NCT00896311

Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women

INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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 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?

Conditions

• Breech Presentation
• Complication of Pregnancy

Interventions

Type	Name	Description
DRUG	IV Nitroglycerin	IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
DRUG	Normal saline	IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-10-01
• Completion: 2008-02-01
• First posted: 2009-05-11
• Last updated: 2013-08-28

Locations

3 sites across 1 country: Canada