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)
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00119184
First received: July 3, 2005
Last updated: June 5, 2008
Last verified: May 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

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:
    Procedure: External cephalic version with and without spinal anesthesia
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014