Breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. As an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ECV). Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials. This study is designed to answer the following questions for multiparous women: Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates? Will an increase in ECV success result in a decreased cesarean section rate?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL.
IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL
Foothills Medical Centre
Calgary, Alberta, Canada
Peter Lougheed Centre
Calgary, Alberta, Canada
Rockyview Hospital
Calgary, Alberta, Canada
Success of ECV (if fetus turned from Breech to cephalic) at end of ECV procedure
Time frame: Recorded at the end of ECV attempt
Success of ECV (ie fetus in cephalic presentation) recorded at time of delivery
Time frame: Recorded at time of birth
Mode of delivery
Time frame: Recorded at time of birth
Maternal side effects and adverse events
Time frame: Recorded until date of birth (up to 3 weeks' duration).
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