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Compensation: Varies

Number of Visits: Unknown

Duration: Up to 22 weeks gestation

60 Participants Needed

Antibiotics for Water Breaking Early
(LAPROM Trial)

Overseen ByBaha 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 GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug for treating early water breaking?

Research shows that using antibiotics when the water breaks early can help reduce the risk of infections in both the mother and baby, allowing more time for the baby's lungs to develop properly.¹ ² ³ ⁴ ⁵

Is it safe to use antibiotics when the water breaks early during pregnancy?

Research shows that using antibiotics when the water breaks early can help reduce the risk of infections for both the mother and baby. However, there are concerns about bacterial resistance (when bacteria stop responding to antibiotics) and the risk of allergic reactions in the mother, so it's important to weigh the benefits and risks carefully.¹ ² ⁶ ⁷ ⁸

How does the use of antibiotics for early water breaking differ from other treatments?

This treatment is unique because it involves administering antibiotics non-prophylactically at 22 weeks, which is earlier than typical prophylactic use at the time of membrane rupture. This approach aims to address infections earlier in the pregnancy, potentially reducing risks associated with preterm rupture of membranes.¹ ² ⁹ ¹⁰ ¹¹

Research Team

Khalil Chahine, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

See 3 more

Exclusion Criteria

Nonreassuring fetal testing

I have a cervical stitch in place.

Maternal or fetal indication for immediate delivery

See 6 more

Timeline

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

Treatment Details

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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Administration of antibiotics prophylactically at the time of membrane ruptureExperimental Treatment1 Intervention

Membrane rupture per inclusion criteria will be less than 22 weeks

Group II: Administration of antibiotics non-prophylactically at 22 weeksActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

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]