalaemia and hypomagnesaemia 11. Women who will undergo general anaesthetic for delivery 12. Women carrying a foetus with intrauterine death confirmed before randomisation 13. Women carrying a foetus with a prognosis unlikely to survive 14. Women with known HIV infection and/or taking nelfinavir 15. Women who have participated in the study during a previous pregnancy 16. Women who have been admitted for management of premature labour who have unruptured membranes (This is a temporary exclusion such that the participant may be assessed for eligibility again in the same or a subsequent admission to CWMH). 17. Women with renal impairment 18. Women with hepatic impairment 19. Women with myasthenia gravis 20. Women who are taking any ergot medications

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Colonial War Memorial Hospital and Mother and Child Health Clinics

    Suva, Central, Fiji

More trials for these conditions

Other studies related to the condition(s) this trial covers.