Back to resultsMultifactorial Approach to Emergent Cerclage (RECIA)
Primary Purpose
Cervical Insufficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indomethacin and antibiotics (cefazolin or clindamycin)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Insufficiency focused on measuring cervical insufficiency
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
Sites / Locations
- Prentice Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
indomethacin and antibiotics
Arm Description
emergent cerclage with no peri-operative antibiotics or indomethacin
perioperative antibiotics and indomethacin
Outcomes
Primary Outcome Measures
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
Secondary Outcome Measures
Gestational Latency of More Than 28 Days
The frequency of achieving a gestational latency of more than 28 days
Gestational Age at Delivery
Median gestational age at delivery
Neonatal Morbidity and Mortality
Days spent in the neonatal intensive care unit
Birthweight
Median birthweight
Full Information
NCT ID
NCT01114516
First Posted
April 29, 2010
Last Updated
November 5, 2014
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01114516
Brief Title
Multifactorial Approach to Emergent Cerclage
Acronym
RECIA
Official Title
Role in Emergent Cerclage of Indomethacin and Antibiotics
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Insufficiency
Keywords
cervical insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
emergent cerclage with no peri-operative antibiotics or indomethacin
Arm Title
indomethacin and antibiotics
Arm Type
Experimental
Arm Description
perioperative antibiotics and indomethacin
Intervention Type
Drug
Intervention Name(s)
Indomethacin and antibiotics (cefazolin or clindamycin)
Other Intervention Name(s)
indocin, cleocin, ancef
Intervention Description
q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
Primary Outcome Measure Information:
Title
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Description
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Gestational Latency of More Than 28 Days
Description
The frequency of achieving a gestational latency of more than 28 days
Time Frame
28 days postpartum
Title
Gestational Age at Delivery
Description
Median gestational age at delivery
Time Frame
24 weeks
Title
Neonatal Morbidity and Mortality
Description
Days spent in the neonatal intensive care unit
Time Frame
1 year
Title
Birthweight
Description
Median birthweight
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24807330
Citation
Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-1316. doi: 10.1097/AOG.0000000000000228.
Results Reference
result
Learn more about this trial
Multifactorial Approach to Emergent Cerclage
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