Trial Outcomes & Findings for Combined Vaginal Misoprostol and Perivascular Vasopressin (NCT NCT03815344)

Results Overview

The difference in hemoglobin levels between pre surgery and post surgery

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

74 participants

Primary outcome timeframe

1 hour

Results posted on

2024-01-09

Participant milestones
Measure	Standard Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg	Standard-Vaginal Misoprostol Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement . Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Overall Study STARTED	42	32
Overall Study COMPLETED	42	32
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Standard n=42 Participants Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg	Standard-Vaginal Misoprostol n=32 Participants Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement . Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg	Total n=74 Participants Total of all reporting groups
Age, Continuous	37.17 years STANDARD_DEVIATION 6.3 • n=42 Participants	37.10 years STANDARD_DEVIATION 6.8 • n=32 Participants	37.14 years STANDARD_DEVIATION 6.5 • n=74 Participants
Sex: Female, Male Female	42 Participants n=42 Participants	32 Participants n=32 Participants	74 Participants n=74 Participants
Sex: Female, Male Male	0 Participants n=42 Participants	0 Participants n=32 Participants	0 Participants n=74 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	42 Participants n=42 Participants	32 Participants n=32 Participants	74 Participants n=74 Participants

Timeframe: 1 hour

The difference in hemoglobin levels between pre surgery and post surgery

Outcome measures
Measure	Standard n=42 Participants Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg	Standard-Vaginal Misoprostol n=32 Participants Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement . Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Hemoglobin Levels Difference Between Pre and Post Surgery.	0.76 g/dL Standard Deviation .89	0.93 g/dL Standard Deviation 1.36

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Maimonides Medical Center

Phone: 7182836000