Clinical Trial: Intravenous (IV) Nitroglycerin for Versions in Multiparous Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intravenous (IV) Nitroglycerin for Versions in Multiparous Women

Brief 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 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?


Detailed Summary:
Sponsor: University of Calgary

Current Primary Outcome: Success of ECV (if fetus turned from Breech to cephalic) at end of ECV procedure [ Time Frame: Recorded at the end of ECV attempt ]

Original Primary Outcome: Success of ECV (ie fetus in cephalic presentation) at the end of ECV procedure [ Time Frame: At end of ECV procedure ]

Current Secondary Outcome:

  • 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). ]


Original Secondary Outcome:

  • Success of ECV (ie fetus in cephalic presentation) at time of delivery [ Time Frame: Time of delivery ]
  • Mode of delivery [ Time Frame: At time of delivery ]
  • Maternal side effects and adverse events [ Time Frame: During ECV ]


Information By: University of Calgary

Dates:
Date Received: May 13, 2009
Date Started: March 2003
Date Completion:
Last Updated: August 27, 2013
Last Verified: August 2013