Antibiotics for Water Breaking Early
(LAPROM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if administering antibiotics early can delay birth and improve baby health for those experiencing preterm premature rupture of membranes (PPROM) before 22 weeks of pregnancy. It will compare two approaches: administering antibiotics immediately when the water breaks (prophylactically) or waiting until the 22nd week (non-prophylactically). The trial seeks participants who have experienced their water breaking before 22 weeks, have minimal cervical dilation, and are carrying one baby. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you have already received certain antibiotics like azithromycin, ampicillin, or amoxicillin before joining.
What is the safety track record for these treatments?
Previous studies have shown that antibiotics can be safely used for women with preterm premature rupture of membranes (PPROM). Research indicates that ampicillin, a common antibiotic, is often the first choice and is well-tolerated. The Society for Maternal-Fetal Medicine recommends antibiotics to manage PPROM because they help prevent infections and improve outcomes for both mothers and babies.
At 22 weeks, broad-spectrum antibiotics, which work against many types of bacteria, are considered safe and are recommended in similar situations. These antibiotics help manage and reduce the risk of infections.
Overall, both preventative and non-preventative antibiotics have a strong record of being tolerated by pregnant women with PPROM. They play a crucial role in reducing risks to newborns, such as infections, while remaining safe for mothers.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for early membrane rupture because they explore different timings for antibiotic administration. Unlike the usual practice of giving antibiotics only after the membranes rupture, this trial looks at giving them proactively at 22 weeks, which could potentially prevent infections before they start. This approach might offer better protection for both the mother and baby, reducing risks associated with premature birth. By comparing these methods, researchers hope to find a more effective way to manage early membrane rupture and improve outcomes for expecting mothers and their babies.
What evidence suggests that this trial's treatments could be effective for PPROM?
This trial will compare two approaches to administering antibiotics when a mother's water breaks early. One group will receive antibiotics prophylactically at the time of membrane rupture, while another group will receive antibiotics non-prophylactically at 22 weeks. Studies have shown that administering antibiotics immediately when a mother's water breaks can improve the health of babies born early. Penicillin, often the first choice, has effectively reduced infections in both mothers and babies. Research suggests that early antibiotic administration can lower the chances of delivering within a week after the water breaks, reducing risks for the newborn. Although some studies indicate that timing might not always significantly impact outcomes, antibiotics have generally been linked to better health for premature babies.26789
Who Is on the Research Team?
Khalil Chahine, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for pregnant individuals with a single baby, whose water broke early (before 22 weeks), and who haven't had antibiotics or other disqualifying conditions. They should have minimal contractions and no more than 3 cm cervical dilation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Administration of prophylactic antibiotics in expectant management of PPROM less than 22 weeks
Follow-up
Participants are monitored for maternal postpartum infection and postpartum hemorrhage
What Are the Treatments Tested in This Trial?
Interventions
- Administration of antibiotics non-prophylactically at 22 weeks
- Administration of antibiotics prophylactically at the time of membrane rupture
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor