Trial Outcomes & Findings for Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation (NCT NCT02083809)

NCT ID: NCT02083809

Last Updated: 2020-11-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 166 participants
• Primary outcome timeframe: During surgical procedure
• Results posted on: 2020-11-27

Participant Flow

Participant milestones

Measure	Placebo 500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid	Treatment Group Intravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
Overall Study STARTED	82	84
Overall Study COMPLETED	78	82
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

Baseline characteristics by cohort

Measure	Placebo n=78 Participants 500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid	Treatment Group n=82 Participants Intravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)	Total n=160 Participants Total of all reporting groups
Age, Continuous	27.2 age STANDARD_DEVIATION 7.2 • n=5 Participants	25.4 age STANDARD_DEVIATION 7 • n=7 Participants	26.3 age STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	82 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: During surgical procedure

Outcome measures

Measure	Placebo n=78 Participants 500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid	Treatment Group n=82 Participants Intravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.	13 Participants	6 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=78 participants at risk 500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid	Treatment Group n=82 participants at risk Intravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
Reproductive system and breast disorders cervical laceration	1.3% 1/78 • Number of events 1 • 1 day laceration of the cervix requiring repair with suturing	1.2% 1/82 • Number of events 1 • 1 day laceration of the cervix requiring repair with suturing

Other adverse events

Adverse event data not reported

Additional Information

Dr.

University of Hawaii

Phone: 8082036500

Email: whrc@ucera.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place