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Antibiotic
Antibiotics for Premature Rupture of Membranes
Phase 4
Recruiting
Led By Brian Mercer, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of delivery to date of hospital discharge (up to 6 months)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My water broke early without labor starting, confirmed by a doctor's exam.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delivery within 28 days
Secondary outcome measures
Severe maternal morbidity composite
Severe neonatal morbidity composite
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.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicOTHER
1,027 Previous Clinical Trials
1,364,190 Total Patients Enrolled
University Hospitals Cleveland Medical CenterLead Sponsor
318 Previous Clinical Trials
340,147 Total Patients Enrolled
2 Trials studying Premature Birth
114 Patients Enrolled for Premature Birth
MetroHealth Medical CenterOTHER
114 Previous Clinical Trials
21,301 Total Patients Enrolled
2 Trials studying Premature Birth
124 Patients Enrolled for Premature Birth
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to macrolide or penicillin antibiotics.I had a cervical stitch placed within a week after my water broke.I had a fever of 38°C or higher when my membrane ruptured or within the first 24 hours.I want to end or induce my pregnancy.I am on antibiotics since my water broke.My water broke early without labor starting, confirmed by a doctor's exam.
Research Study Groups:
This trial has the following groups:- Group 1: Antibiotics
- Group 2: No antibiotics
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration for this experiment open to participants?
"Clinicaltrials.gov states that this medical study is currently in the process of enrolling patients, with its origin on January 13th 2023 and most recent update being February 11th 2023."
Answered by AI
To what degree can antibiotics be relied upon to safeguard patient health?
"The safety rating assigned to antibiotics by our team at Power was a 3, as this is an officially licensed Phase 4 trial."
Answered by AI
What is the scope of individuals included in this trial?
"Affirmative. The clinicaltrials.gov database confirms that this medical trial is currently recruiting, with the first post being published on January 13th 2023 and the last edit occurring February 11th of the same year. 88 participants are required from 3 distinct sites."
Answered by AI
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