Breech Presentation Clinical Trial
— INVERT (01)Official title:
INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women
Verified date | August 2013 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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?
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Peter Lougheed Centre | Calgary | Alberta |
Canada | Rockyview Hospital | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
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
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 |
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