Cervical Insufficiency
Conditions
Keywords
short cervix, pregnancy prolongation, cerclage
Brief summary
The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.
Detailed description
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.
Interventions
DRUGAzithromycin Prophylaxis
500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
DRUGCefazolin
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.
DRUGProgesterone
progesterone 200 mg nightly after cerclage placement until 36 weeks gestation
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment * Indication for transvaginal cerclage placement * Intact amniotic membranes
Exclusion criteria
* Evidence of active infection or chorioamnionitis at presentation * Preterm prelabor rupture of membranes (PPROM) * Multiple gestation * HIV positive status * Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin) * Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome) * Major fetal anomaly or known chromosomal abnormalities that significantly affect viability * Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency from Cerclage to Delivery | Up to Week 42 | Number of days from cerclage to delivery |
| Gestational Age at Delivery | Up to Week 42 | Gestational age at delivery measured in weeks and days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Chorioamnionitis | Up to Week 42 | number of participants with chorioamnionitis |
| Incidence of Preterm Premature Birth | 28 weeks gestation, 34 weeks gestation, 37 weeks gestation | Number of participants that experienced preterm premature birth |
| Incidence of Preterm Premature Rupture of Membranes | up to 37 weeks gestation | Number of participants that experienced preterm premature rupture of membranes |
| Complications from Cerclage | Up to Week 42 | Number participants that experienced complications from cerclage |
| Prevalence of Mycoplasma Infection or Colonization | Up to Week 42 | Number of participants with prevalence of mycoplasma infection or colonization |
Countries
United States
Contacts
CONTACTRachel Harrison, MD
PRINCIPAL_INVESTIGATORRachel Harrison, MD
advocate christ medical center
Outcome results
None listed