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Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women

NCT00896311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2013-08-28

No results posted yet for this study

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?

Conditions

  • Breech Presentation
  • Complication of Pregnancy

Interventions

DRUG

IV Nitroglycerin

IV injection, initial dose of 1ml, with further doses of 1-3mL, 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

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Bruce B Allan, MD PhD · Calgary Health Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2006-10-31
Completion
2008-02-29

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00896311 on ClinicalTrials.gov