Trial Outcomes & Findings for Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine (NCT NCT00858832)
NCT ID: NCT00858832
Last Updated: 2012-09-19
Results Overview
Number of participants who developed endometritis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
One year
Results posted on
2012-09-19
Participant Flow
Recruitment began 01dec2008 and was terminated 30apr2010. All recruitment was in a hospital.
There were no washouts or run-ins. Patients were eligible upon the decision for a Cesarean delivery and then consented and randomized.
Participant milestones
| Measure |
Methergine
Participants received Methergine 0.2mg orally every 6 hours for 2 days
|
No Treatment
Participants received no intervention (no treatment).
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Methergine
Participants received Methergine 0.2mg orally every 6 hours for 2 days
|
No Treatment
Participants received no intervention (no treatment).
|
|---|---|---|
|
Overall Study
became ineligible: delivered vaginally
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
Baseline characteristics by cohort
| Measure |
Methergine
n=21 Participants
|
No Methergine
n=23 Participants
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One yearNumber of participants who developed endometritis
Outcome measures
| Measure |
Methergine
n=21 Participants
|
No Methergine
n=23 Participants
|
|---|---|---|
|
Endometritis Incidence
|
0 participants
|
0 participants
|
Adverse Events
Methergine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Methergine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methergine
n=21 participants at risk
|
No Methergine
n=23 participants at risk
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
elevated blood pressure
|
0.00%
0/21
|
4.3%
1/23
|
Additional Information
Patrick Teefey MD
USF Health Department of Obstetrics and Gynecology
Phone: 813-259-8680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place