N/A
N=2,162
The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
Labor Pain · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00443560 ↗Enrolled (actual)
2,162
Serious AEs
—
Results posted
Jul 2011
Primary outcome: Primary: Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor — 146; 51 participants — p=<0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Case controlled analysis of epidural labor analgesia patterns (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor |
146; 51 | <0.01 sig |
| SECONDARY Number of Participants With Breakthrough Pain in the First Stage of Labor |
802; 243; 149; 87; 32; 19 | <0.01 sig |
| SECONDARY Duration of Labor Analgesia |
420; 300 | <0.01 sig |
Summary
The objective of this study will be to compare epidural infusion management, specifically looking at infusion rate changes, in patients who receive forceps deliveries versus normal spontaneous vaginal deliveries. We will match patients based on time and date of delivery, as well as parity, in order to eliminate these variables as potential con-founders.
We hypothesize patients who require a decrease in their basal labor analgesia epidural infusion rate will have an increased incidence of forceps delivery.
Eligibility Criteria
Inclusion Criteria
- Singletons
- Viable fetal vaginal deliveries between January 2004-October 2005
Exclusion Criteria
- Outside specified time frame
- Multiparity
- Fetal demise
Data sourced from ClinicalTrials.gov (NCT00443560). 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.