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Intravenous (IV) Nitroglycerin for Versions in Multiparous Women (INVERT (02))

Primary Purpose

Breech Presentation, Pregnancy Complication

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
IV Nitroglycerin
Normal saline
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 consent form

Sites / Locations

  • Foothills Medical Centre
  • Peter Lougheed Centre
  • Rockyview Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2

1

Arm Description

Placebo solution was normal 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.

Treatment solution consisted of 100micrograms/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.

Outcomes

Primary Outcome Measures

Success of ECV (if fetus turned from Breech to cephalic) at end of ECV procedure

Secondary Outcome Measures

Success of ECV (ie fetus in cephalic presentation) recorded at time of delivery
Mode of delivery
Maternal side effects and adverse events

Full Information

First Posted
May 13, 2009
Last Updated
August 27, 2013
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT00901758
Brief Title
Intravenous (IV) Nitroglycerin for Versions in Multiparous Women
Acronym
INVERT (02)
Official Title
Intravenous (IV) Nitroglycerin for Versions in Multiparous Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 multiparous 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation, Pregnancy Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo solution was normal 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.
Arm Title
1
Arm Type
Active Comparator
Arm Description
Treatment solution consisted of 100micrograms/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.
Intervention Type
Drug
Intervention Name(s)
IV Nitroglycerin
Intervention Description
IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL
Primary Outcome Measure Information:
Title
Success of ECV (if fetus turned from Breech to cephalic) at end of ECV procedure
Time Frame
Recorded at the end of ECV attempt
Secondary Outcome Measure Information:
Title
Success of ECV (ie fetus in cephalic presentation) recorded at time of delivery
Time Frame
Recorded at time of birth
Title
Mode of delivery
Time Frame
Recorded at time of birth
Title
Maternal side effects and adverse events
Time Frame
Recorded until date of birth (up to 3 weeks' duration).

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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 consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce B Allan, MD PhD
Organizational Affiliation
Calgary Health Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4J8
Country
Canada
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Rockyview Hospital
City
Calgary
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19701035
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. Erratum In: Obstet Gynecol. 2009 Nov;114(5):1148. Wah, Raouf [corrected to Wahba, Raouf].
Results Reference
result

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Intravenous (IV) Nitroglycerin for Versions in Multiparous Women

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