| September 25, 2006 |
| November 6, 2008 |
| October 2001 |
| September 2008 (final data collection date for primary outcome measure) |
| cesarean delivery rate [ Time Frame: Prospective: look forward using periodic observations collected predominantly following subject enrollment ] [ Designated as safety issue: Yes ] |
| cesarean delivery rate |
| Complete list of historical versions of study NCT00380978 on ClinicalTrials.gov Archive Site |
- type of vaginal delivery [ Designated as safety issue: Yes ]
- duration of labor [ Designated as safety issue: Yes ]
- indication for cesarean delivery [ Designated as safety issue: Yes ]
- analgesia efficacy
- analgesia side effects [ Designated as safety issue: Yes ]
- neonatal outcome [ Designated as safety issue: Yes ]
|
- type of vaginal delivery
- duration of labor
- indication for cesarean delivery
- analgesia efficacy
- analgesia side effects
- neonatal outcome
|
| |
| Neuraxial vs. Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery |
| Neuraxial vs. Systemic Analgesia for Latent Phase Labor Analgesia in Nulliparous Parturients With Induction of Labor: Effect on Rate of Operative Delivery |
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. |
Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) shot). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, and vomiting, and neonatal respiration depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural vs. IV/IM narcotic labor analgesia (not specifically 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 forceps delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial vs. IV/IM analgesia for early labor (cervical dilation < 4 cm). |
| |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Pregnancy |
| Procedure: combined spinal epidural analgesia |
| |
| Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, Yaghmour E, Marcus RJ, Sherwani SS, Sproviero MT, Yilmaz M, Patel R, Robles C, Grouper S. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med. 2005 Feb 17;352(7):655-65. |
| |
| Completed |
| 1600 |
| September 2008 |
| September 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- induction of labor, nulliparity, > 36 weeks gestation, single gestation, vertex position, cervical dilation < 4 cm at first request for analgesia, desires neuraxial analgesia
Exclusion Criteria:
- chronic opioid therapy, acute opioid therapy, allergy to study drugs (hydromorphone, fentanyl, bupivacaine, lidocaine)
|
| Female |
|
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00380978 |
| Cynthia A. Wong M.D., Northwestern University |
| 0524-009 |
| Northwestern University |
| International Anesthesia Research Society (IARS) |
| Principal Investigator: |
Cynthia A Wong, MD |
Northwestern University |
|
|
| Northwestern University |
| November 2008 |