Intravenous (IV) Nitroglycerin for Versions in Multiparous Women (INVERT (02))
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?
|Breech Presentation Pregnancy Complication||Drug: IV Nitroglycerin Drug: Normal saline|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intravenous (IV) Nitroglycerin for Versions in Multiparous Women|
- 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). ]
|Study Start Date:||March 2003|
|Study Completion Date:||February 2008|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
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
IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL
Active Comparator: 1
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901758
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 4J8|
|Peter Lougheed Centre|
|Calgary, Alberta, Canada|
|Calgary, Alberta, Canada|
|Principal Investigator:||Bruce B Allan, MD PhD||Calgary Health Region|