Labor Pain, Pregnancy
Conditions
Keywords
Labor, Epidural Analgesia, delivery, vacuum extraction, obstetrical Forceps
Brief 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.
Detailed description
The obstetrical anesthesia database will be queried for all forceps deliveries between the dates of January 2004-October 2005. To minimize the influence of different anesthetic and obstetric care providers, the control group consisted of parturients who has spontaneous vaginal deliveries (SVD) in the same 24 hour period who were case-matched for gravidity and parity. Parturients with twin deliveries and fetal demise were not selected for either group. The database will be queried for the following: maternal age, parity, gestational age, type of analgesia, changes in epidural infusion rate and/or concentration, and supplemental bolus doses of local anesthesia. The data will be stripped of identification by the database manager and entered into a secured computer which is password protected and maintained in the Department of Anesthesiology. The primary endpoint is to evaluate if decreasing the epidural infusion rate was associated with a forceps delivery.
Interventions
OTHERCase controlled analysis of epidural labor analgesia patterns
A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
Sponsors
Northwestern University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Singletons * Viable fetal vaginal deliveries between January 2004-October 2005
Exclusion criteria
* Outside specified time frame * Multiparity * Fetal demise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor | Second stage of labor up to 3 hours | At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Breakthrough Pain in the First Stage of Labor | Supplemental analgesia in first stage of labor (<24 hours) | Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced. |
| Duration of Labor Analgesia | Time form initiation of labor analgesia to delivery (up to 24 hours) | Time in minutes from initiation of labor analgesia until delivery of the infant |
Countries
United States
Participant flow
Recruitment details
The Obstetric Anesthesiology Database was used to identify parturients from the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital who qualified for the study between January 2004 and October 2005.
Participants by arm
| Arm | Count |
|---|---|
| Instrumental Vaginal Delivery (IVD) Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions. | 1,081 |
| Spontaneous Vaginal Delivery (SVD) The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity. | 1,081 |
| Total | 2,162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Multiple pregnancies or fetal demise | 2 | 4 |
| Overall Study | No intrathecal dose | 58 | 26 |
Baseline characteristics
| Characteristic | Spontaneous Vaginal Delivery (SVD) | Instrumental Vaginal Delivery (IVD) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1081 Participants | 1081 Participants | 2162 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 3 | 32 years STANDARD_DEVIATION 3 | 31 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 1081 participants | 1081 participants | 2162 participants |
| Sex: Female, Male Female | 1081 Participants | 1081 Participants | 2162 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor
At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued.
Time frame: Second stage of labor up to 3 hours
Population: Analysis was per protocal
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Instrumental Vaginal Delivery (IVD) | Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor | 146 participants |
| Spontaneous Vaginal Delivery (SVD) | Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor | 51 participants |
p-value: <0.0195% CI: [2.3, 4.5]Chi-squared, Corrected
Secondary
Duration of Labor Analgesia
Time in minutes from initiation of labor analgesia until delivery of the infant
Time frame: Time form initiation of labor analgesia to delivery (up to 24 hours)
Population: Analysis was per protocal
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Instrumental Vaginal Delivery (IVD) | Duration of Labor Analgesia | 420 minutes |
| Spontaneous Vaginal Delivery (SVD) | Duration of Labor Analgesia | 300 minutes |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Breakthrough Pain in the First Stage of Labor
Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced.
Time frame: Supplemental analgesia in first stage of labor (<24 hours)
Population: Analysis was per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Instrumental Vaginal Delivery (IVD) | Number of Participants With Breakthrough Pain in the First Stage of Labor | Concentration increase | 32 participants |
| Instrumental Vaginal Delivery (IVD) | Number of Participants With Breakthrough Pain in the First Stage of Labor | Infusion increase | 149 participants |
| Instrumental Vaginal Delivery (IVD) | Number of Participants With Breakthrough Pain in the First Stage of Labor | Supplemental bolus | 802 participants |
| Spontaneous Vaginal Delivery (SVD) | Number of Participants With Breakthrough Pain in the First Stage of Labor | Infusion increase | 87 participants |
| Spontaneous Vaginal Delivery (SVD) | Number of Participants With Breakthrough Pain in the First Stage of Labor | Supplemental bolus | 243 participants |
| Spontaneous Vaginal Delivery (SVD) | Number of Participants With Breakthrough Pain in the First Stage of Labor | Concentration increase | 19 participants |
p-value: <0.0195% CI: [9.9, 15]Chi-squared, Corrected