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The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.
The overall objective of this prospective two-arm randomized study is to (1) randomize subjects to azithromycin surgical prophylaxis versus placebo, plus the standard of care - cefazolin, at the time of cerclage placement and evaluate the impact on preterm delivery <37 weeks, <34 weeks and <28 weeks and (2) determine the prevalence of mycoplasma species in cerclage patients. Pregnant women who are candidates for cervical cerclage will be enrolled and divided into two cohorts (approximately 40 per group): (1) Cerclage + Azithromycin prophylaxis (treatment group), and (2) Cerclage without azithromycin prophylaxis (control group). Both groups will receive otherwise usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage and Azithromycin Prophylaxis | Experimental | women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations |
|
| Cerclage Without Azithromycin Prophylaxis | Active Comparator | women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin Prophylaxis | Drug | 500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Latency from Cerclage to Delivery | Number of days from cerclage to delivery | Up to Week 42 |
| Gestational Age at Delivery | Gestational age at delivery measured in weeks and days | Up to Week 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Chorioamnionitis | number of participants with chorioamnionitis | Up to Week 42 |
| Incidence of Preterm Premature Birth | Number of participants that experienced preterm premature birth |
| Measure | Description | Time Frame |
|---|---|---|
| Neonate Birth Weight | weight of neonate at birth | day of delivery |
| Apgar Scores | The Apgar score is a standardized test used to rapidly assess a newborn's health immediately after birth. It is evaluated at 1 minute (to see how the baby handled delivery) and 5 minutes (to check how the baby is adapting to life outside the womb). Total score range is 0-10 with a higher score indicating newborn is adapting well to life outside the womb. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Harrison, MD | Contact | 616-218-2892 | rachel.harrison@aah.org |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Harrison, MD | advocate christ medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
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| ID | Term |
|---|---|
| D002581 | Uterine Cervical Incompetence |
| ID | Term |
|---|---|
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Azithromycin Placebo | Drug | normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area |
|
| Cefazolin | Drug | All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin. |
|
| 28 weeks gestation, 34 weeks gestation, 37 weeks gestation |
| Incidence of Preterm Premature Rupture of Membranes | Number of participants that experienced preterm premature rupture of membranes | up to 37 weeks gestation |
| Complications from Cerclage | Number participants that experienced complications from cerclage | Up to Week 42 |
| Prevalence of Mycoplasma Infection or Colonization | Number of participants with prevalence of mycoplasma infection or colonization | Up to Week 42 |
| 1 minute post delivery, 5 minutes post delivery |
| Number of NICU Admissions | number of neonates admitted to NICU after delivery | day of delivery |
| Length of NICU Admission | number of days neonates spent in NICU | up to month 12 |
| Neonate Survival Rate | percent of neonate survival | up to month 12 |
| Composite Neonate Morbidity | composite neonatal morbidity is a yes/no outcome that is considered yes if any of the adverse outcomes are positive | up to month 12 |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D000091662 | Genital Diseases |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |