Preterm Prelabor Rupture of MembranesPhase 4NCT07669207
Extended Azithromycin Treatment in Prelabor Rupture of Membranes
A Phase 4 study testing Azithromycin (Azithro) and Standard Azithromycin Dosing in people with Preterm Prelabor Rupture of Membranes and PPROM, run by Alexa Henderson at 1 site in United States.
Trial summary
The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Prelabor Rupture of Membranes, PPROM
- What is being tested?
- Azithromycin (Azithro) and Standard Azithromycin Dosing
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2026to Jul 2028
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton gestation
- Gestational age at time of PPROM between 22w0d and 28w0d
- Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)
- Remain pregnant 48 hours after presentation.
- Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included.
- Pregnant patients below the age of 18 are eligible.
Who cannot join
- Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)
- Lethal congenital defects
- Multiple gestation
- Ongoing alternative antibiotic treatment
- Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic
- History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
Show all 15Show fewer
- Known prolongation of QT interval
- History of torsades de pointes
- Congenital long QT syndrome
- Bradyarrhythmia
- Decompensated heart failure
- Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents
- Impaired hepatic function
- GFR<10 mL/min
- Diagnosis of myasthenia gravis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christina Megli, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15217
Alexa Henderson, MD, 9136019107, hendersona8@upmc.edu
Christina Megli, MD, PhD, meglicj@upmc.edu
About this study
Official title: Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study
The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.
Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.
Participants will:
- Be randomly assigned to one of two groups:
- The standard antibiotic treatment
- The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.
- Participants will be asked to complete a survey regarding their experience and side effects.
Read the detailed description
Multiple randomized trials have shown that antibiotic treatment for preterm prelabor rupture of membranes (PPROM) increases pregnancy latency and decreases maternal and neonatal morbidity. However, the optimal dosing schedule for azithromycin in PPROM is not fully understood. This pilot study will assess the feasibility of a non-blinded, randomized-controlled trial comparing maternal and neonatal outcomes between the standard PPROM antibiotic regimen and the standard regimen with extended azithromycin therapy in participants with periviable and extremely preterm PPROM between 22- and 28-weeks gestational age. Preliminary data on pregnancy latency, maternal morbidity, and neonatal outcomes will also be collected. Findings from this feasibility study will inform the design of a future, powered study.
The investigators hypothesize that extended azithromycin therapy may be associated with longer pregnancy latency and decreased rates of maternal and neonatal morbidity compared to standard therapy. This hypothesis is exploratory, and the present feasibility study is not powered to test a hypothesis.
The primary objective is to evaluate the feasibility of conducting a non-blinded, randomized controlled trial of extended azithromycin therapy in participants with periviable and extremely preterm prelabor rupture of membranes (PPROM) who desire expectant management between 22 and 28 weeks gestational age. Specifically, we aim to assess feasibility metrics including recruitment and consent rates, randomization procedures, adherence to the study protocol, and completeness of follow-up.
The secondary objectives of this pilot study are to estimate the variability (standard deviation) of pregnancy latency in this population to inform sample-size calculations for a future definitive trial. The investigators will also collect preliminary data on maternal outcomes (e.g., rates of intra-amniotic infection, endometritis, and placental abruption) and neonatal outcomes (gestational age at delivery, NICU admission, morbidity) for planning purposes. Additionally, the investigators will review placental pathology reports to identify the stage/grade of chorioamnionitis per the Amsterdam criteria. The investigators will obtain an initial estimate of the effect of extended azithromycin on pregnancy latency, recognizing that this pilot study is not powered to detect clinically meaningful differences.
- Conditions
- Preterm Prelabor Rupture of Membranes, PPROM
- Being tested
- Azithromycin (Azithro), Standard Azithromycin Dosing
- Keywords
- azithromycin, peri-viability
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin (Azithro)Drug
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.
Standard Azithromycin DosingDrug
Oral Azithromycin 1g once.
| Study group | Role | What they receive |
|---|---|---|
| Standard Antibiotic Regimen | Active comparator | A single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days. Receives: Drug: Standard Azithromycin Dosing |
| Extended Azithromycin Regimen | Experimental | The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses. Receives: Drug: Azithromycin (Azithro); Drug: Standard Azithromycin Dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Capability
Number of participants recruited per week/month
Measured: From recruitment to enrollment, up to 3 days.
