N/A
N=240
A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version
Pregnancy · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01991743 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Success Rate of External Cephalic Version — 31; 31; 31; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group 2.5 (Drug); Group 5 (Drug); Group 7.5 (Drug); Group 10 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate of External Cephalic Version |
31; 31; 31; 30 | — |
| SECONDARY Mode of Delivery |
26; 23; 28; 24; 34; 37 | — |
| SECONDARY Indication of Cesarean Delivery |
27; 26; 25; 25; 4; 4 | — |
| SECONDARY Pain Score During the Procedure |
12; 5; 4; 4 | — |
| SECONDARY Abdominal Relaxation |
78; 83; 84; 88 | — |
Summary
We plan to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction during, external version for breech fetal position and the incidence of vaginal vs. Cesarean delivery.
The research aim of this project is to determine the ideal neuraxial dosing strategy to maximize success of external cephalic version (ECV).
The research questions, does a combined spinal-epidural (CSE) of a higher dose result in greater success in converting a breech presentation to vertex during external cephalic version (ECV).
The hypotheses of this project is that CSE at higher dose will result in greater ECV success than analgesic dosing.
The research significance:Increasing the success and comfort of ECV for fetal malpresentation may help decrease the cesarean section rate.
Eligibility Criteria
Inclusion Criteria
- Healthy patients age 18 and older
- Breech presentation
- Singleton gestation .scheduled for ECV desiring CSE.
Exclusion Criteria
- Refusal
- Contraindication to neuraxial (coagulopathy, anticoagulant use, local infection, sepsis etc) .Rupture of membranes.
- Drop-out: Patients may choose to drop-out of the study at any time. The physicians involved in this study may choose to end a patient's involvement in the study at their discretion.
Data sourced from ClinicalTrials.gov (NCT01991743). 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.