Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

NCT02062801 | Completed Phase 4 Results

• 1 other identifier: CEASE111199
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Combined spinal epidural analgesia, labor, fetal bradycardia

Outcome Measures

Primary Outcomes (1)

• Early Profound Fetal Bradycardia

  Incidence of early profound fetal bradycardia

  Within 30 minutes of combined spinal epidural (CSE) placement

Secondary Outcomes (2)

• Tetanic (Sustained) Uterine Contraction (TUC)

  Within 30 minutes of combined spinal epidural (CSE) placement

• Urgent Cesarean Delivery

  Within 30 minutes of combined spinal epidural (CSE) placement

Study Arms (2)

Prophylactic ephedrine

ACTIVE COMPARATOR

Ephedrine 10mg iv once at time of combined spinal epidural insertion

Drug: Ephedrine

Normal saline (placebo) control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ephedrine DRUG

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

Prophylactic ephedrine

Placebo DRUG

Patients received normal saline (placebo) administered immediately after combined spinal epidural (CSE) placement

Normal saline (placebo) control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharp HealthCare: lead

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• Gambling DR, Bender M, Faron S, Glaser D, Farrell TR. Prophylactic intravenous ephedrine to minimize fetal bradycardia after combined spinal-epidural labour analgesia: a randomized controlled study. Can J Anaesth. 2015 Nov;62(11):1201-8. doi: 10.1007/s12630-015-0450-8. Epub 2015 Aug 14.

  PMID: 26272720 DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Ephedrine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Dr. David R. Gambling
• Organization: Sharp HealthCare

david.gambling@sharp.com

858-395-5668

Study Officials

• David R Gambling, MB,BS

  Anesthesia Services Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Surgical Services

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 14, 2014
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 3, 2015
• Results First Posted: July 3, 2015

Record last verified: 2015-06

Locations

US (1)