Pre-term Premature Rupture of MembranesPhase 1NCT07394725
Unlocking New Avenues: Azithromycin Vs Erythromycin in Pre-term, Pre-mature Rupture of Membrane Management
A Phase 1 study testing Erythromycin and Azithromycin in people with Pre-term Premature Rupture of Membranes, run by District Headquarters Teaching Hospital Sahiwal at 1 site in Pakistan.
Trial summary
This randomized controlled trial at Sahiwal Teaching Hospital (April 2024-March 2025) compared azithromycin and erythromycin for managing preterm premature rupture of membranes (PPROM) in 250 women (28-33+6 weeks gestation). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pre-term Premature Rupture of Membranes
- What is being tested?
- Erythromycin and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- Aged 18 to 40 years
- Singleton pregnancy with PPROM and
- 28 weeks 0 days to 33 weeks 6 days of gestation.
Who cannot join
- Pregnancy was before 28 weeks
- Possible fetal defects
- Signs of active labor
- Major vaginal bleeding
- Signs of chorioamnionitis on arrival
- Placenta previa or placental abruption
- Allergic to macrolide antibiotics or received antibiotic treatment less than five days earlier were all excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sahiwal Teaching Hospital , Sahiwal
Sāhīwāl, Punjab Province, 57000
About this study
This randomized controlled trial at Sahiwal Teaching Hospital (April 2024-March 2025) compared azithromycin and erythromycin for managing preterm premature rupture of membranes (PPROM) in 250 women (28-33+6 weeks gestation). Participants received either azithromycin 500 mg once daily or erythromycin 250 mg every six hours for seven days.
Read the detailed description
Background: Preterm premature rupture of membranes (PPROM) is a significant contributor to preterm births and neonatal morbidity worldwide. While erythromycin has traditionally been used for this purpose, limitations related to tolerability and dosing frequency have prompted the evaluation of alternative agents such as azithromycin.
Objective: To compare the clinical efficacy of azithromycin versus erythromycin in the management of PPROM, focusing on latency period, maternal infection rates, neonatal outcomes, and overall drug tolerability.
Methodology: This randomized controlled trial was conducted at Sahiwal Teaching Hospital from 01-04-2024 to 31-03-2025. A total of 250 pregnant women with confirmed PPROM between 28+0 and 33+6 weeks of gestation were randomly allocated into two groups: Group A oral dose of azithromycin 500mg once daily for seven days, while Group B received erythromycin 250 mg orally every six hours for seven days. Primary outcomes included latency period, incidence of chorioamnionitis, mode of delivery, and key neonatal indicators such as APGAR scores, NICU admission rates, respiratory distress syndrome (RDS), and neonatal mortality.
- Conditions
- Pre-term Premature Rupture of Membranes
- Being tested
- Erythromycin, Azithromycin
- Keywords
- Azithromycin, Erythromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Erythromycin 250 mg orally every 6 hours for 7 consecutive days.
AzithromycinDrug
Azithromycin 500 mg orally once daily for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin Group | Experimental | Participants will receive oral azithromycin as per protocol. Receives: Drug: Azithromycin |
| Erythromycin Group | Experimental | Participants will receive oral erythromycin as per protocol. Receives: Drug: Erythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Outcome
Primary Outcome Measure 1
Name: Incidence of Clinical Chorioamnionitis
Description:
Clinical chorioamnionitis will be diagnosed based on predefined clinical criteria including maternal fever (≥38°C), maternal tachycardia, uterine tenderness, and foul-smelling amniotic fluid, supported by laboratory evidence of infection.
Measurement Tool:
Daily standardized clinical assessment and laboratory evaluation.
Time Frame:
Within 7 days of enrollment or until delivery, whichever occurs earlier.
Unit of Measure:
Number of participants diagnosed with clinical chorioamnionitis.
Primary Outcome Measure 2
Name: Maternal Laboratory Evidence of Infection
Description:
Maternal inflammatory response will be assessed using total leukocyte count (TLC) and C-reactive protein (CRP) levels to support the diagnosis of infection.
Measurement Tool:
Venous blood sampling for TLC and CRP.
Time Frame:
Measured on alternate days until delivery
Measured: 07 Days
Neonatal Outcomes
Primary Outcome Measure 3
Name: Neonatal Birth Weight
Description:
Neonatal birth weight measured immediately after delivery.
Measurement Tool:
Calibrated digital weighing scale.
Time Frame:
At birth.
Unit of Measure:
Grams.
Primary Outcome Measure 4
Name: APGAR Score at 1 Minute
Description:
Assessment of neonatal APGAR score at 1 minute after birth.
Measurement Tool:
Standard APGAR scoring system.
Time Frame:
1 minute after birth.
Unit of Measure:
Score (0-10).
