Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women (INVERT (01))

This study has been completed.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00896311
First received: May 8, 2009
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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?


Condition Intervention
Breech Presentation
Complication of Pregnancy
Drug: IV Nitroglycerin
Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure [ Time Frame: Recorded at finish of ECV attempt ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success of ECV (ie fetus in cephalic presentation) at time of delivery [ Time Frame: Recorded at time of birth ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: Recorded at time of birth ] [ Designated as safety issue: No ]
  • Maternal side effects and adverse events [ Time Frame: Recorded until date of birth (up to 3 weeks following ECV) ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: March 2003
Study Completion Date: February 2008
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Drug: IV Nitroglycerin
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
Placebo Comparator: 2
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
Drug: Normal saline
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896311

Locations
Canada, Alberta
Rockyview Hospital
Calgary, Alberta, Canada
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4J8
Peter Lougheed Centre
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Bruce B Allan, MD PhD Calgary Health Region
  More Information

Additional Information:
Publications:
Responsible Party: Dr Bruce Allan, Department of Obstetrics & Gynecology, Calgary Health Region
ClinicalTrials.gov Identifier: NCT00896311     History of Changes
Other Study ID Numbers: INVERT-01
Study First Received: May 8, 2009
Last Updated: August 27, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Breech Presentation
Pregnancy Complications
Obstetric Labor Complications
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014