Phase 4
N=43
Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)
Labor Pain · Complications; Cesarean Section · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02105558 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Vaginal Birth After Cesarean (VBAC) — 12; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Epidural anesthesia (Drug); Combined spinal and epidural anesthesia (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Vaginal Birth After Cesarean (VBAC) |
12; 22 | — |
| SECONDARY Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) |
3.5; 2.53 | — |
| SECONDARY Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) |
3.5; 2.53 | — |
| SECONDARY Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) |
3.5; 2.53 | — |
| SECONDARY Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) |
3.5; 2.53 | — |
| SECONDARY Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) |
3.5; 2.53 | — |
| SECONDARY Childbirth Experience as Assessed by a Visual Analogue Scale (VAS) |
8.25; 9.25 | — |
| SECONDARY Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS) |
8.42; 9.25 | — |
| SECONDARY Neonatal Outcome as Assessed by (APGAR) Score |
8.93; 9.04 | — |
| SECONDARY Neonatal Outcome as Assessed by (APGAR) Score |
8.93; 9.04 | — |
| SECONDARY Time From Regional Anesthesia to Delivery |
415.7; 454.5 | — |
| SECONDARY Time From Second Stage of Labor to Delivery |
71.25; 42.57 | — |
Summary
To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on the success of Trial of Labor After Cesarean (TOLAC).
Eligibility Criteria
Inclusion Criteria
- all patients meeting ACOG guidelines for TOLAC
- at least one previous elective cesarean delivery
- 40
- associated comorbidities such as gestational diabetes, preeclampsia, abnormal placentation
Data sourced from ClinicalTrials.gov (NCT02105558). 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.