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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
International Anesthesia Research Society (IARS) |
| Information provided by (Responsible Party): | Cynthia Wong, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00380978 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Labor Pain Pregnancy |
Procedure: combined spinal epidural analgesia Procedure: late analgesia (systemic) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Compared With Late Neuraxial Analgesia in Nulliparous Labor Induction |
| Enrollment: | 1026 |
| Study Start Date: | October 2001 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: early analgesia:combined-spinal epidural |
Procedure: combined spinal epidural analgesia
Analgesia was initiated in the early group using a standard needle-through-needle technique with intrathecal fentanyl 25 mcg and an epidural test dose of lidocaine 15 mg/ml and epinephrine 5 mcg/ml in 3ml. At the second analgesia request, the cervix was examined. Epidural analgesia was initiated with a dilute bupivicaine/fentanyl solution if the cervix was less than 4 cm. If the cervix was 4 cm or more, epidural analgesia was initiated with bupivicaine 1.25 mg/ml. If no cervical exam was performed at the second request for analgesia, the cervix was assumed to be at least 4 cm dilated. Thereafter, analgesia was maintained in all participants in the early group with patient-controlled epidural analgesia.
Other Name: CSE
|
| Active Comparator: late analgesia (systemic) |
Procedure: late analgesia (systemic)
Analgesia was initiated in the late group with hydromorphone 1mg intramuscularly (IM) and 1 mg intravenously (IV). If the cervix was less than 4 cm at the second analgesia request, hydromorphone analgesia was repeated. Epidural analgesia was initiated with bupivicaine 1.25 mg/ml if the cervix was 4 cm or more. At the third analgesia request, epidural analgesia was initiated regardless of cervical dilation. Thereafter, epidural analgesia was maintained with patient controlled analgesia until delivery.
Other Name: Dilaudid, narcotic
|
Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) injection). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, vomiting, and neonatal respiratory depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural versus IV/IM narcotic labor analgesia (not specifically in early labor)suggest that initiation of early neuraxial analgesia may be associated with higher Cesarean delivery rates. It has been hypothesized that epidural/spinal local anesthetics may induce pelvic musculature relaxation leading to failure of fetal descent and rotation. However, early pain may be a marker for other factors that increase the risk of Cesarean delivery, e.g., large or malpositioned baby, or dysfunctional labor. Whether or not early neuraxial analgesia (particularly if narcotic based, which would not cause pelvic muscle paralysis) compared to IV/IM narcotics, adversely affects the outcome of labor has not been studied in a randomized, prospective fashion. The purpose of this study is to compare Cesarean and forcep delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial versus IV/IM analgesia for early labor (cervical dilation < 4 cm).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Cynthia A Wong, MD | Northwestern University |
More Information
| Responsible Party: | Cynthia Wong, Professor of Anesthesiology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00380978 History of Changes |
| Other Study ID Numbers: | 0524-009 |
| Study First Received: | September 25, 2006 |
| Results First Received: | July 5, 2011 |
| Last Updated: | November 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
labor pain cesarean section epidural analgesia |
opioid analgesics local anesthetics labor induced |
|
Labor Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |