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Trial Outcomes & Findings for Prophylactic Ephedrine and Combined Spinal Epidurals for Labor (NCT NCT02062801)

NCT ID: NCT02062801

Last Updated: 2015-07-03

Results Overview

Incidence of early profound fetal bradycardia

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

710 participants

Primary outcome timeframe

Within 30 minutes of combined spinal epidural (CSE) placement

Results posted on

2015-07-03

Participant Flow

A total of 710 participants met criteria for eligibility in the study. Of that total, 108 declined to participate in the study, and were excluded prior to random group assignment. This resulted in 602 total participants (301 for each of the intervention groups).

Participant milestones

Participant milestones
Measure
Prophylactic Ephedrine
Ephedrine 10mg iv once at time of combined spinal epidural insertion Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (\<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
Normal Saline Control Group
1ml normal saline intravenously once at time of combined spinal epidural insertion Placebo
Overall Study
STARTED
301
301
Overall Study
COMPLETED
299
297
Overall Study
NOT COMPLETED
2
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Prophylactic Ephedrine
n=299 Participants
Ephedrine 10mg iv once at time of combined spinal epidural insertion Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (\<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
Normal Saline Control Group
n=297 Participants
1ml normal saline intravenously once at time of combined spinal epidural insertion Placebo
Total
n=596 Participants
Total of all reporting groups
Age, Continuous
29 years
STANDARD_DEVIATION 6 • n=99 Participants
30 years
STANDARD_DEVIATION 5 • n=107 Participants
30 years
STANDARD_DEVIATION 5 • n=206 Participants
Sex: Female, Male
Female
299 Participants
n=99 Participants
297 Participants
n=107 Participants
596 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Within 30 minutes of combined spinal epidural (CSE) placement

Incidence of early profound fetal bradycardia

Outcome measures

Outcome measures
Measure
Prophylactic Ephedrine
n=299 Participants
Ephedrine 10mg iv once at time of combined spinal epidural insertion Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (\<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
Normal Saline Control Group
n=297 Participants
1ml normal saline intravenously once at time of combined spinal epidural insertion Placebo
Early Profound Fetal Bradycardia
8 participants
14 participants

SECONDARY outcome

Timeframe: Within 30 minutes of combined spinal epidural (CSE) placement

Incidence of Tetanic (sustained) Uterine Contraction (TUC)

Outcome measures

Outcome measures
Measure
Prophylactic Ephedrine
n=299 Participants
Ephedrine 10mg iv once at time of combined spinal epidural insertion Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (\<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
Normal Saline Control Group
n=297 Participants
1ml normal saline intravenously once at time of combined spinal epidural insertion Placebo
Tetanic (Sustained) Uterine Contraction (TUC)
58 participants
58 participants

SECONDARY outcome

Timeframe: Within 30 minutes of combined spinal epidural (CSE) placement

Incidence of urgent cesarean delivery

Outcome measures

Outcome measures
Measure
Prophylactic Ephedrine
n=299 Participants
Ephedrine 10mg iv once at time of combined spinal epidural insertion Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (\<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
Normal Saline Control Group
n=297 Participants
1ml normal saline intravenously once at time of combined spinal epidural insertion Placebo
Urgent Cesarean Delivery
1 participants
2 participants

Adverse Events

Prophylactic Ephedrine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Normal Saline Control 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. David R. Gambling

Sharp HealthCare

Phone: 858-395-5668

Results disclosure agreements

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