Trial Outcomes & Findings for The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery (NCT NCT00443560)
NCT ID: NCT00443560
Last Updated: 2014-04-14
Results Overview
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.
COMPLETED
2162 participants
Second stage of labor up to 3 hours
2014-04-14
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1081
|
1081
|
|
Overall Study
COMPLETED
|
1021
|
1051
|
|
Overall Study
NOT COMPLETED
|
60
|
30
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
No intrathecal dose
|
58
|
26
|
|
Overall Study
Multiple pregnancies or fetal demise
|
2
|
4
|
Baseline Characteristics
The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
Baseline characteristics by cohort
| Measure |
Instrumental Vaginal Delivery (IVD)
n=1081 Participants
Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
|
Spontaneous Vaginal Delivery (SVD)
n=1081 Participants
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.
|
Total
n=2162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1081 Participants
n=99 Participants
|
1081 Participants
n=107 Participants
|
2162 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 3 • n=99 Participants
|
31 years
STANDARD_DEVIATION 3 • n=107 Participants
|
31 years
STANDARD_DEVIATION 3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1081 Participants
n=99 Participants
|
1081 Participants
n=107 Participants
|
2162 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1081 participants
n=99 Participants
|
1081 participants
n=107 Participants
|
2162 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Second stage of labor up to 3 hoursPopulation: Analysis was per protocal
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.
Outcome measures
| Measure |
Instrumental Vaginal Delivery (IVD)
n=1021 Participants
Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
|
Spontaneous Vaginal Delivery (SVD)
n=1051 Participants
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.
|
|---|---|---|
|
Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor
|
146 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Supplemental analgesia in first stage of labor (<24 hours)Population: Analysis was per protocol
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.
Outcome measures
| Measure |
Instrumental Vaginal Delivery (IVD)
n=1021 Participants
Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
|
Spontaneous Vaginal Delivery (SVD)
n=1051 Participants
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.
|
|---|---|---|
|
Number of Participants With Breakthrough Pain in the First Stage of Labor
Supplemental bolus
|
802 participants
|
243 participants
|
|
Number of Participants With Breakthrough Pain in the First Stage of Labor
Infusion increase
|
149 participants
|
87 participants
|
|
Number of Participants With Breakthrough Pain in the First Stage of Labor
Concentration increase
|
32 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Time form initiation of labor analgesia to delivery (up to 24 hours)Population: Analysis was per protocal
Time in minutes from initiation of labor analgesia until delivery of the infant
Outcome measures
| Measure |
Instrumental Vaginal Delivery (IVD)
n=1021 Participants
Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
|
Spontaneous Vaginal Delivery (SVD)
n=1051 Participants
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.
|
|---|---|---|
|
Duration of Labor Analgesia
|
420 minutes
Interval 300.0 to 570.0
|
300 minutes
Interval 210.0 to 420.0
|
Adverse Events
Instrumental Vaginal Delivery (IVD)
Spontaneous Vaginal Delivery (SVD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert J. McCarthy, PharmD
Northwestern University Feinberg School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place