Preterm Birth Clinical Trial
— ALECOfficial title:
Azithromycin to Improve Latency in Exam Indicated Cerclage: a Randomized Control Trial
Azithromycin is an antibiotic that is effective against bacteria that been associated with preterm birth (PTB). The purpose of this study is to evaluate if the addition of azithromycin prior to exam indicated cerclage prolongs gestation. A cerclage is a suture placed in the cervix to prolong gestation.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Pregnant women with singleton pregnancies - =18 years old - Estimated gestational age less than 24 weeks - Meet criteria for an exam indicated cerclage - Patients must also be able to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. Exclusion Criteria: - Human immunodeficiency virus (HIV) positive status - Known prolonged QT syndrome - Major fetal congenital anomalies - Temperature of 100.4 F or higher - Prior cerclage during the current pregnancy - Contraindication to indomethacin - Allergy to both penicillin and clindamycin - Received indomethacin or any antibiotics within 7 days before their presentation |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
United States | Rutgers Robert Wood Johnson | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gestational Latency Achieved Between Cerclage Placement and Time of Delivery | Mean gestational latency achieved Between Cerclage Placement and Time of Delivery | 24 weeks following cerclage placement | |
Secondary | Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks | Preterm delivery stratified by gestational age at delivery in weeks | at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement. | |
Secondary | Mean gestational age at delivery | Measured in weeks | at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement. | |
Secondary | chorioamnionitis | Histologic or clinical diagnosis | at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement. | |
Secondary | birth weight | measured in grams | at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement. | |
Secondary | Admission to neonatal intensive care unit | If admitted, measured in days | at delivery following cerclage placement. Latest will occur 26 weeks following cerclage placement. | |
Secondary | Neonatal Morbidity and Mortality | including apgars, Respiratory Distress Syndrome, Bronchopulmonary dysplasia, Retinopathy of prematurity, Intraventricular hemorrhage (IVH) (grade 3 or 4), patent ductus arteriosus, and neonatal death | within 28 days of delivery | |
Secondary | Cervicovaginal cytokine analysis | Measurement of proinflammatory cytokines in pg/ml (IL-1B, IL-2, IL-4, IL-6, IL-8, IL-8, IL-10, G-CSF, GM-CSF, MCP-1, TNF-a, IFN-g, CCL5, VEGF, ICAM-1) from cervicovaginal fluid at the time of cerclage placement and at follow up 1-4 weeks after placement | Cerclage placement and 1-4 weeks after |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
Completed |
NCT04811742 -
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
|
N/A |