Trial Outcomes & Findings for Multifactorial Approach to Emergent Cerclage (NCT NCT01114516)
NCT ID: NCT01114516
Last Updated: 2014-11-07
Results Overview
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
24 weeks
Results posted on
2014-11-07
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Multifactorial Approach to Emergent Cerclage
Baseline characteristics by cohort
| Measure |
Control
n=24 Participants
emergent cerclage with no peri-operative antibiotics or indomethacin
|
Indomethacin and Antibiotics
n=26 Participants
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
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.7 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
31.9 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
30.3 years
STANDARD_DEVIATION 6.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksMedian gestational latency achieved Between Cerclage Placement and Time of Delivery
Outcome measures
| Measure |
Control
n=24 Participants
emergent cerclage with no peri-operative antibiotics or indomethacin
|
Indomethacin and Antibiotics
n=26 Participants
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
|
|---|---|---|
|
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
|
80 days
Interval 15.0 to 122.0
|
97 days
Interval 57.0 to 125.0
|
SECONDARY outcome
Timeframe: 28 days postpartumThe frequency of achieving a gestational latency of more than 28 days
Outcome measures
| Measure |
Control
n=24 Participants
emergent cerclage with no peri-operative antibiotics or indomethacin
|
Indomethacin and Antibiotics
n=26 Participants
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
|
|---|---|---|
|
Gestational Latency of More Than 28 Days
|
62.5 percentage of participants
|
92.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksMedian gestational age at delivery
Outcome measures
| Measure |
Control
n=24 Participants
emergent cerclage with no peri-operative antibiotics or indomethacin
|
Indomethacin and Antibiotics
n=26 Participants
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
|
|---|---|---|
|
Gestational Age at Delivery
|
31.1 weeks
Interval 22.9 to 38.5
|
34.8 weeks
Interval 27.1 to 38.4
|
SECONDARY outcome
Timeframe: 1 yearDays spent in the neonatal intensive care unit
Outcome measures
| Measure |
Control
n=24 Participants
emergent cerclage with no peri-operative antibiotics or indomethacin
|
Indomethacin and Antibiotics
n=26 Participants
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
|
|---|---|---|
|
Neonatal Morbidity and Mortality
|
95 days
Interval 11.0 to 112.0
|
43 days
Interval 19.0 to 107.0
|
SECONDARY outcome
Timeframe: 24 weeksMedian birthweight
Outcome measures
| Measure |
Control
n=24 Participants
emergent cerclage with no peri-operative antibiotics or indomethacin
|
Indomethacin and Antibiotics
n=26 Participants
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
|
|---|---|---|
|
Birthweight
|
2488 grams
Interval 955.0 to 3175.0
|
2850 grams
Interval 1440.0 to 3380.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Indomethacin and Antibiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Emily Miller
Northwestern University Feinberg School of Medicine
Phone: 3124724685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place