Phase 4 Completed N=602 Randomized Quadruple-blind Prevention

Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

Postoperative Pain

Source: ClinicalTrials.gov NCT02062801 ↗

Enrolled (actual)

602

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcomePrimary: Early Profound Fetal Bradycardia — 8; 14 participants — p=0.18

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Early Profound Fetal Bradycardia	8; 14	0.18
SECONDARY Tetanic (Sustained) Uterine Contraction (TUC)	58; 58	0.97
SECONDARY Urgent Cesarean Delivery	1; 2	.56

Eligibility Criteria

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 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

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Data sourced from ClinicalTrials.gov (NCT02062801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.