NCT00119184

Brief Summary

The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus. Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful. The main outcome is success of ECV.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 28, 2017

Status Verified

May 1, 2008

Enrollment Period

3.4 years

First QC Date

July 3, 2005

Last Update Submit

November 26, 2017

Conditions

Breech Presentation

Keywords

anesthesiabreechexternal cephalic versionspinalsuccessanesthesia,spinal

Outcome Measures

Primary Outcomes (1)

  • Conversion of a breech to a vertex presentation

    4-6 years

Secondary Outcomes (4)

  • Complications associated with ECV: Premature rupture of membranes, Contractions, Placental abruption, Fetal distress, Pain score during procedure (VAS Scale 0 = no pain, 10 = severe pain).

    4-6 years

  • Complications associated with analgesia: Severe maternal hypotension (>20 reduction in systolic BP), Fetal distress (prior to performance of ECV), Post Dural Puncture Headache, Failure of analgesia.

    4-6 years

  • Inability to perform procedure due to maternal distress or discomfort.

    4-6 years

  • Mode of delivery and date from the ECV.

    4-6 years

Study Arms (2)

External cephalic version with spinal anesthesia

EXPERIMENTAL

External cephalic version with spinal anesthesia

Procedure: External cephalic versionDrug: spinal anesthesia

External cephalic version without spinal anesthesia

ACTIVE COMPARATOR

External cephalic version without spinal anesthesia

Procedure: External cephalic version

Interventions

External cephalic versionPROCEDURE

7.5 mg bupivacaine intrathecally

External cephalic version with spinal anesthesiaExternal cephalic version without spinal anesthesia
spinal anesthesiaDRUG

spinal anesthesia

External cephalic version with spinal anesthesia

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II
  • + weeks gestation
  • No previous attempt at ECV in this pregnancy
  • No fetal abnormality

You may not qualify if:

  • No previous uterine surgery
  • Any contraindication for vaginal delivery
  • Contra-indications to regional analgesia: uncorrected hypovolemia, coagulopathy (including anti-coagulants but not low-dose \[100mg\] aspirin), infection or inflammation of the skin overlying the lumbar area, raised intra-cranial pressure, hypersensitivity to amide local anesthetic agents.
  • Patient refusal for regional analgesia
  • Previous history of meningitis, neuropathy, or severe back pain with neurological radiation
  • Poor communication (no Hebrew or English spoken, deafness, blindness, serious intellectual impairment or psychiatric disorder)
  • Morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 12000, Israel

Location

Related Publications (2)

  • Weiniger CF, Ginosar Y, Elchalal U, Sela HY, Weissman C, Ezra Y. Randomized controlled trial of external cephalic version in term multiparae with or without spinal analgesia. Br J Anaesth. 2010 May;104(5):613-8. doi: 10.1093/bja/aeq053. Epub 2010 Mar 25.

    PMID: 20338954DERIVED

  • Weiniger CF, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. doi: 10.1097/01.AOG.0000295605.38175.7b.

    PMID: 18055730DERIVED

MeSH Terms

Conditions

Breech Presentation

Interventions

Version, FetalAnesthesia, Spinal

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativeAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Carolyn F Weiniger, MB ChB

    Dept Anesthesiology, Hadassah Hebrew University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2005

First Posted

July 13, 2005

Study Start

October 1, 2002

Primary Completion

March 1, 2006

Study Completion

May 1, 2008

Last Updated

November 28, 2017

Record last verified: 2008-05

Locations

IL(1)