Participant Eligibility
Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility
Measured: From recruitment until enrollment, up to 3 days.
Retention and Dropout Rates
Percentage of patients who complete study and reasons for withdrawal from study.
Measured: From recruitment to completion of the study, up to 4 months.
Intervention Delivery
Percentage of interventions delivered as intended
Measured: From recruitment to completion of intervention, up to 15 days.
Participant Acceptability
Likert-scale survey evaluating the participant's perceived affective attitude, burden, ethicality, intervention coherence, confidence, opportunity costs, general acceptability, and side effects related to the study.
Measured: At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
Data Collection Procedures
Data completeness measured as number of participants with complete data entry.
Measured: From recruitment to completion of postpartum period, up to 6 months.
Resource Use and Cost
Total cost versus planned budget, time and staffing required.
Measured: From recruitment to postpartum period, up to 6 months.
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Adverse events associated with antibiotic usage, maternal and neonatal outcomes, bacterial resistance profiles. Assessed using previously validated Medication Side Effect survey.
Measured: Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
Protocol Deviations
Incidence of protocol deviation, indications for protocol deviation.
Measured: From recruitment to completion of intervention, up to 15 days.
Time for Delivery
Amount of study team time needed for delivery.
Measured: From recruitment to completion of postpartum period, up to 6 months.
Financial Resources
Amount of monetary resources needed for study delivery.
Measured: From recruitment to postpartum period, up to 6 months.
Secondary outcomes (24)
Pregnancy Latency
Number of days participants remain pregnant after PPROM until delivery
Measured: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Pregnancy Outcome
Intrauterine fetal demise, neonatal demise while in NICU, living infant to NICU discharge.
Measured: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
NICU Admission
Requirement for NICU admission.
Measured: From day of delivery through neonatal discharge, up to 4 months.
Neonatal Ventilatory Support
Level of ventilatory support required for neonate (none, bubble CPAP, intubation).
Measured: From day of delivery through neonatal discharge, up to 4 months.
Neonatal Sepsis
Rates of early-onset sepsis, late-onset sepsis (including culture positive sepsis and culture-negative, clinically suspected sepsis)
Measured: From day of delivery through neonatal discharge, up to 4 months.
Neonatal Intraventricular Hemorrhage (IVH)
Grade of IVH if present.
Measured: From day of delivery through neonatal discharge, up to 4 months.
Neonatal respiratory distress syndrome
Documented respiratory distress syndrome by neonatology providers.
Measured: From day of delivery through neonatal discharge, up to 4 months.
Necrotizing enterocolitis
Rate of documented necrotizing enterocolitis by neonatology team.
Measured: From day of delivery through neonatal discharge, up to 4 months.
Mode of delivery
Cesarean section, vaginal delivery, or operative delivery.
Measured: From day of PPROM (D0) through day of delivery, up to 3 months.
Indication for delivery
Non-reassuring fetal status, labor, intra-uterine infection, placental abruption, cord prolapse.
Measured: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal group B streptococcus status
Positive or negative group B streptococcus maternal rectovaginal culture.
Measured: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal postpartum hemorrhage
Estimated blood loss greater than 1000mL after delivery.
Measured: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Suspected intraamniotic infection
Defined as maternal temperature greater than 39 degrees Celsius OR maternal temperature between 38.0-38.9 degrees Celsius plus one or more additional clinical risk factors: maternal leukocytosis greater than 15,000/mm^3, purulent cervical drainage, or fetal tachycardia.
Measured: From day of PPROM (D0) through day of delivery, up to 3 months.
Confirmed intraamniotic infection
Positive amniotic fluid test result OR placental pathology demonstrating histologic evidence of infection or inflammation.
Measured: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Maternal sepsis
Suspected sepsis documented by clinical provider in chart or culture proven sepsis.
Measured: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal placental abruption
Clinical evidence of placental abruption documented by OBGYN provider.
Measured: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal ICU Admission
Required admission to adult ICU prior to or after delivery.
Measured: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal postpartum endomtritis
Documented clinical diagnosis of endometritis in participant chart.
