Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version

This study has been terminated.

( Multiparas study terminated due to poor recruitment. Randomization revealed only after decision recorded on clinicaltrials.gov )

First Received: July 3, 2005 Last Updated: June 5, 2008 History of Changes

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00119184

Purpose

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.

Condition	Intervention	Phase
Breech Presentation	Procedure: External cephalic version with and without spinal anesthesia	Phase I

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Prospective Randomized Study to Examine the Success Rate of External Cephalic Version for Breech Presentation at Term Presentation: Spinal Analgesia Versus No Analgesia

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Conversion of a breech to a vertex presentation [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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). [ Time Frame: 4-6 years ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 4-6 years ] [ Designated as safety issue: Yes ]
Inability to perform procedure due to maternal distress or discomfort. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]
Mode of delivery and date from the ECV. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	October 2002
Study Completion Date:	May 2008
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Intervention Details:

7.5 mg bupivacaine intrathecally

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119184

Locations

Israel
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 12000

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Carolyn F Weiniger, MB ChB

Dept Anesthesiology, Hadassah Hebrew University Medical School

More Information

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Hadassah HMO ( Dr Carolyn Weiniger )
Study ID Numbers:	20-25/01/02-HMO-CTIL
Study First Received:	July 3, 2005
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00119184 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

anesthesia
breech
external cephalic version

spinal
success
anesthesia,spinal

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor Complications
Central Nervous System Depressants

Anesthetics
Bupivacaine
Breech Presentation

Additional relevant MeSH terms:

Pregnancy Complications
Therapeutic Uses
Physiological Effects of Drugs
Obstetric Labor Complications
Central Nervous System Depressants

Anesthetics
Breech Presentation
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009