N/A
N=53
Multifactorial Approach to Emergent Cerclage
Cervical Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01114516 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Gestational Latency Achieved Between Cerclage Placement and Time of Delivery — 80; 97 days — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indomethacin and antibiotics (cefazolin or clindamycin) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gestational Latency Achieved Between Cerclage Placement and Time of Delivery |
80; 97 | 0.018 sig |
| SECONDARY Gestational Latency of More Than 28 Days |
62.5; 92.3 | — |
| SECONDARY Gestational Age at Delivery |
31.1; 34.8 | 0.393 |
| SECONDARY Neonatal Morbidity and Mortality |
95; 43 | — |
| SECONDARY Birthweight |
2488; 2850 | — |
Summary
Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.
The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.
Eligibility Criteria
Inclusion Criteria
- GA 16+0 to 23+6 weeks
- Singleton gestation
- Presence of cervical dilation as diagnosed on digital examination
- Intact membranes
Exclusion Criteria
- Age <18 years
- Allergy to NSAIDs
- Renal disease
- Allergy to penicillins AND clindamycin
- Currently on antibiotics or indomethacin for any reason
- HIV positive
- Pregnancies complicated by fetal congenital anomalies
- Preterm premature rupture of membranes
- Fever of 100.4 degrees Fahrenheit or higher
- Any patient having received a therapeutic cerclage during the current pregnancy
Data sourced from ClinicalTrials.gov (NCT01114516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.