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Prophylactic Ephedrine and Combined Spinal Epidurals for Labor (CEASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02062801
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Information provided by (Responsible Party):
David Gambling, M.D., Sharp HealthCare

Brief Summary:
The combined spinal epidural (CSE) technique has become increasingly popular for labor pain because of its rapid onset and superior first stage analgesia. However, increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of CSE administration during labor. The purpose of this study is to measure the incidence of EPFB after combined spinal epidural analgesia using standard definitions. The incidence of EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the time of CSE placement.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: Ephedrine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Ephedrine to Reduce Fetal Bradycardia After Combined Spinal Epidural Labor Analgesia: a Randomized Double Blind Placebo-controlled Study
Study Start Date : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Active Comparator: Prophylactic ephedrine
Ephedrine 10mg iv once at time of combined spinal epidural insertion
Drug: 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

Placebo Comparator: Normal saline (placebo) control group
1ml normal saline intravenously once at time of combined spinal epidural insertion
Drug: Placebo
Patients received normal saline (placebo) administered immediately after combined spinal epidural (CSE) placement

Primary Outcome Measures :
  1. Early Profound Fetal Bradycardia [ Time Frame: Within 30 minutes of combined spinal epidural (CSE) placement ]
    Incidence of early profound fetal bradycardia

Secondary Outcome Measures :
  1. Tetanic (Sustained) Uterine Contraction (TUC) [ Time Frame: Within 30 minutes of combined spinal epidural (CSE) placement ]
    Incidence of Tetanic (sustained) Uterine Contraction (TUC)

  2. Urgent Cesarean Delivery [ Time Frame: Within 30 minutes of combined spinal epidural (CSE) placement ]
    Incidence of urgent cesarean delivery

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Ability to speak and understand English
  • Term (37-42 weeks' gestation)
  • Cephalic presentation
  • Singleton pregnancy
  • ASA 3 or less
  • No pregnancy-induced hypertension
  • No chronic hypertension
  • BMI <40
  • No evidence of pre-epidural fetal heart rate abnormality
  • No IUGR or low AFI. ASA 1-3 women who request epidural analgesia Informed consent signed upon admission to L&D

Exclusion Criteria:

  • ASA 4 women, BMI > 39
  • Contraindication to epidural analgesia
  • Twin pregnancy
  • Preterm labor
  • Severe preeclampsia
  • Decision to perform CS prior to epidural insertion
  • Unable to read or speak English
  • Unable or unwilling to sign the IFC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02062801

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United States, California
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
Sponsors and Collaborators
Sharp HealthCare
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Principal Investigator: David R Gambling, MB,BS Anesthesia Services Medical Group
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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Gambling, M.D., Medical Director, Surgical Services, Sharp HealthCare Identifier: NCT02062801    
Other Study ID Numbers: CEASE111199
First Posted: February 14, 2014    Key Record Dates
Results First Posted: July 3, 2015
Last Update Posted: July 3, 2015
Last Verified: June 2015
Keywords provided by David Gambling, M.D., Sharp HealthCare:
Combined spinal epidural analgesia, labor, fetal bradycardia
Additional relevant MeSH terms:
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Labor Pain
Neurologic Manifestations
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action