Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Breech Presentation	Procedure: External cephalic version; Drug: spinal anesthesia	Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	October 2002
Actual Primary Completion Date :	March 2006
Actual Study Completion Date :	May 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: External cephalic version with spinal anesthesia; External cephalic version with spinal anesthesia	Procedure: External cephalic version; 7.5 mg bupivacaine intrathecally Drug: spinal anesthesia; spinal anesthesia
Active Comparator: External cephalic version without spinal anesthesia; External cephalic version without spinal anesthesia	Procedure: External cephalic version; 7.5 mg bupivacaine intrathecally

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Conversion of a breech to a vertex presentation [ Time Frame: 4-6 years ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. Inability to perform procedure due to maternal distress or discomfort. [ Time Frame: 4-6 years ]
4. Mode of delivery and date from the ECV. [ Time Frame: 4-6 years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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:	Dr Carolyn Weiniger, Hadassah HMO
ClinicalTrials.gov Identifier:	NCT00119184 History of Changes
Other Study ID Numbers:	20-25/01/02-HMO-CTIL
First Posted:	July 13, 2005
Last Update Posted:	November 28, 2017
Last Verified:	May 2008

Keywords provided by Hadassah Medical Organization:

anesthesia; breech; external cephalic version	spinal; success; anesthesia,spinal

Additional relevant MeSH terms:

Breech Presentation; Obstetric Labor Complications; Pregnancy Complications	Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs