Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women (INVERT (01))

This study has been completed.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00896311
First received: May 8, 2009
Last updated: August 27, 2013
Last verified: August 2013

May 8, 2009
August 27, 2013
March 2003
October 2006   (final data collection date for primary outcome measure)
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure [ Time Frame: Recorded at finish of ECV attempt ] [ Designated as safety issue: No ]
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure [ Time Frame: At end of ECV procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00896311 on ClinicalTrials.gov Archive Site
  • Success of ECV (ie fetus in cephalic presentation) at time of delivery [ Time Frame: Recorded at time of birth ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: Recorded at time of birth ] [ Designated as safety issue: No ]
  • Maternal side effects and adverse events [ Time Frame: Recorded until date of birth (up to 3 weeks following ECV) ] [ Designated as safety issue: Yes ]
  • Success of ECV (ie fetus in cephalic presentation) at time of delivery [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
  • Maternal side effects and adverse events [ Time Frame: During ECV ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women
INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women

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?

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Breech Presentation
  • Complication of Pregnancy
  • 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
  • Active Comparator: 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
    Intervention: Drug: IV Nitroglycerin
  • Placebo Comparator: 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
    Intervention: Drug: Normal saline
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):560-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
February 2008
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • any non-cephalic presentation
  • singleton pregnancy
  • >/= 37 weeks gestational age
  • normal amniotic fluid volume
  • reassuring fetal heart rate

Exclusion Criteria:

  • labor
  • 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
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00896311
INVERT-01
No
Dr Bruce Allan, Department of Obstetrics & Gynecology, Calgary Health Region
University of Calgary
Not Provided
Principal Investigator: Bruce B Allan, MD PhD Calgary Health Region
University of Calgary
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP