Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture), Rupture of Membranes; Premature, Rupture of Membranes; Premature, Affecting Fetus
About this trial
This is an interventional treatment trial for Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture) focused on measuring Previable, PPROM, Premature prelabor rupture of membranes, Preterm, Preterm birth, Latency antibiotics
Eligibility Criteria
Inclusion Criteria:
- Singleton gestation
- Gestational age of greater than 18 0/7 but less than or equal to 22 6/7
- Diagnosis of prelabor premature rupture of membranes as determined by clinical examination noting either/or 1) visualization of amniotic fluid passing from the cervical canal and pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (ferning) of dried vaginal fluid identified via microscopic examination, or 4) an amniotic fluid index (AFI) of less than 4cm
- Greater than or equal to 18 years of age
- Those with no known drug allergies or significant adverse reactions to azithromycin or amoxicillin
- Afebrile at the time of presentation and throughout 24-hour observation period
- Patient must be able to provide informed consent
Exclusion Criteria:
- Fetal anomalies in current pregnancy
- Diabetes mellitus, including both pre-gestational and gestational
- Abnormal placentation
- Poor dating with dating ultrasound performed later than or equal to 20 0/7 weeks
- Current subchorionic hemorrhage or current vaginal bleeding on presentation
- Hypertensive disease, including pre-gestational chronic hypertension, gestational hypertension and pre-eclampsia/eclampsia
- History of amniocentesis during this pregnancy
- History of cervical incompetence, history of cerclage in previous pregnancy or current cerclage in place
- Current documented urinary tract infection or bacteriuria
- Current documented genital tract infection (Chlamydia, gonorrhea, or trichomonas)
- Immunocompromised (i.e., HIV positive, daily steroid use, or a history of autoimmune disease for which the patient is currently undergoing treatment with immunotherapy medication)
Sites / Locations
- Woman's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Antibiotics
No antibiotics
This will include those subjects randomized into the treatment arm, receiving the outpatient antibiotic course of azithromycin and amoxicillin prior to re-admission at viability (23 0/7 weeks gestation). They will receive a single, 500mg dose of Azithromycin given prior to discharge to home, followed by 250mg daily for 4 more days, and Amoxicillin 500mg orally TID for 7 days (first dose also being given prior to discharge home).
This will include those subjects randomized into the control arm and will not receive outpatient antibiotics prior to re-admission at viability (23 0/7 weeks gestation).