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

August 27, 2013 updated by: University of Calgary

INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Peter Lougheed Centre
      • Calgary, Alberta, Canada, T2N 4J8
        • Foothills Medical Centre
      • Calgary, Alberta, Canada
        • Rockyview Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure
Time Frame: Recorded at finish of ECV attempt
Recorded at finish of ECV attempt

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 8, 2009

First Posted (ESTIMATE)

May 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INVERT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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