Phase 4
N=602
Prophylactic Ephedrine and Combined Spinal Epidurals for Labor
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT02062801 ↗Enrolled (actual)
602
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Early Profound Fetal Bradycardia — 8; 14 participants — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ephedrine (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Sharp HealthCare
- Primary completion
- Apr 2013
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 |
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.
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
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.