Antibiotics for Water Breaking Early

(LAPROM Trial)

Overseen By Baha Sibai

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Latency antibiotics

Disqualifiers: Vaginal bleeding, Placenta previa, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 22 weeks gestation

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

Cervical dilatation is 3 cm or less (on visual or clinical examination)

Membrane rupture had occurred within 36 hours of randomization

4 or fewer contractions in the 60-minute monitoring period before randomization

Exclusion Criteria

Nonreassuring fetal testing

I have a cervical stitch in place.

Maternal or fetal indication for immediate delivery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of prophylactic antibiotics in expectant management of PPROM less than 22 weeks

Up to 22 weeks gestation

Follow-up

Participants are monitored for maternal postpartum infection and postpartum hemorrhage

6 weeks post-delivery

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

Trial Overview

The study tests if giving antibiotics right after the membranes rupture before week 22 helps delay delivery by at least a week, and if it reduces newborn complications when given between weeks 20 to 22.

How Is the Trial Designed?

Group I: Administration of antibiotics prophylactically at the time of membrane rupture Experimental Treatment 1 Intervention

Membrane rupture per inclusion criteria will be less than 22 weeks

Group II: Administration of antibiotics non-prophylactically at 22 weeks Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 207 women with preterm premature rupture of membranes, azithromycin resulted in a significantly longer latency period (14.09 days) compared to roxithromycin (7.87 days), suggesting it may be more effective in prolonging pregnancy.

Despite the longer latency with azithromycin, rates of chorioamnionitis, cesarean deliveries, Apgar scores, and birth weights were similar between the two groups, indicating that azithromycin is a safe and convenient first-line treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macrolide antibiotics roxithromycin vs. azithromycin for preterm premature rupture of membranes: a retrospective comparison. Schreiber, H., Shitrit, P., Man-El, G., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9546066/

Antibiotic prophylaxis in preterm premature rupture of ...

Antibiotic prophylaxis after PPROM at 24–31 weeks: 3rd‐generation cephalosporins associated with improved neonatal outcomes. Keywords: amoxicillin, antenatal ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589933323001209

Efficacy of prophylactic antibiotics for preterm premature ...

Penicillins remain the first choice for prophylaxis in preterm premature rupture of membranes. Clindamycin plus gentamicin is an alternative regimen.

3.

ajog.org

ajog.org/article/S0002-9378(25)00031-6/fulltext

No difference in outcomes with early vs late antibiotic ...

There was no substantial difference in the efficacy and safety of antibiotics administered within 6 to 12 hours after rupture of membranes compared with that ...

4.

obgyn.onlinelibrary.wiley.com

obgyn.onlinelibrary.wiley.com/doi/full/10.1002/ijgo.15045

Timing of antibiotic prophylaxis in term prelabor rupture of ...

The meta-analysis showed that antibiotic prophylaxis in women with term PROM was associated with significant decreases in infection for mothers ...

5.

ajogmfm.org

ajogmfm.org/article/S2589-9333(23)00120-9/pdf

Efficacy of prophylactic antibiotics for preterm premature ...

We aimed to evaluate the efficacy and safety of current anti- biotic regimens. Key findings Penicillins remain the first choice for prophylaxis in preterm ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK532888/

Preterm and Term Prelabor Rupture of Membranes (PPROM ...

After PROM at term, outcomes are generally favorable. Birth within 7 days of membrane rupture occurs in at least 50% of patients with PPROM.

7.

ajog.org

ajog.org/article/S0002-9378(24)00759-2/fulltext

Society for Maternal-Fetal Medicine Consult Series #71

Broad-spectrum antibiotics are recommended for the management of PPROM at <34 weeks of gestation and can be considered at 20 0/7 to 23 6/7 weeks ...

8.

obgyn.onlinelibrary.wiley.com

obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.70020

Management of preterm premature rupture of membranes ...

Antibiotic therapy serves as a core strategy in the management of PPROM, aiming to inhibit intrauterine infection, regulate excessive ...

9.

cureus.com

cureus.com/articles/368060-comparison-of-seven-day-versus-continuous-prophylactic-antibiotic-therapy-until-delivery-in-preterm-premature-rupture-of-membranes

Comparison of Seven-Day Versus Continuous Prophylactic ...

This study aimed to evaluate and compare maternal and neonatal outcomes in women with PPROM treated with prophylactic antibiotics for seven days ...