Breech Presentation Clinical Trial
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
Verified date | May 2008 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 140 |
Est. completion date | May 2008 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Hebrew University Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conversion of a breech to a vertex presentation | 4-6 years | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Inability to perform procedure due to maternal distress or discomfort. | 4-6 years | ||
Secondary | Mode of delivery and date from the ECV. | 4-6 years |
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