WithdrawnPhase 4

Latency Antibiotics for Previable Rupture Of Membranes Trial

Stopped: PI has decided to end study due to changes in Texas law and no participants were enrolled

0Started 2025-05-01

Plain-language summary

The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.

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: * Preterm premature rupture of membranes at less than 22 weeks. * Membrane rupture had occurred within 36 hours of randomization. * Cervical dilatation is 3 cm or less (on visual or clinical examination). * 4 or fewer contractions in the 60-minute monitoring period before randomization. * Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age * Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information. Exclusion Criteria: * Nonreasoning fetal testing * Vaginal bleeding * Maternal or fetal indication for immediate delivery * Cervical cerclage in place * Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin) * Allergy to Penicillins or Azithromycin * Febrile illness requiring antibiotics * Placenta previa * Multifetal gestation

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

Number of participants that delivered their babies after membrane rupture

Timeframe: from baseline to day 7

Trial details

NCT IDNCT06917157

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

View on ClinicalTrials.gov More Preterm Prelabor Rupture of Membranes (PPROM) trials