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Completed

NCT Number: NCT00896311

Intravenous (IV) Nitroglycerin for Versions 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?

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Key information

Conditions

Breech Presentation Complication of Pregnancy Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Nitroglycerin

Drug

IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL

normal saline

Drug

IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL

Primary outcomes

  1. Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure

    Time frame: Recorded at finish of ECV attempt

Secondary outcomes

  1. Success of ECV (ie fetus in cephalic presentation) at time of delivery

    Time frame: Recorded at time of birth

  2. Mode of delivery

    Time frame: Recorded at time of birth

  3. Maternal side effects and adverse events

    Time frame: Recorded until date of birth (up to 3 weeks following ECV)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Acronym: INVERT (01)

Important dates

Study start
2003
Primary completion
2006
Study completion
2008
First posted
May 11, 2009
Registry last updated
Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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