Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

Completed · Phase 4 · Has a placebo group

Conditions studied: Labor Pain

In brief

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.

Key facts

Study ID

NCT02062801

Run by

Sharp HealthCare

People needed

710

Starts

2012-01-01

Expected to finish

2013-10-01

Last updated by the study team

2015-07-03

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States

Full record on ClinicalTrials.gov

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