NCT04047849 Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
| NCT ID | NCT04047849 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Woman's |
| Condition | Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture) |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2019-08-28 |
| Primary Completion | 2021-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 34 participants in total. It began in 2019-08-28 with a primary completion date of 2021-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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. Patients will be admitted to the hospital for a 24-hour monitoring period. If the patient remains without further complications during this monitoring period, the patient will be eligible for enrollment. If enrollment is desired, the patient will be randomly assigned to receive either antibiotics (treatment arm of the study) or no antibiotics (control arm of the study). The treatment arm will receive an outpatient, 7-day course of oral antibiotics (azithromycin and amoxicillin) with the first dose given in the hospital to ensure no side effects. The control arm will not receive outpatient antibiotics. Both groups will have weekly, office follow-up visits with high-risk pregnancy specialists to ensure no further complications. Both groups will be admitted to the hospital if the patients reach 23 0/7 weeks without complications. At this time the patients will receive all medications and therapies recommended by the governing board of OBGYNs. Subjects of both groups will also be admitted before 23 0/7 weeks if further complications noted either at their clinic follow up visits or anytime outside of the hospital. The duration of time that the patient remains pregnant after breaking of the water bag will be compared in each group. The investigators will also see if there is a difference in the number of patients able to reach 23 0/7 weeks between each group (treatment versus control).
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)
Contact & Investigator
Robert C Moore, MD
PRINCIPAL INVESTIGATOR
Woman's Hospital, Louisiana
Frequently Asked Questions
Who can join the NCT04047849 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04047849 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04047849 currently recruiting?
Yes, NCT04047849 is actively recruiting participants. Contact the research team at fvenab@lsuhsc.edu for enrollment information.
Where is the NCT04047849 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT04047849 clinical trial?
NCT04047849 is sponsored by Woman's. The principal investigator is Robert C Moore, MD at Woman's Hospital, Louisiana. The trial plans to enroll 34 participants.