Multifactorial Approach to Emergent Cerclage (RECIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Grobman, Northwestern University
ClinicalTrials.gov Identifier:
NCT01114516
First received: April 29, 2010
Last updated: October 5, 2014
Last verified: October 2014
  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:


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 ]
    Median gestational latency achieved Between Cerclage Placement and Time of Delivery


Secondary Outcome Measures:
  • Gestational Age at Delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Median gestational age at delivery

  • Neonatal Morbidity and Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Frequency of Neonatal morbidity and mortality

  • Birthweight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Median birthweight


Enrollment: 53
Study Start Date: March 2010
Study Completion Date: March 2014
Primary Completion Date: March 2013 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01114516

Locations
United States, Illinois
Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  More Information

Publications:
Responsible Party: William Grobman, principal investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01114516     History of Changes
Other Study ID Numbers: STU00019610
Study First Received: April 29, 2010
Results First Received: September 8, 2014
Last Updated: October 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
cervical insufficiency

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

ClinicalTrials.gov processed this record on October 19, 2014