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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

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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

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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.

ListOutcomeTime frameDescription
PrimarySuccess Rate of External Cephalic VersionCompletion of the procedureRates of successful version evaluated among the 4 dose groups.
SecondaryMode of DeliveryTo time of delivery
SecondaryIndication of Cesarean DeliveryTo time of delivery
SecondaryPain Score During the Procedure< 20 minutespain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale)
SecondaryAbdominal Relaxation<20 minutesObstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100)

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYSuccess Rate of External Cephalic VersionCompletion of the procedureParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMode of DeliveryTo time of deliverycount of participantsNUMBER
SECONDARYIndication of Cesarean DeliveryTo time of deliveryParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPain Score During the Procedure< 20 minutesunits on a scaleMEDIAN
SECONDARYAbdominal Relaxation<20 minutesunits on a scaleMEDIAN

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Success Rate of External Cephalic VersionDrug:Group 2.531Participants
Success Rate of External Cephalic VersionGroup 531Participants
Success Rate of External Cephalic VersionGroup 7.531Participants
Success Rate of External Cephalic VersionGroup 1030Participants
Mode of DeliveryDrug:Group 2.5Vaginal26count of participants
Mode of DeliveryGroup 5Vaginal23count of participants
Mode of DeliveryGroup 7.5Vaginal28count of participants
Mode of DeliveryGroup 10Vaginal24count of participants
Mode of DeliveryDrug:Group 2.5Cesarean34count of participants
Mode of DeliveryGroup 5Cesarean37count of participants

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDDrug:Group 2.560
Overall StudySTARTEDGroup 560
Overall StudySTARTEDGroup 7.560
Overall StudySTARTEDGroup 1060
Overall StudyCOMPLETEDDrug:Group 2.560
Overall StudyCOMPLETEDGroup 560
Overall StudyCOMPLETEDGroup 7.559
Overall StudyCOMPLETEDGroup 1060
Overall StudyNOT COMPLETEDDrug:Group 2.50
Overall StudyNOT COMPLETEDGroup 50

Adverse 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.

TotalGroupAffectedAt risk
Total, all-cause mortalityGroup 2.5060
Total, all-cause mortalityGroup 5060
Total, all-cause mortalityGroup 7.5059
Total, all-cause mortalityGroup 10060
Total, other adverse eventsGroup 2.5060
Total, other adverse eventsGroup 5060
Total, other adverse eventsGroup 7.5060
Total, other adverse eventsGroup 10060
Total, serious adverse eventsGroup 2.5060
Total, serious adverse eventsGroup 5060

Papers11

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
3288930BACKGROUNDPubMed
8067558BACKGROUNDPubMed
8336883BACKGROUNDPubMed
9359456BACKGROUNDPubMed
9396908BACKGROUNDPubMed
10074976BACKGROUNDPubMed
10775722BACKGROUNDPubMed
11473871BACKGROUNDPubMed
12076384BACKGROUNDPubMed
19682886BACKGROUNDPubMed

1 to 10 of 11

See all 11 papers

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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