Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA

Launched by WOMAN'S · Aug 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of outpatient oral antibiotics, specifically amoxicillin and azithromycin, on how long a pregnancy can continue after a woman's water bag has broken prematurely. Women between 18 to 22 weeks pregnant who have experienced this rupture and have no other complications may be eligible to participate. Before joining the study, patients will spend 24 hours in the hospital for monitoring. If they remain stable, they can choose to enroll and will be randomly assigned to either receive the antibiotics or not.

Participants who receive the antibiotics will take them at home for a week, while those in the control group will not take any antibiotics. Both groups will have regular check-ups with specialists to monitor their health. The main goal of the study is to see how long the pregnancy lasts after the water bag has broken and to compare the number of women who can continue their pregnancies until at least 23 weeks. It’s important for potential participants to know that they must not have certain medical conditions, such as diabetes or infections, to be considered for the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Singleton gestation
• • 2. Gestational age of greater than 18 0/7 but less than or equal to 22 6/7
• • 3. 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
• • 4. Greater than or equal to 18 years of age
• • 5. Those with no known drug allergies or significant adverse reactions to azithromycin or amoxicillin
• • 6. Afebrile at the time of presentation and throughout 24-hour observation period
• • 7. Patient must be able to provide informed consent
• Exclusion Criteria:
• • 1. Fetal anomalies in current pregnancy
• • 2. Diabetes mellitus, including both pre-gestational and gestational
• • 3. Abnormal placentation
• • 4. Poor dating with dating ultrasound performed later than or equal to 20 0/7 weeks
• • 5. Current subchorionic hemorrhage or current vaginal bleeding on presentation
• • 6. Hypertensive disease, including pre-gestational chronic hypertension, gestational hypertension and pre-eclampsia/eclampsia
• • 7. History of amniocentesis during this pregnancy
• • 8. History of cervical incompetence, history of cerclage in previous pregnancy or current cerclage in place
• • 9. Current documented urinary tract infection or bacteriuria
• • 10. Current documented genital tract infection (Chlamydia, gonorrhea, or trichomonas)
• • 11. 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)