- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01114516
Multifactorial Approach to Emergent Cerclage (RECIA)
Role in Emergent Cerclage of Indomethacin and Antibiotics
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Prentice Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
emergent cerclage with no peri-operative antibiotics or indomethacin
|
|
Experimental: indomethacin and antibiotics
perioperative antibiotics and indomethacin
|
q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Time Frame: 24 weeks
|
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
Time Frame: 28 days postpartum
|
The frequency of achieving a gestational latency of more than 28 days
|
28 days postpartum
|
Gestational Age at Delivery
Time Frame: 24 weeks
|
Median gestational age at delivery
|
24 weeks
|
Neonatal Morbidity and Mortality
Time Frame: 1 year
|
Days spent in the neonatal intensive care unit
|
1 year
|
Birthweight
Time Frame: 24 weeks
|
Median birthweight
|
24 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Uterine Cervical Diseases
- Uterine Diseases
- Pregnancy Complications
- Abortion, Habitual
- Abortion, Spontaneous
- Uterine Cervical Incompetence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Protein Synthesis Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Anti-Bacterial Agents
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Cefazolin
- Indomethacin
Other Study ID Numbers
- STU00019610
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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