Measured: From day of delivery through 6 weeks postpartum.
Maternal retained products of conception
Clinical documentation of retained products of conception in participant chart.
Measured: From day of delivery through 6 weeks postpartum.
Additional maternal surgical procedures
Requirement of additional surgical procedures following delivery (suction dilation and curettage, hysterectomy).
Measured: From day of delivery through 6 weeks postpartum.
Maternal blood transfusion
Documented maternal blood transfusion following delivery.
Measured: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal antibiotic course completion
Number of participants in intervention arm who completed the extended antibiotic course.
Measured: From day of PPROM (D0) through day of delivery, up to D14.
Additional maternal antibiotic administration
Maternal antibiotics administered for other indications after enrollment in the study.
Measured: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal placental pathology
Maternal and fetal inflammation stage/grade as defined by the Amsterdam Criteria.
Measured: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start19 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Prelabor 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexa Henderson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexa Henderson, University of Pittsburgh
- Investigators
- Christina Megli, MD/PhD, Principal investigator, University of Pittsburgh Magee-Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669207
- Sponsor's protocol ID
- STUDY25110085
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the study will potentially be shared with future collaborating sites if the feasibility trial is expanded to a multi-center trial.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study
- ClinicalTrials.gov ID
- NCT07669207
- Acronym / sponsor ID
- STUDY25110085
- Conditions
- Preterm Prelabor Rupture of Membranes, PPROM
- Keywords
- azithromycin, peri-viability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexa HendersonUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Jun 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.
The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.
Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.
Participants will:
- Be randomly assigned to one of two groups:
- The standard antibiotic treatment
- The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.
- Participants will be asked to complete a survey regarding their experience and side effects.
Detailed description
Multiple randomized trials have shown that antibiotic treatment for preterm prelabor rupture of membranes (PPROM) increases pregnancy latency and decreases maternal and neonatal morbidity. However, the optimal dosing schedule for azithromycin in PPROM is not fully understood. This pilot study will assess the feasibility of a non-blinded, randomized-controlled trial comparing maternal and neonatal outcomes between the standard PPROM antibiotic regimen and the standard regimen with extended azithromycin therapy in participants with periviable and extremely preterm PPROM between 22- and 28-weeks gestational age. Preliminary data on pregnancy latency, maternal morbidity, and neonatal outcomes will also be collected. Findings from this feasibility study will inform the design of a future, powered study.
The investigators hypothesize that extended azithromycin therapy may be associated with longer pregnancy latency and decreased rates of maternal and neonatal morbidity compared to standard therapy. This hypothesis is exploratory, and the present feasibility study is not powered to test a hypothesis.
The primary objective is to evaluate the feasibility of conducting a non-blinded, randomized controlled trial of extended azithromycin therapy in participants with periviable and extremely preterm prelabor rupture of membranes (PPROM) who desire expectant management between 22 and 28 weeks gestational age. Specifically, we aim to assess feasibility metrics including recruitment and consent rates, randomization procedures, adherence to the study protocol, and completeness of follow-up.
The secondary objectives of this pilot study are to estimate the variability (standard deviation) of pregnancy latency in this population to inform sample-size calculations for a future definitive trial. The investigators will also collect preliminary data on maternal outcomes (e.g., rates of intra-amniotic infection, endometritis, and placental abruption) and neonatal outcomes (gestational age at delivery, NICU admission, morbidity) for planning purposes. Additionally, the investigators will review placental pathology reports to identify the stage/grade of chorioamnionitis per the Amsterdam criteria. The investigators will obtain an initial estimate of the effect of extended azithromycin on pregnancy latency, recognizing that this pilot study is not powered to detect clinically meaningful differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Antibiotic Regimen | Active comparator | Drug: Standard Azithromycin DosingA single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days. |
| Extended Azithromycin Regimen | Experimental | Drug: Azithromycin (Azithro), Drug: Standard Azithromycin DosingThe standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Singleton gestation
- Gestational age at time of PPROM between 22w0d and 28w0d
- Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)
- Remain pregnant 48 hours after presentation.
- Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included.
