Trial Outcomes & Findings for Phenylephrine in Spinal Anesthesia in Preeclamptic Patients (NCT NCT00458003)

Last Updated: 2022-06-02

Results Overview

The umbilical artery blood pH immediately after delivery. The pH scale ranges from 0 to 14. A normal pH sample from the umbilical artery ranges from pH: 7.18 - 7.38. The lower the pH the more acidic and the higher the pH the more basic.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

Immediately after delivery

Results posted on

2022-06-02

Participant Flow

The number of women enrolled in the study.

Participant milestones

Participant milestones
Measure	Phenylephrine Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
Overall Study STARTED	55	55
Overall Study COMPLETED	54	54
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phenylephrine Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
Overall Study Non protocol spinal anesthesia	1	1

Baseline Characteristics

Phenylephrine in Spinal Anesthesia in Preeclamptic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phenylephrine n=54 Participants Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine n=54 Participants Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	54 Participants n=7 Participants	108 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 United States	54 participants n=5 Participants	54 participants n=7 Participants	108 participants n=5 Participants
Estimated gestational age (weeks)	36 weeks n=5 Participants	36 weeks n=7 Participants	36 weeks n=5 Participants
Multiple gestation	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Preeclampsia Mild preeclampsia	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Preeclampsia Severe preeclampsia	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Number of infants delivered per group	72 number of infants n=5 Participants	74 number of infants n=7 Participants	146 number of infants n=5 Participants
Baseline systolic blood pressure	150 mmHg n=5 Participants	146 mmHg n=7 Participants	148 mmHg n=5 Participants
Baseline heart rate	83 Number n=5 Participants	85 Number n=7 Participants	84 Number n=5 Participants
Body mass index	31 kg/m^2 n=5 Participants	33 kg/m^2 n=7 Participants	32 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Immediately after delivery

Population: 72 newborn blood samples in the phenylephrine group and 74 newborn blood samples were analyzed (there were multiple gestations in both groups)

Outcome measures

Outcome measures
Measure	Phenylephrine n=72 Newborn blood gas samples Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine n=74 Newborn blood gas samples Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
The Umbilical Artery pH	7.22 pH Standard Deviation .07	7.20 pH Standard Deviation .1

SECONDARY outcome

Timeframe: Immediately after delivery

Population: 72 newborn blood samples were obtained from the phenylephrine group and 74 newborn samples were obtained from the ephedrine group ( there were multiple gestations in both groups)

The umbilical artery blood base excess immediately after delivery. Base excess and base deficit refer to an excess or deficit, in the amount of base present in the blood. The value (-2 to +2 normal range) is usually reported as a concentration in units of mEq/L, with positive numbers indicating an excess of base and negative a deficit

Outcome measures

Outcome measures
Measure	Phenylephrine n=72 Newborn blood gas samples Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine n=74 Newborn blood gas samples Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
The Umbilical Artery Blood Base Excess	-2.8 mEq/L Interval -4.6 to -2.2	-3.4 mEq/L Interval -5.7 to -2.0

Adverse Events

Phenylephrine Mothers

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Ephedrine Mothers

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Phenylepherine Infants

Serious events: 27 serious events

Other events: 0 other events

Deaths: 0 deaths

Ephedrine Infants

Serious events: 25 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phenylephrine Mothers n=54 participants at risk Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine Mothers n=54 participants at risk Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Phenylepherine Infants n=72 participants at risk Infant of mother who received phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine Infants n=74 participants at risk Infant of mothers who received an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
Blood and lymphatic system disorders Fetal Hypoxia	0.00% 0/54 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/54 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	37.5% 27/72 • Number of events 27 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	33.8% 25/74 • Number of events 25 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.

Other adverse events

Other adverse events
Measure	Phenylephrine Mothers n=54 participants at risk Subject will receive a phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine Mothers n=54 participants at risk Subject will receive an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Phenylepherine Infants n=72 participants at risk Infant of mother who received phenylephrine infusion to prevent and to treat hypotension associated with spinal anesthesia Phenylephrine: Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.	Ephedrine Infants n=74 participants at risk Infant of mothers who received an ephedrine infusion to prevent and to treat hypotension associated with spinal anesthesia Ephedrine: Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP \> 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP \< 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
Vascular disorders Reactive hypertension	0.00% 0/54 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/54 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/72 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/74 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.
Cardiac disorders Bradycardia	0.00% 0/54 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	3.7% 2/54 • Number of events 2 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/72 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/74 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.
Gastrointestinal disorders Nausea	33.3% 18/54 • Number of events 18 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	40.7% 22/54 • Number of events 22 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/72 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/74 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.
Gastrointestinal disorders Vomiting	5.6% 3/54 • Number of events 3 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	7.4% 4/54 • Number of events 4 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/72 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.	0.00% 0/74 • Up to 3 hours after delivery. There were 54 women in each group (phenylephrine and ephedrine group). The women delivered 146 neonates (multiple gestations in each group) 72 neonates were delivered in the phenylephrine group and 74 neonates were delivered in the ephedrine group.

Additional Information

Paul Fitzgerald

Northwestern University

Phone: 312-6951064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place