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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00896311
Other study ID # INVERT-01
Secondary ID
Status Completed
Phase N/A
First received May 8, 2009
Last updated August 27, 2013
Start date March 2003
Est. completion date February 2008

Study information

Verified date August 2013
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

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?


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date February 2008
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

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


Intervention

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

Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta
Canada Peter Lougheed Centre Calgary Alberta
Canada Rockyview Hospital Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Hilton J, Allan B, Swaby C, Wahba R, Jarrell J, Wood S, Ross S, Tran Q. Intravenous nitroglycerin for external cephalic version: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):560-7. doi: 10.1097/AOG.0b013e3181b05a19. Erratum in: Obstet Gynecol. 2009 Nov;114(5):1148. Wah, Raouf [corrected to Wahba, Raouf]. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure Recorded at finish of ECV attempt No
Secondary Success of ECV (ie fetus in cephalic presentation) at time of delivery Recorded at time of birth No
Secondary Mode of delivery Recorded at time of birth No
Secondary Maternal side effects and adverse events Recorded until date of birth (up to 3 weeks following ECV) Yes
See also
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Not yet recruiting NCT01922453 - Music and Sounds for ECV N/A
Completed NCT00516555 - EBIS: The Eindhoven Breech Intervention Study N/A
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