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Multifactorial Approach to Emergent Cerclage (RECIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01114516
First received: April 29, 2010
Last updated: April 30, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Cervical Insufficiency
 Drug: Indomethacin and antibiotics (cefazolin or clindamycin)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role in Emergent Cerclage of Indomethacin and Antibiotics

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Gestational latency achieved between cerclage placement and time of delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gestational age at delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Neonatal morbidity and mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    NICU days, birthweight


Estimated Enrollment: 53
Study Start Date: March 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
emergent cerclage with no peri-operative antibiotics or indomethacin
Experimental: indomethacin and antibiotics
perioperative antibiotics and indomethacin
 Drug: Indomethacin and antibiotics (cefazolin or clindamycin)
q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
Other Name: indocin, cleocin, ancef

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114516

Locations
United States, Illinois
Prentice Women's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Linda Fonseca, MD         Linda.Fonseca@nmff.org    
Contact: Barrett Robinson, MD, MPH         b-robinson@md.northwestern.edu    
Principal Investigator: Linda Fonseca, MD            
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: Linda Fonseca/Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01114516     History of Changes
Other Study ID Numbers: STU00019610
Study First Received: April 29, 2010
Last Updated: April 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
cervical insufficiency

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Clindamycin
Clindamycin-2-phosphate
Indomethacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Antirheumatic Agents
 Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013