Clinical trial NCT00896311: Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women
Official title: INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breech Presentation
Complication of Pregnancy
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 82
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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?


Eligibility 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

Primary outcomes:
measure: Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure
timeFrame: Recorded at finish of ECV attempt
Secondary outcomes:
measure: Success of ECV (ie fetus in cephalic presentation) at time of delivery
timeFrame: Recorded at time of birth
measure: Mode of delivery
timeFrame: Recorded at time of birth
measure: Maternal side effects and adverse events
timeFrame: Recorded until date of birth (up to 3 weeks following ECV)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Rockyview Hospital
state: Alberta
Study officials:
affiliation: Calgary Health Region
name: Bruce B Allan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):560-567. doi: 10.1097/AOG.0b013e3181b05a19.