Trial Outcomes & Findings for Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI) (NCT NCT01481740)

NCT ID: NCT01481740

Last Updated: 2018-04-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 178 participants
• Primary outcome timeframe: intraoperative 2-3 hours
• Results posted on: 2018-04-23

Participant Flow

Participant milestones

Measure	Phenylephrine Bolus Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Overall Study STARTED	90	88
Overall Study COMPLETED	79	81
Overall Study NOT COMPLETED	11	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

Baseline characteristics by cohort

Measure	Phenylephrine Bolus n=79 Participants Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion n=81 Participants phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus	Total n=160 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 6 • n=5 Participants	31 years STANDARD_DEVIATION 5 • n=7 Participants	31 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	81 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
Region of Enrollment Canada	54 participants n=5 Participants	56 participants n=7 Participants	110 participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: intraoperative 2-3 hours

Outcome measures

Measure	Phenylephrine Bolus n=79 Participants Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion n=81 Participants phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Incidence of Nausea and Vomiting	59 participants	37 participants

PRIMARY outcome

Timeframe: 2 hrs postoperative

Outcome measures

Measure	Phenylephrine Bolus n=79 Participants Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion n=81 Participants phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Incidence of Nausea and Vomiting	29 participants	26 participants

PRIMARY outcome

Timeframe: 24hrs postoperative

Outcome measures

Measure	Phenylephrine Bolus n=79 Participants Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion n=81 Participants phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Incidence of Nausea and Vomiting	26 participants	28 participants

SECONDARY outcome

Timeframe: intraoperative - predelivery

Outcome measures

Measure	Phenylephrine Bolus n=79 Participants Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion n=81 Participants phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Incidence of Hypotension	59 participants	22 participants

SECONDARY outcome

Timeframe: intraoperative - postdelivery

Outcome measures

Measure	Phenylephrine Bolus n=79 Participants Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion n=81 Participants phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Incidence of Hypotension	34 participants	6 participants

SECONDARY outcome

Timeframe: intraoperative

Outcome measures

Measure	Phenylephrine Bolus n=79 Participants Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion	Phenylephrine Infusion n=81 Participants phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Neonatal Acidosis	7.27 pH value Standard Deviation 0.06	7.27 pH value Standard Deviation 0.07

Adverse Events

Phenylephrine Bolus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phenylephrine Infusion

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. Ronald B George

Department of Women's & Obstetric Anesthesia, IWK Health Centre

Phone: 902-470-6627

Email: rbgeorge@dal.ca

Results disclosure agreements

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