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Multifactorial Approach to Emergent Cerclage (RECIA)

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ClinicalTrials.gov Identifier: NCT01114516
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : October 10, 2014
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
William Grobman, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Insufficiency
Intervention Drug: Indomethacin and antibiotics (cefazolin or clindamycin)
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Indomethacin and Antibiotics
Hide Arm/Group Description emergent cerclage with no peri-operative antibiotics or indomethacin

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

Period Title: Overall Study
Started 26 27
Completed 24 26
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title Control Indomethacin and Antibiotics Total
Hide Arm/Group Description emergent cerclage with no peri-operative antibiotics or indomethacin

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 of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 26 participants 50 participants
28.7  (4.9) 31.9  (6.5) 30.3  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Female
24
 100.0%
26
 100.0%
50
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Hide Description Median gestational latency achieved Between Cerclage Placement and Time of Delivery
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Indomethacin and Antibiotics
Hide Arm/Group Description:
emergent cerclage with no peri-operative antibiotics or indomethacin

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

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: days
80
(15 to 122)
97
(57 to 125)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Indomethacin and Antibiotics
Comments Kaplan Meier survival analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Gestational Latency of More Than 28 Days
Hide Description The frequency of achieving a gestational latency of more than 28 days
Time Frame 28 days postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Indomethacin and Antibiotics
Hide Arm/Group Description:
emergent cerclage with no peri-operative antibiotics or indomethacin

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

Overall Number of Participants Analyzed 24 26
Measure Type: Number
Unit of Measure: percentage of participants
62.5 92.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Indomethacin and Antibiotics
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
1.06 to 2.05
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Median gestational age at delivery
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Indomethacin and Antibiotics
Hide Arm/Group Description:
emergent cerclage with no peri-operative antibiotics or indomethacin

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

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: weeks
31.1
(22.9 to 38.5)
34.8
(27.1 to 38.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Indomethacin and Antibiotics
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.393
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Neonatal Morbidity and Mortality
Hide Description Days spent in the neonatal intensive care unit
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Indomethacin and Antibiotics
Hide Arm/Group Description:
emergent cerclage with no peri-operative antibiotics or indomethacin

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

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: days
95
(11 to 112)
43
(19 to 107)
5.Secondary Outcome
Title Birthweight
Hide Description Median birthweight
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Indomethacin and Antibiotics
Hide Arm/Group Description:
emergent cerclage with no peri-operative antibiotics or indomethacin

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

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: grams
2488
(955 to 3175)
2850
(1440 to 3380)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Indomethacin and Antibiotics
Hide Arm/Group Description emergent cerclage with no peri-operative antibiotics or indomethacin

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

All-Cause Mortality
Control Indomethacin and Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Indomethacin and Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Indomethacin and Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Because this study was not adequately powered to detect differences in perinatal outcomes, whether this adjunctive therapy affects these outcomes remains uncertain.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Emily Miller
Organization: Northwestern University Feinberg School of Medicine
Phone: 3124724685
EMail: emily-miller-1@northwestern.edu
Layout table for additonal information
Responsible Party: William Grobman, Northwestern University
ClinicalTrials.gov Identifier: NCT01114516     History of Changes
Other Study ID Numbers: STU00019610
First Submitted: April 29, 2010
First Posted: May 3, 2010
Results First Submitted: September 8, 2014
Results First Posted: October 10, 2014
Last Update Posted: November 7, 2014