Using outpatient antibiotics for pregnant women with early membrane rupture
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
PHASE4 · University Hospitals Cleveland Medical Center · NCT05345457
This study is testing if giving oral antibiotics to pregnant women with early membrane rupture can help delay their delivery for at least 28 days.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospitals Cleveland Medical Center (other) |
| Locations | 3 sites (Cleveland, Ohio and 2 other locations) |
| Trial ID | NCT05345457 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of oral antibiotics, specifically azithromycin and amoxicillin, in prolonging the time before delivery in pregnant women who experience previable rupture of membranes between 18 and 22 weeks of gestation. It is a randomized, controlled trial that aims to determine if these antibiotics can help delay labor for at least 28 days after the rupture. Participants will be monitored for their delivery outcomes following treatment. The study focuses on a specific gestational age range and includes various clinical assessments to confirm the diagnosis of membrane rupture.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking pregnant women with a singleton gestation who experience prelabor rupture of membranes between 18 and 22 weeks of gestation.
Not a fit: Patients who have a known major fetal anomaly, desire pregnancy interruption, or have undergone certain procedures shortly before the diagnosis of membrane rupture may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help extend the pregnancy duration for women experiencing early membrane rupture, potentially improving neonatal outcomes.
How similar studies have performed: While the approach of using antibiotics in this context is being explored, the specific application in this gestational age range is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking * Pregnant * Live, singleton gestation * Patient able to provide informed consent * Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture * Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm Exclusion Criteria: * Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational age * Patient desires pregnancy interruption or induction of labor * Known major fetal anomaly or aneuploidy * Amniocentesis ≤ 7 days of diagnosis of rupture of membranes * Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes * Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics * Current antibiotic use at the time of membrane rupture diagnosis * Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis * Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees Celsius) and/or within first 24 hours of diagnosis * Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis * Cervical dilation of ≥ 4 cm * Prolapse of fetal parts beyond the level of the internal cervical os * Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation
Where this trial is running
Cleveland, Ohio and 2 other locations
- University Hospitals — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
- MetroHealth — Cleveland, Ohio, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: David Hackney, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Felicia LeMoine, MD
- Email: felicia.lemoine@uhhospitals.org
- Phone: (216) 983-6606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Preterm, Pregnancy Prom, PROM, Preterm, PROM, Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor, Premature Birth