Maternal and Neonatal SepsisPhase 4NCT06958146
Azithromycin for Preventing Maternal and Neonatal Infections During Labor.
A Phase 4 study testing oral azithromycin and no azithromycin in people with Maternal and Neonatal Sepsis and Intrapartum Antibiotics, run by Armed Forces Hospital, Pakistan.
Trial summary
In this study, we want to see the role of the antibiotic, azithromycin, in preventing maternal and neonatal infections, if the drug is given intrapartum to the mother Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Maternal and Neonatal Sepsis, Intrapartum Antibiotics
- What is being tested?
- oral azithromycin and no azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant ladies with no risk factors for sepsis who go into spontaneous labor or induced labor
Who cannot join
- pregnant with risk factors for sepsis like maternal fever , raised WBC count, chorioamnionitis, or having. history of any adverse even with macrolides
About this study
Official title: Impact of Single Dose Azithromycin During Labor on Maternal and Neonatal Infections
In this study, we want to see the role of the antibiotic, azithromycin, in preventing maternal and neonatal infections, if the drug is given intrapartum to the mother
- Being tested
- oral azithromycin, no azithromycin
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral azithromycinDrug
we will be administering single-dose oral azithromycin to ladies who go into labor and have no risk factors for sepsis, as there is increased risk of postpartum sepsis in both mother and neonate after normal vaginal delivery in low-income and middle-income countries
no azithromycinOther
participants in this arm will be given only standard labor care and no oral azithromycin
| Study group | Role | What they receive |
|---|---|---|
| pregnanct ladies in labor receiving single dose azithromycin along with standard labor care | Experimental | The participants in this arm will receive a single dose of 2 g oral azithromycin along with standard care in the intrapartum period Receives: Drug: oral azithromycin |
| Pregnant ladies in labor receiving only standard care and no oral azithromycin | Placebo comparator | participants in this arm will be given only standard labor care and no antibiotics Receives: Other: no azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal infections
Measured: birth to 6 weeks post partum
Secondary outcomes (1)
neonatal infections
Measured: birth to 6 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal and Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, arshad khushdil, Armed Forces Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958146
- Sponsor's protocol ID
- Azithromycin 2025
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will upload the data on the website on clinicaltrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Single Dose Azithromycin During Labor on Maternal and Neonatal Infections
- ClinicalTrials.gov ID
- NCT06958146
- Acronym / sponsor ID
- Azithromycin 2025
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Armed Forces Hospital, PakistanUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we want to see the role of the antibiotic, azithromycin, in preventing maternal and neonatal infections, if the drug is given intrapartum to the mother
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnanct ladies in labor receiving single dose azithromycin along with standard labor care | Experimental | Drug: oral azithromycinThe participants in this arm will receive a single dose of 2 g oral azithromycin along with standard care in the intrapartum period |
| Pregnant ladies in labor receiving only standard care and no oral azithromycin | Placebo comparator | Other: no azithromycinparticipants in this arm will be given only standard labor care and no antibiotics |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant ladies with no risk factors for sepsis who go into spontaneous labor or induced labor
Key exclusion criteria (1 listed)
- pregnant with risk factors for sepsis like maternal fever , raised WBC count, chorioamnionitis, or having. history of any adverse even with macrolides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral azithromycinwe will be administering single-dose oral azithromycin to ladies who go into labor and have no risk factors for sepsis, as there is increased risk of postpartum sepsis in both mother and neonate after normal vaginal delivery in low-income and middle-income countries | Drug | pregnanct ladies in labor receiving single dose azithromycin along with standard labor care |
| no azithromycinparticipants in this arm will be given only standard labor care and no oral azithromycin | Other | Pregnant ladies in labor receiving only standard care and no oral azithromycin |
Primary outcome
maternal infections
Time frame: birth to 6 weeks post partum
1 secondary outcome
neonatal infections
Time frame: birth to 6 weeks post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Yes. we will upload the data on the website on clinicaltrials.gov
Related trials for Maternal and Neonatal Sepsis
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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruitingPhase 4
PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
Rupture of Membranes Prior to Onset of Labor
RecruitingObservational study
Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations
Early-Onset Neonatal Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral azithromycin and no azithromycin in people with Maternal and Neonatal Sepsis and Intrapartum Antibiotics, run by Armed Forces Hospital, Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal infections (time frame: birth to 6 weeks post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.