Pregnancy Preterm, Pregnancy Prom, Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor, Premature Birth, PROM (Pregnancy), PROM, Preterm (Pregnancy)
Conditions
Brief summary
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
Interventions
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).
DRUGAmoxicillin Pill
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.
Sponsors
University Hospitals Cleveland Medical Center
MetroHealth Medical Center
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery Within 28 Days | 28 days from date of rupture | The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Maternal Morbidity Composite | From diagnosis of membrane rupture to 6 weeks following delivery | The proportion of patient's "positive" for severe maternal morbidity composite. A patient will be termed "positive" for severe maternal morbidity composite if any one of the following is diagnosed: maternal sepsis, postpartum hemorrhage, maternal ICU admission, maternal death. |
| Severe Neonatal Morbidity Composite | From date of delivery to date of hospital discharge (up to 6 months) | The proportion of patient's "positive" for severe neonatal morbidity composite. A neonate will be termed "positive" for severe neonatal morbidity composite if any one of the following is diagnosis: bronchopulmonary dysplasia (BPD), pulmonary hypoplasia, intraventricular hemorrhage (IVH) grade III/IV, necrotizing enterocolitis (NEC) Bell's Stage II or greater, neonatal sepsis with positive blood cultures, neonatal pneumonia with positive blood cultures, neonatal death. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Hackney, MD
University Hospitals Cleveland Medical Center
PRINCIPAL_INVESTIGATORJustin Lappen, MD
The Cleveland Clinic
PRINCIPAL_INVESTIGATORBrian Mercer, MD
MetroHealth Hospitals
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 1 / 1 |
Outcome results
None listed