Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women

Not Applicable

Completed

• Conditions: Breech Presentation; Complication of Pregnancy
• Interventions: Drug: IV Nitroglycerin; Drug: Normal saline

• Registration Number: NCT00896311
• Lead Sponsor: University of Calgary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2006-10
• Study Completion: 2008-02
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-11
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	IV Nitroglycerin	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
2	Normal saline	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

Primary Outcome Measures

Name	Time	Method
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure	Recorded at finish of ECV attempt

Secondary Outcome Measures

Name	Time	Method
Success of ECV (ie fetus in cephalic presentation) at time of delivery	Recorded at time of birth
Mode of delivery	Recorded at time of birth
Maternal side effects and adverse events	Recorded until date of birth (up to 3 weeks following ECV)

Trial Locations

Locations (3)

Peter Lougheed Centre; 🇨🇦 Calgary, Alberta, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Rockyview Hospital; 🇨🇦 Calgary, Alberta, Canada