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Trial record 12 of 535 for:    decongestants

Prophylactic Ephedrine and Combined Spinal Epidurals for Labor (CEASE)

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ClinicalTrials.gov Identifier: NCT02062801
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
David Gambling, M.D., Sharp HealthCare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Labor Pain
Interventions Drug: Ephedrine
Drug: Placebo
Enrollment 710
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Prophylactic Ephedrine Normal Saline Control Group
Hide Arm/Group Description

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

1ml normal saline intravenously once at time of combined spinal epidural insertion

Placebo

Period Title: Overall Study
Started 301 301
Completed 299 297
Not Completed 2 4
Arm/Group Title Prophylactic Ephedrine Normal Saline Control Group Total
Hide Arm/Group Description

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

1ml normal saline intravenously once at time of combined spinal epidural insertion

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 299 297 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 299 participants 297 participants 596 participants
29  (6) 30  (5) 30  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 297 participants 596 participants
Female
299
 100.0%
297
 100.0%
596
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Early Profound Fetal Bradycardia
Hide Description Incidence of early profound fetal bradycardia
Time Frame Within 30 minutes of combined spinal epidural (CSE) placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prophylactic Ephedrine Normal Saline Control Group
Hide Arm/Group Description:

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

1ml normal saline intravenously once at time of combined spinal epidural insertion

Placebo

Overall Number of Participants Analyzed 299 297
Measure Type: Number
Unit of Measure: participants
8 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prophylactic Ephedrine, Normal Saline Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Tetanic (Sustained) Uterine Contraction (TUC)
Hide Description Incidence of Tetanic (sustained) Uterine Contraction (TUC)
Time Frame Within 30 minutes of combined spinal epidural (CSE) placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prophylactic Ephedrine Normal Saline Control Group
Hide Arm/Group Description:

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

1ml normal saline intravenously once at time of combined spinal epidural insertion

Placebo

Overall Number of Participants Analyzed 299 297
Measure Type: Number
Unit of Measure: participants
58 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prophylactic Ephedrine, Normal Saline Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Urgent Cesarean Delivery
Hide Description Incidence of urgent cesarean delivery
Time Frame Within 30 minutes of combined spinal epidural (CSE) placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prophylactic Ephedrine Normal Saline Control Group
Hide Arm/Group Description:

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

1ml normal saline intravenously once at time of combined spinal epidural insertion

Placebo

Overall Number of Participants Analyzed 299 297
Measure Type: Number
Unit of Measure: participants
1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prophylactic Ephedrine, Normal Saline Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .56
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prophylactic Ephedrine Normal Saline Control Group
Hide Arm/Group Description

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

1ml normal saline intravenously once at time of combined spinal epidural insertion

Placebo

All-Cause Mortality
Prophylactic Ephedrine Normal Saline Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Prophylactic Ephedrine Normal Saline Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/301 (0.00%)   0/301 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prophylactic Ephedrine Normal Saline Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/301 (0.00%)   0/301 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. David R. Gambling
Organization: Sharp HealthCare
Phone: 858-395-5668
Publications:
1. Gambling DR et al.A randomized study of combined spinal-epidural analgesia versus intravenous meperidine during labor. Anesthesiology 1998; 89: 1336-44. 2. Mardirosoff C et al. Fetal bradycardia due to intrathecal opioids for labour analgesia : a systematic review. BJOG 2002; 109: 274-81. 3.Wright RG et al: The effect of maternal administration of ephedrine on fetal heart rate and variability. Obstet Gynecol.1981; 57: 734-8. 4.Tong C, Eisenach JC: The vascular mechanism of ephedrine's beneficial effect on uterine perfusion during pregnancy. Anesthesiology 1992; 76: 792-8 5.Reidy J, Douglas J: Vasopressors in obstetrics. Anesthesiol Clin. 2008 ;26:75-88, vi- vii. Review. 6. Gambling DR, McLaughlin KR. Ephedrine and phenylephrine use during cesarean delivery. Anesthesiology 2010; 112: 1287-8. 7. Kreiser D et al. The effect of ephedrine on intrapartum fetal heart rate after epidural analgesia. Obstet Gynecol. 2004;104:1277-81. 8. Cleary-Goldman J et al.. Prophylactic ephedrine and combined spinal epidural: maternal blood pressure and fetal heart rate patterns. Obstet Gynecol. 2005; 106: 466-72.
Responsible Party: David Gambling, M.D., Sharp HealthCare
ClinicalTrials.gov Identifier: NCT02062801     History of Changes
Other Study ID Numbers: CEASE111199
First Submitted: February 7, 2014
First Posted: February 14, 2014
Results First Submitted: May 28, 2015
Results First Posted: July 3, 2015
Last Update Posted: July 3, 2015