Status:
RECRUITING
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Lead Sponsor:
Woman's
Conditions:
Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture)
Rupture of Membranes; Premature
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study is a non-blinded, prospective, randomized controlled trial designed to compare the effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of time (days) th...
Detailed Description
Throughout this detailed description, patient and subject will be used interchangeably. Patients presenting to either an acute care setting (Woman's Hospital Assessment Center) or outpatient clinic s...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04047849
Start Date
August 28 2019
End Date
July 1 2021
Last Update
January 11 2021
Active Locations (1)
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1
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817