N/A
Completed N=818
Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery
Source: ClinicalTrials.gov NCT00380978 ↗Enrolled (actual)
818
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Delivered by Cesarean Section — 134; 126 participants — p=0.65
Summary
The purpose of this study in nulliparous women undergoing induction of labor is to determine whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in labor (< 4 cm cervical dilation)affects the cesarean delivery rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delivered by Cesarean Section |
134; 126 | 0.65 |
| SECONDARY Instrumented Vaginal Delivery |
57; 59 | 0.63 |
| SECONDARY Duration of Labor |
528; 569 | 0.047 sig |
| SECONDARY Indication for Cesarean Delivery |
85; 83; 18; 23; 27; 16 | 0.35 |
| SECONDARY Analgesia Efficacy |
1; 5 | <0.005 sig |
| SECONDARY Nausea |
372; 265; 25; 69; 5; 49 | <0.005 sig |
| SECONDARY Neonatal Outcome (APGAR Score < 7 at 5 Minutes) |
14; 6 | 0.11 |
| SECONDARY Vomiting |
12; 61 | <0.005 sig |
Eligibility Criteria
Inclusion Criteria
- induction of labor
- nulliparity
- >36 weeks gestation
- singleton
- vertex position
- cervical dilation 4cm at analgesia request
- chronic opioid therapy
- acute opioid therapy within 4 hours of analgesia request
- allergy to study drugs (hydromorphone, fentanyl, bupivacaine, lidocaine)
Data sourced from ClinicalTrials.gov (NCT00380978). 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.