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New treatment option for Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture)
Official title Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
ClinicalTrials.gov ID: NCT04047849
What this study is testing
What is Antibiotics, oral Azithromycin and oral Amoxicillin?
Antibiotics, oral Azithromycin and oral Amoxicillin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for rupture of membranes; delayed delivery (following spontaneous rupture).
Also referred to as Z-pack.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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) that pregnancy continues after a patient's water bag has ruptured prematurely. If a patient has been diagnosed with rupture of their water bag between 18 0/7 weeks and 22 6/7 weeks and there are no other associated complications with the pregnancy, the patient is eligible for initial consideration for this study.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Greater than or equal to 18 years of age
- Those with no known drug allergies or significant adverse reactions to azithromycin or amoxicillin
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.