Trial Outcomes & Findings for Minimizing Nausea and Vomiting During Spinals for CS (NCT NCT02872935)

Results Overview

Did the subject report nausea? The subject will respond with yes or no.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes

Results posted on

2020-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo: Normal Saline 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose	Glycopyrrolate Group 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Overall Study STARTED	11	11
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo: Normal Saline 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose	Glycopyrrolate Group 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Overall Study Other	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo: Normal Saline n=11 Participants 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose	Glycopyrrolate Group n=11 Participants 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=11 Participants	0 Participants n=11 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants	11 Participants n=11 Participants	22 Participants n=22 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants	0 Participants n=11 Participants	0 Participants n=22 Participants
Sex: Female, Male Female	11 Participants n=11 Participants	11 Participants n=11 Participants	22 Participants n=22 Participants
Sex: Female, Male Male	0 Participants n=11 Participants	0 Participants n=11 Participants	0 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From the administration of the spinal anesthesia to delivery of baby - Total time 90minutes

Did the subject report nausea? The subject will respond with yes or no.

Outcome measures

Outcome measures
Measure	Placebo: Normal Saline n=11 Participants 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose	Glycopyrrolate Group n=11 Participants 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Number of Participants Who Reported Nausea	8 Participants	7 Participants

PRIMARY outcome

Timeframe: From the administration of the spinal anesthesia to delivery of baby; Total time 90minutes

This measure is observed by care team. Reported as vomiting, yes or no.

Outcome measures

Outcome measures
Measure	Placebo: Normal Saline n=11 Participants 1ml of Normal Saline will be given intravenously with the administering of the spinal dose Normal Saline: 1ml of normal saline will be given intravenously with the administration of the spinal dose	Glycopyrrolate Group n=11 Participants 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose Glycopyrrolate: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
Number of Participants Who Experienced Vomiting.	4 Participants	2 Participants

Adverse Events

Placebo: Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glycopyrrolate Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kokila Thenuwara

University of Iowa

Phone: 319-384-5876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place