Treatment of ppROM With Erythromycin vs. Azithromycin Trial (NCT03060473) | Clinical Trial Compass
TerminatedPhase 3
Treatment of ppROM With Erythromycin vs. Azithromycin Trial
Stopped: Patient population that meets study criteria is insufficient to continue project in a reasonable amount of time. To continue is futile in resources, staff time, and effort.
United States21 participantsStarted 2017-02-23
Plain-language summary
Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This pregnancy complication is a major contributor to preterm births and results in neonatal morbidity and mortality. The current standard of care for PPROM subjects between the gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do not tolerate this regimen over the course of 7 days. In addition, there is a national shortage of erythromycin, and published expert opinion proposed to use a second-generation macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The investigators' working hypothesis is that there is no measurable difference in the primary outcome between the group randomized to the azithromycin regimen versus the group randomized to the erythromycin regimen.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Maternal age ≥ 18 years and \<50 years
* Pregnant women between the gestational age 23 6/7 and 32 6/7 weeks
* Singleton pregnancy
* Preterm premature rupture of membranes, determined clinically
* Cervical dilation visually ≤ 5cm on sterile speculum exam.
* Planned delivery at John Sealy Hospital (JSH)
Exclusion Criteria:
* Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)
* Any contraindication to expectant management (e.g. fetal compromise, chorioamnionitis, placental abruption)
* Cervical cerclage in place
* Placenta previa or other known placental anomalies
* Contraindication to any of the antibiotics used (allergy to macrolides).
* Enrolled in another trial that may affect outcome.
* Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention.
* No prenatal care (less than 2 prenatal visits)
* Non-resident subject who is unlikely to be followed-up after delivery
* Any fetal congenital anomaly.
* Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal
* Significant renal disease defined as serum creatinine known to be \>2.0 mg/dl or on dialysis.
* Active congestive heart failure (EF\<45%) or pulmonary edema.
* Immunosuppressed subjects: i.e., taking systemic immunosuppressants or ster…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Women Still Pregnant by Day 7
Timeframe: 7 days
Trial details
NCT IDNCT03060473
SponsorThe University of Texas Medical Branch, Galveston