Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women

Condition(s) targeted: Breech Presentation; Complication of Pregnancy

Intervention: IV Nitroglycerin (Drug); Normal saline (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Calgary

Official(s) and/or principal investigator(s):
Bruce B Allan, MD PhD, Principal Investigator, Affiliation: Calgary Health Region

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?

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

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

Primary outcome: Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure

Secondary outcome:

Success of ECV (ie fetus in cephalic presentation) at time of delivery

Mode of delivery

Maternal side effects and adverse events

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Foothills Medical Centre, Calgary, Alberta T2N 4J8, Canada

Peter Lougheed Centre, Calgary, Alberta, Canada

Rockyview Hospital, Calgary, Alberta, Canada

University of Calgary Department of Obstetrics and Gynaecology

Related publications:

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].

Starting date: March 2003
Last updated: August 27, 2013