Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women
NCT ID: NCT00896311
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2003-03-31
2008-02-29
Brief Summary
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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 nulliparous 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?
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Treatment solution consisted of 100 micrograms/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
IV Nitroglycerin
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
2
Placebo solution was 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
Normal saline
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
Interventions
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IV Nitroglycerin
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
Normal saline
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
Eligibility Criteria
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Inclusion Criteria
* singleton pregnancy
* \>/= 37 weeks gestational age
* normal amniotic fluid volume
* reassuring fetal heart rate
Exclusion Criteria
* ruptured membranes
* history of third trimester bleeding
* any pre-existing uterine scar
* pregnancy induced hypertension and gestational diabetes
* oligohydramnios and polyhydramnios
* intrauterine growth restriction or macrosomia
* hypotension or any serious medical illness
* inability to comprehend the consent form
FEMALE
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Department of Obstetrics & Gynecology, Calgary Health Region
Principal Investigators
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Bruce B Allan, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Calgary Health Region
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Peter Lougheed Centre
Calgary, Alberta, Canada
Rockyview Hospital
Calgary, Alberta, Canada
Countries
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References
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Hilton J, Allan B, Swaby C, Wah R, Jarrell J, Wood S, Ross S, Tran Q. Intravenous nitroglycerin for external cephalic version: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):560-567. doi: 10.1097/AOG.0b013e3181b05a19.
Other Identifiers
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INVERT-01
Identifier Type: -
Identifier Source: org_study_id