Trial · NCT01991743
A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version
NCT01991743, Not applicable, Completed, Northwestern University; results first posted 2020-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version. Trials, record NCT01991743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01991743
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version
- NCT number
- NCT01991743
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 240 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Pregnancy, Pain
- Interventions
- Group 2.5, Group 5, Group 7.5, Group 10
- First posted
- 2013-11-25
- Last updated
- 2020-01-06
- Results first posted
- 2020-01-06
- Limitations and caveats
The limitations include group allocation concealment and lack of a control group. The obstetrician's assessment of success, pain, anxiety, and fetus status may have prejudiced the decision to proceed or persist with external cephalic version.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rate of External Cephalic Version | Completion of the procedure | Rates of successful version evaluated among the 4 dose groups. |
| Secondary | Mode of Delivery | To time of delivery | |
| Secondary | Indication of Cesarean Delivery | To time of delivery | |
| Secondary | Pain Score During the Procedure | < 20 minutes | pain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale) |
| Secondary | Abdominal Relaxation | <20 minutes | Obstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Success Rate of External Cephalic Version | Completion of the procedure | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mode of Delivery | To time of delivery | count of participants | NUMBER | |
| SECONDARY | Indication of Cesarean Delivery | To time of delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pain Score During the Procedure | < 20 minutes | units on a scale | MEDIAN | |
| SECONDARY | Abdominal Relaxation | <20 minutes | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Success Rate of External Cephalic Version | Drug:Group 2.5 | 31 | Participants | ||
| Success Rate of External Cephalic Version | Group 5 | 31 | Participants | ||
| Success Rate of External Cephalic Version | Group 7.5 | 31 | Participants | ||
| Success Rate of External Cephalic Version | Group 10 | 30 | Participants | ||
| Mode of Delivery | Drug:Group 2.5 | Vaginal | 26 | count of participants | |
| Mode of Delivery | Group 5 | Vaginal | 23 | count of participants | |
| Mode of Delivery | Group 7.5 | Vaginal | 28 | count of participants | |
| Mode of Delivery | Group 10 | Vaginal | 24 | count of participants | |
| Mode of Delivery | Drug:Group 2.5 | Cesarean | 34 | count of participants | |
| Mode of Delivery | Group 5 | Cesarean | 37 | count of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Drug:Group 2.5 | 60 | |
| Overall Study | STARTED | Group 5 | 60 | |
| Overall Study | STARTED | Group 7.5 | 60 | |
| Overall Study | STARTED | Group 10 | 60 | |
| Overall Study | COMPLETED | Drug:Group 2.5 | 60 | |
| Overall Study | COMPLETED | Group 5 | 60 | |
| Overall Study | COMPLETED | Group 7.5 | 59 | |
| Overall Study | COMPLETED | Group 10 | 60 | |
| Overall Study | NOT COMPLETED | Drug:Group 2.5 | 0 | |
| Overall Study | NOT COMPLETED | Group 5 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 2.5 | 0 | 60 |
| Total, all-cause mortality | Group 5 | 0 | 60 |
| Total, all-cause mortality | Group 7.5 | 0 | 59 |
| Total, all-cause mortality | Group 10 | 0 | 60 |
| Total, other adverse events | Group 2.5 | 0 | 60 |
| Total, other adverse events | Group 5 | 0 | 60 |
| Total, other adverse events | Group 7.5 | 0 | 60 |
| Total, other adverse events | Group 10 | 0 | 60 |
| Total, serious adverse events | Group 2.5 | 0 | 60 |
| Total, serious adverse events | Group 5 | 0 | 60 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01991743
GET https://conductscience.org/api/trials/v1/NCT01991743/results?page=2