Measured: 07 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Apr 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-term Premature Rupture of MembranesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- District Headquarters Teaching Hospital Sahiwal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahpara Shaukat, District Headquarters Teaching Hospital Sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394725
- Sponsor's protocol ID
- 130/IRV/SLMC/SWL
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared due to institutional policies and concerns regarding participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unlocking New Avenues: Azithromycin Vs Erythromycin in Pre-term, Pre-mature Rupture of Membrane Management
- ClinicalTrials.gov ID
- NCT07394725
- Acronym / sponsor ID
- 130/IRV/SLMC/SWL
- Conditions
- Pre-term Premature Rupture of Membranes
- Keywords
- Azithromycin, Erythromycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- District Headquarters Teaching Hospital SahiwalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 6 Feb 2026 (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.
This randomized controlled trial at Sahiwal Teaching Hospital (April 2024-March 2025) compared azithromycin and erythromycin for managing preterm premature rupture of membranes (PPROM) in 250 women (28-33+6 weeks gestation). Participants received either azithromycin 500 mg once daily or erythromycin 250 mg every six hours for seven days.
Detailed description
Background: Preterm premature rupture of membranes (PPROM) is a significant contributor to preterm births and neonatal morbidity worldwide. While erythromycin has traditionally been used for this purpose, limitations related to tolerability and dosing frequency have prompted the evaluation of alternative agents such as azithromycin.
Objective: To compare the clinical efficacy of azithromycin versus erythromycin in the management of PPROM, focusing on latency period, maternal infection rates, neonatal outcomes, and overall drug tolerability.
Methodology: This randomized controlled trial was conducted at Sahiwal Teaching Hospital from 01-04-2024 to 31-03-2025. A total of 250 pregnant women with confirmed PPROM between 28+0 and 33+6 weeks of gestation were randomly allocated into two groups: Group A oral dose of azithromycin 500mg once daily for seven days, while Group B received erythromycin 250 mg orally every six hours for seven days. Primary outcomes included latency period, incidence of chorioamnionitis, mode of delivery, and key neonatal indicators such as APGAR scores, NICU admission rates, respiratory distress syndrome (RDS), and neonatal mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin Group | Experimental | Drug: AzithromycinParticipants will receive oral azithromycin as per protocol. |
| Erythromycin Group | Experimental | Drug: ErythromycinParticipants will receive oral erythromycin as per protocol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women
- Aged 18 to 40 years
- Singleton pregnancy with PPROM and
- 28 weeks 0 days to 33 weeks 6 days of gestation.
Key exclusion criteria (7 listed)
- Pregnancy was before 28 weeks
- Possible fetal defects
- Signs of active labor
- Major vaginal bleeding
- Signs of chorioamnionitis on arrival
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 |
|---|---|---|
| ErythromycinErythromycin 250 mg orally every 6 hours for 7 consecutive days. | Drug | Erythromycin Group |
| AzithromycinAzithromycin 500 mg orally once daily for 7 consecutive days | Drug | Azithromycin Group |
Primary outcome
Maternal Outcome
Time frame: 07 Days
Primary Outcome Measure 1 Name: Incidence of Clinical Chorioamnionitis Description: Clinical chorioamnionitis will be diagnosed based on predefined clinical criteria including maternal fever (≥38°C), maternal tachycardia, uterine tenderness, and foul-smelling amniotic fluid, supported by laboratory evidence of infection. Measurement Tool: Daily standardized clinical assessment and laboratory evaluation. Time Frame: Within 7 days of enrollment or until delivery, whichever occurs earlier. Unit of Measure: Number of participants diagnosed with clinical chorioamnionitis. Primary Outcome Measure 2 Name: Maternal Laboratory Evidence of Infection Description: Maternal inflammatory response will be assessed using total leukocyte count (TLC) and C-reactive protein (CRP) levels to support the diagnosis of infection. Measurement Tool: Venous blood sampling for TLC and CRP. Time Frame: Measured on alternate days until delivery
Neonatal Outcomes
Time frame: 07 days
Primary Outcome Measure 3 Name: Neonatal Birth Weight Description: Neonatal birth weight measured immediately after delivery. Measurement Tool: Calibrated digital weighing scale. Time Frame: At birth. Unit of Measure: Grams. Primary Outcome Measure 4 Name: APGAR Score at 1 Minute Description: Assessment of neonatal APGAR score at 1 minute after birth. Measurement Tool: Standard APGAR scoring system. Time Frame: 1 minute after birth. Unit of Measure: Score (0-10).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared due to institutional policies and concerns regarding participant confidentiality.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erythromycin and Azithromycin in people with Pre-term Premature Rupture of Membranes, run by District Headquarters Teaching Hospital Sahiwal at 1 site in 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Outcome (time frame: 07 Days). The study lists 2 primary outcomes in all. 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 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.