Phase 4
Completed N=228
Epidural Morphine Following Vaginal Delivery
Source: ClinicalTrials.gov NCT00803114 ↗Enrolled (actual)
228
Serious AEs
—
Results posted
Dec 2008
Primary outcomePrimary: The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum — 8; 37 participants — p=0.05
Summary
The investigators believe that pain management following a vaginal delivery can be improved. Many women receive epidural medication during labor and delivery, and the investigators felt that using the epidural following delivery might improve the first day pain. This study is to determine whether a single dose of epidural morphine given to mothers after a vaginal delivery will reduce the perineal pain in the postpartum period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum |
8; 37 | 0.05 |
| SECONDARY Time to First Request for Analgesia |
22.9; 18.9 | 0.05 |
| SECONDARY Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic |
0.3; 1.6 | 0.05 |
| SECONDARY Maternal Satisfaction With Perineal Pain Management |
1; 3; 9; 11; 6; 8 | 0.80 |
| SECONDARY Side Effects |
— | — |
Eligibility Criteria
Inclusion Criteria
- Healthy parturients (ASA 1 or 2) of > 34 weeks gestational age who chose epidural analgesia for labor, and deliver vaginally.
Exclusion Criteria
- Women whose labor is terminated by cesarean delivery
- Parturients with known morphine allergy
- Parturients with narcotic addiction past / present
Data sourced from ClinicalTrials.gov (NCT00803114). 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. Informational only — not medical advice.