An interventional study of IV Nitroglycerin and Normal saline in Breech Presentation and Pregnancy Complication, sponsored by University of Calgary. Completed at 3 sites in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2013-08-28.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
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?
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's enrollment of 44 is below the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Placebo solution was normal saline. After an initial 1mL dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL.
Drug: Normal saline
Treatment solution consisted of 100micrograms/mL of nitroglycerin. After an initial 1mL dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL.
Drug: IV Nitroglycerin
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
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).
The record gives a start of Mar 2003, a primary completion of Oct 2006 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitroglycerin