Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women

Breech Presentation Clinical Trial

— INVERT (01)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896311
• Other study ID #: INVERT-01
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: August 27, 2013
• Start date: March 2003
• Est. completion date: February 2008

Study information

• Verified date: August 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2008
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breech Presentation
• Complication of Pregnancy
• Pregnancy Complications

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	Rockyview Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Hilton J, Allan B, Swaby C, Wahba 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. doi: 10.1097/AOG.0b013e3181b05a19. Erratum in: Obstet Gynecol. 2009 Nov;114(5):1148. Wah, Raouf [corrected to Wahba, Raouf]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure		Recorded at finish of ECV attempt	No
Secondary	Success of ECV (ie fetus in cephalic presentation) at time of delivery		Recorded at time of birth	No
Secondary	Mode of delivery		Recorded at time of birth	No
Secondary	Maternal side effects and adverse events		Recorded until date of birth (up to 3 weeks following ECV)	Yes