← Back to Search

Antibiotic

Antibiotics for Premature Rupture of Membranes

Phase 4

Recruiting

Led By David Hackney, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, a basic pH (i.e., positive nitrazine) test of vaginal fluid, arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or an amniotic fluid index (AFI) of less than 4cm

Be older than 18 years old

Must not have

Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics

Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of delivery to date of hospital discharge (up to 6 months)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study the impact of antibiotics on how long a pregnant person can wait before giving birth after their water breaks before 28 weeks.

Who is the study for?

This trial is for English-speaking pregnant women with a single baby, between 18 and nearly 23 weeks along, who've had their water break early without labor starting. They must be able to consent and not want to end the pregnancy. Excluded are those with major fetal issues, recent related procedures or infections, certain medication use, heavy bleeding or fever at rupture time.

What is being tested?

The study tests if taking oral antibiotics (Azithromycin and Amoxicillin) after an early water break can delay birth beyond 28 days. It's a randomized trial where some get the drugs while others don't, aiming to see which group stays pregnant longer.

What are the potential side effects?

Possible side effects from Azithromycin and Amoxicillin include stomach upset like diarrhea or nausea, allergic reactions ranging from rashes to more severe responses in those sensitive to these antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My water broke early without labor starting, confirmed by a doctor's exam.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to macrolide or penicillin antibiotics.

Select...

I had a cervical stitch placed within a week after my water broke.

Select...

I want to end or induce my pregnancy.

Select...

I am on antibiotics since my water broke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of delivery to date of hospital discharge (up to 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of delivery to date of hospital discharge (up to 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of delivery to date of hospital discharge (up to 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Delivery within 28 days

Secondary study objectives

Severe maternal morbidity composite

Severe neonatal morbidity composite

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AntibioticsExperimental Treatment2 Interventions

Patients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days). Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.

Group II: No antibioticsActive Control1 Intervention

Patients randomized into the control (i.e., no antibiotics arm) will be managed according to standard of care practices for previable PPROM desiring of expectant management.

0 / 5Eligibility criteria met