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

Breech Presentation Clinical Trial

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

Clinical Trial 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?

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00896311
Study type Interventional
Source University of Calgary
Contact
Status Completed
Phase N/A
Start date March 2003
Completion date February 2008
View Details
See also
  Status Clinical Trial Phase
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Completed NCT01487590 - Cephalic Version by Acupuncture-Moxibustion for Breech Presentation N/A
Completed NCT00890474 - Moxibustion for Fetus in Breech Presentation Phase 3
Terminated NCT00119184 - Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version Phase 1
Completed NCT05827627 - Simulation Techniques Used in Breech Birth Management Training N/A
Terminated NCT04538261 - Elevation of the Fetal Buttocks Prior to External Cephalic Version N/A
Recruiting NCT02801201 - Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation Phase 3
Completed NCT02331160 - Rebozo and External Cephalic Version in Breech Presentation. N/A
Completed NCT00901758 - Intravenous (IV) Nitroglycerin for Versions in Multiparous Women N/A
Not yet recruiting NCT02167841 - Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation. N/A
Completed NCT01048398 - Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions. Phase 3
Recruiting NCT04613778 - Correction of Breech Presentation With Laser Acupuncture N/A
Completed NCT01708018 - Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy N/A
Terminated NCT00465712 - Effect of Amnioinfusion on External Cephalic Version Successful Rate N/A
Recruiting NCT03827226 - Breech External Cephalic Version Intervention Trial
Completed NCT00813683 - Cephalic Version by Acupuncture for Breech Presentation N/A
Recruiting NCT06187948 - An Informative Video Before Planned External Cephalic Version N/A
Completed NCT00141687 - Early External Cephalic Version (ECV) 2 Trial N/A