Key exclusion criteria (15 listed)
- Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)
- Lethal congenital defects
- Multiple gestation
- Ongoing alternative antibiotic treatment
- Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic
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 |
|---|---|---|
| Azithromycin (Azithro)Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen. | Drug | Extended Azithromycin Regimen |
| Standard Azithromycin DosingOral Azithromycin 1g once. | Drug | Extended Azithromycin Regimen, Standard Antibiotic Regimen |
Primary outcome
Recruitment Capability
Time frame: From recruitment to enrollment, up to 3 days.
Number of participants recruited per week/month
Participant Eligibility
Time frame: From recruitment until enrollment, up to 3 days.
Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility
Retention and Dropout Rates
Time frame: From recruitment to completion of the study, up to 4 months.
Percentage of patients who complete study and reasons for withdrawal from study.
Intervention Delivery
Time frame: From recruitment to completion of intervention, up to 15 days.
Percentage of interventions delivered as intended
Participant Acceptability
Time frame: At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
Likert-scale survey evaluating the participant's perceived affective attitude, burden, ethicality, intervention coherence, confidence, opportunity costs, general acceptability, and side effects related to the study.
Data Collection Procedures
Time frame: From recruitment to completion of postpartum period, up to 6 months.
Data completeness measured as number of participants with complete data entry.
Resource Use and Cost
Time frame: From recruitment to postpartum period, up to 6 months.
Total cost versus planned budget, time and staffing required.
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Time frame: Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
Adverse events associated with antibiotic usage, maternal and neonatal outcomes, bacterial resistance profiles. Assessed using previously validated Medication Side Effect survey.
Protocol Deviations
Time frame: From recruitment to completion of intervention, up to 15 days.
Incidence of protocol deviation, indications for protocol deviation.
Time for Delivery
Time frame: From recruitment to completion of postpartum period, up to 6 months.
Amount of study team time needed for delivery.
Financial Resources
Time frame: From recruitment to postpartum period, up to 6 months.
Amount of monetary resources needed for study delivery.
24 secondary outcomes
Pregnancy Latency
Time frame: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Pregnancy Outcome
Time frame: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
NICU Admission
Time frame: From day of delivery through neonatal discharge, up to 4 months.
Neonatal Ventilatory Support
Time frame: From day of delivery through neonatal discharge, up to 4 months.
Neonatal Sepsis
Time frame: From day of delivery through neonatal discharge, up to 4 months.
Neonatal Intraventricular Hemorrhage (IVH)
Time frame: From day of delivery through neonatal discharge, up to 4 months.
Neonatal respiratory distress syndrome
Time frame: From day of delivery through neonatal discharge, up to 4 months.
Necrotizing enterocolitis
Time frame: From day of delivery through neonatal discharge, up to 4 months.
Mode of delivery
Time frame: From day of PPROM (D0) through day of delivery, up to 3 months.
Indication for delivery
Time frame: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal group B streptococcus status
Time frame: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal postpartum hemorrhage
Time frame: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Suspected intraamniotic infection
Time frame: From day of PPROM (D0) through day of delivery, up to 3 months.
Confirmed intraamniotic infection
Time frame: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Maternal sepsis
Time frame: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal placental abruption
Time frame: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal ICU Admission
Time frame: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal postpartum endomtritis
Time frame: From day of delivery through 6 weeks postpartum.
Maternal retained products of conception
Time frame: From day of delivery through 6 weeks postpartum.
Additional maternal surgical procedures
Time frame: From day of delivery through 6 weeks postpartum.
Maternal blood transfusion
Time frame: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal antibiotic course completion
Time frame: From day of PPROM (D0) through day of delivery, up to D14.
Additional maternal antibiotic administration
Time frame: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal placental pathology
Time frame: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
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 4 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the study will potentially be shared with future collaborating sites if the feasibility trial is expanded to a multi-center trial.
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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.
Christina Megli, MD, PhD contact
Christina Megli, MD/PhD principal investigator
University of Pittsburgh Magee-Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin (Azithro) and Standard Azithromycin Dosing in people with Preterm Prelabor Rupture of Membranes and PPROM, run by Alexa Henderson at 1 site in United States.
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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 United States. 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 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?
Contact Alexa Henderson, MD (9136019107, hendersona8@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Capability (time frame: From recruitment to enrollment, up to 3 days.). The study lists 11 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 4 Sep 2026.