Trial Outcomes & Findings for Uterotonic Prophylaxis Trial (NCT 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

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

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=5 Participants	25 years n=7 Participants	24.8 years n=5 Participants
Sex: Female, Male Female	140 Participants n=5 Participants	144 Participants n=7 Participants	284 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic white	39 Participants n=5 Participants	48 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic black	26 Participants n=5 Participants	33 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Mixed	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Body mass index	26.5 kg/m2 n=5 Participants	26 kg/m2 n=7 Participants	26.3 kg/m2 n=5 Participants
Nulliparous	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Prior cesarean section	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Gestation	21.6 weeks n=5 Participants	21.5 weeks n=7 Participants	21.6 weeks n=5 Participants
Needed mechanical dilation	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Length of procedure	12 minutes n=5 Participants	12 minutes n=7 Participants	12 minutes n=5 Participants
Procedural measured blood loss	300 mL n=5 Participants	250 mL n=7 Participants	275 mL n=5 Participants
Current or recent cocaine or methamphetamine use	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
History of bleeding disorder	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Preoperative systolic BP	112 mmHg STANDARD_DEVIATION 11 • n=5 Participants	112 mmHg STANDARD_DEVIATION 10 • n=7 Participants	112 mmHg STANDARD_DEVIATION 10 • n=5 Participants
Preoperative diastolic BP	68 mmHg STANDARD_DEVIATION 9 • n=5 Participants	69 mmHg STANDARD_DEVIATION 8 • n=7 Participants	69 mmHg STANDARD_DEVIATION 8 • n=5 Participants

PRIMARY outcome

Timeframe: Approximately 1-2 hours after procedure

Outcome measures

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 procedure

post-procedure blood loss measured in recovery room

Outcome measures

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 hospital

number of participants who had a balloon tamponade placed

Outcome measures

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 discharge

Returned to OR for re-aspiration

Outcome measures

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 discharge

hospital admission for bleeding post-procedure

Outcome measures

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 discharge

any uterotonic medication given intraoperative or postoperative

Outcome measures

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 procedure

Patients' completed survey regarding side effects in recovery room.

Outcome measures

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 procedure

Patients' completed survey regarding side effects in recovery room.

Outcome measures

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 procedure

Patients' completed survey regarding side effects in recovery room.

Outcome measures

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

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

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

Jennifer Kerns

UCSF

Phone: 4152068715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place