Trial Outcomes & Findings for Uterotonic Prophylaxis Trial (NCT NCT02408965)
NCT ID: NCT02408965
Last Updated: 2019-09-06
Results Overview
Clinical factors included in composite outcome of excessive bleeding after D\&E: Post-procedure total blood loss \> 125cc (after D\&E) Transfusion Admission for bleeding Re-aspiration for bleeding Balloon tamponade Uterine artery embolization Major surgery for bleeding At least 1 uterotonic medication given Prescription given for any uterotonic medication at discharge Uterine compression (uterine massage or manual pressure for 2 minutes
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
284 participants
Primary outcome timeframe
Approximately 1-2 hours after procedure
Results posted on
2019-09-06
Participant Flow
Determined ineligible (n=28) Patient withdrew (n=6) Administrative error (n=2)
Participant milestones
| Measure |
Methergine
Methergine group
|
Placebo
Placebo group
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
144
|
|
Overall Study
COMPLETED
|
140
|
144
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uterotonic Prophylaxis Trial
Baseline characteristics by cohort
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.5 years
n=99 Participants
|
25 years
n=107 Participants
|
24.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
39 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic black
|
26 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
37 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Body mass index
|
26.5 kg/m2
n=99 Participants
|
26 kg/m2
n=107 Participants
|
26.3 kg/m2
n=206 Participants
|
|
Nulliparous
|
35 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Prior cesarean section
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Gestation
|
21.6 weeks
n=99 Participants
|
21.5 weeks
n=107 Participants
|
21.6 weeks
n=206 Participants
|
|
Needed mechanical dilation
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Length of procedure
|
12 minutes
n=99 Participants
|
12 minutes
n=107 Participants
|
12 minutes
n=206 Participants
|
|
Procedural measured blood loss
|
300 mL
n=99 Participants
|
250 mL
n=107 Participants
|
275 mL
n=206 Participants
|
|
Current or recent cocaine or methamphetamine use
|
11 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
History of bleeding disorder
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Preoperative systolic BP
|
112 mmHg
STANDARD_DEVIATION 11 • n=99 Participants
|
112 mmHg
STANDARD_DEVIATION 10 • n=107 Participants
|
112 mmHg
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Preoperative diastolic BP
|
68 mmHg
STANDARD_DEVIATION 9 • n=99 Participants
|
69 mmHg
STANDARD_DEVIATION 8 • n=107 Participants
|
69 mmHg
STANDARD_DEVIATION 8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 1-2 hours after procedureClinical factors included in composite outcome of excessive bleeding after D\&E: Post-procedure total blood loss \> 125cc (after D\&E) Transfusion Admission for bleeding Re-aspiration for bleeding Balloon tamponade Uterine artery embolization Major surgery for bleeding At least 1 uterotonic medication given Prescription given for any uterotonic medication at discharge Uterine compression (uterine massage or manual pressure for 2 minutes
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria
|
78 Participants
|
75 Participants
|
PRIMARY outcome
Timeframe: measured 1 to 2 hours after procedurepost-procedure blood loss measured in recovery room
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Amount of Post-procedure Blood Loss Measured in mL
|
126 mL
Interval 86.0 to 166.0
|
76 mL
Interval 65.0 to 88.0
|
PRIMARY outcome
Timeframe: duration of procedure and until discharged from hospitalnumber of participants who had a balloon tamponade placed
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge
|
20 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: from cervical preparation through dischargeReturned to OR for re-aspiration
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Participants Who Returned to OR for Re-aspiration During Recovery Period
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: post-procedure and during recovery until dischargehospital admission for bleeding post-procedure
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Participants Who Were Admitted for Bleeding After Procedure
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: intra-operative or post-operative until dischargeany uterotonic medication given intraoperative or postoperative
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Participants Given Any Uterotonic
|
56 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Assessed approximately 1 hour after procedurePatients' completed survey regarding side effects in recovery room.
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Participants Who Reported Nausea up to One Hour After Procedure
|
42 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Assessed approximately 1 hour after procedurePatients' completed survey regarding side effects in recovery room.
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Patients Who Reported Vomiting up to One Hour After Procedure
|
18 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Assessed approximately 1 hour after procedurePatients' completed survey regarding side effects in recovery room.
Outcome measures
| Measure |
Methergine
n=140 Participants
Methergine group
|
Placebo
n=144 Participants
Placebo group
|
|---|---|---|
|
Number of Participants Who Reported Cramping up to One Hour After Procedure
|
100 Participants
|
84 Participants
|
Adverse Events
Methergine
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methergine
n=140 participants at risk
Methergine group
|
Placebo
n=144 participants at risk
Placebo group
|
|---|---|---|
|
Reproductive system and breast disorders
admission to hospital for bleeding
|
2.9%
4/140 • Number of events 4 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
0.00%
0/144 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
Other adverse events
| Measure |
Methergine
n=140 participants at risk
Methergine group
|
Placebo
n=144 participants at risk
Placebo group
|
|---|---|---|
|
Reproductive system and breast disorders
Balloon tamponade
|
14.3%
20/140 • Number of events 20 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
6.9%
10/144 • Number of events 10 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
|
Reproductive system and breast disorders
reasperation
|
2.9%
4/140 • Number of events 4 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
0.69%
1/144 • Number of events 1 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
|
Reproductive system and breast disorders
transfusion
|
2.1%
3/140 • Number of events 3 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
0.00%
0/144 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
|
Reproductive system and breast disorders
uterine artery embolization
|
1.4%
2/140 • Number of events 2 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
0.00%
0/144 • 2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place