Multifactorial Approach to Emergent Cerclage

Study Overview
=================
Brief 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.

Official Title
-----------------
Role in Emergent Cerclage of Indomethacin and Antibiotics

Conditions
-----------------
Cervical Insufficiency

Intervention / Treatment
-----------------
* Drug: Indomethacin and antibiotics (cefazolin or clindamycin)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>emergent cerclage with no peri-operative antibiotics or indomethacin | |
| Experimental: indomethacin and antibiotics<br>perioperative antibiotics and indomethacin | Drug: Indomethacin and antibiotics (cefazolin or clindamycin)<br>* q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin<br>* Other names: indocin, cleocin, ancef;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Latency Achieved Between Cerclage Placement and Time of Delivery | Median gestational latency achieved Between Cerclage Placement and Time of Delivery | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Latency of More Than 28 Days | The frequency of achieving a gestational latency of more than 28 days | 28 days postpartum | 
| Gestational Age at Delivery | Median gestational age at delivery | 24 weeks | 
| Neonatal Morbidity and Mortality | Days spent in the neonatal intensive care unit | 1 year | 
| Birthweight | Median birthweight | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical insufficiency