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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: November 5, 2014
Last verified: November 2014
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cervical Insufficiency
Intervention: Drug: Indomethacin and antibiotics (cefazolin or clindamycin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control emergent cerclage with no peri-operative antibiotics or indomethacin
Indomethacin and Antibiotics

perioperative antibiotics and indomethacin

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


Participant Flow:   Overall Study
    Control     Indomethacin and Antibiotics  
STARTED     26     27  
COMPLETED     24     26  
NOT COMPLETED     2     1  
Lost to Follow-up                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control emergent cerclage with no peri-operative antibiotics or indomethacin
Indomethacin and Antibiotics

perioperative antibiotics and indomethacin

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

Total Total of all reporting groups

Baseline Measures
    Control     Indomethacin and Antibiotics     Total  
Number of Participants  
[units: participants]
  24     26     50  
Age  
[units: years]
Mean ± Standard Deviation
  28.7  ± 4.9     31.9  ± 6.5     30.3  ± 6.0  
Gender  
[units: participants]
     
Female     24     26     50  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Gestational Latency Achieved Between Cerclage Placement and Time of Delivery   [ Time Frame: 24 weeks ]

2.  Secondary:   Gestational Latency of More Than 28 Days   [ Time Frame: 28 days postpartum ]

3.  Secondary:   Gestational Age at Delivery   [ Time Frame: 24 weeks ]

4.  Secondary:   Neonatal Morbidity and Mortality   [ Time Frame: 1 year ]

5.  Secondary:   Birthweight   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Because this study was not adequately powered to detect differences in perinatal outcomes, whether this adjunctive therapy affects these outcomes remains uncertain.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Emily Miller
Organization: Northwestern University Feinberg School of Medicine
phone: 3124724685
e-mail: emily-miller-1@northwestern.edu


Publications of Results:

Responsible Party: William Grobman, 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: November 5, 2014
Health Authority: United States: Institutional Review Board