NCT00896311

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

3.6 years

First QC Date

May 8, 2009

Last Update Submit

August 27, 2013

Conditions

Breech PresentationComplication of Pregnancy

Outcome Measures

Primary Outcomes (1)

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

    Recorded at finish of ECV attempt

Secondary Outcomes (3)

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

    Recorded at time of birth

  • Mode of delivery

    Recorded at time of birth

  • Maternal side effects and adverse events

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

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

IV NitroglycerinDRUG

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

1
Normal salineDRUG

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

2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any non-cephalic presentation
  • singleton pregnancy
  • \>/= 37 weeks gestational age
  • normal amniotic fluid volume
  • reassuring fetal heart rate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Medical Centre

Calgary, Alberta, T2N 4J8, Canada

Location

Peter Lougheed Centre

Calgary, Alberta, Canada

Location

Rockyview Hospital

Calgary, Alberta, Canada

Location

Related Publications (1)

  • Hilton J, Allan B, Swaby C, Wah 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):560-567. doi: 10.1097/AOG.0b013e3181b05a19.

    PMID: 19701035BACKGROUND

MeSH Terms

Conditions

Breech PresentationPregnancy Complications

Interventions

NitroglycerinSaline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Bruce B Allan, MD PhD

    Calgary Health Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 11, 2009

Study Start

March 1, 2003

Primary Completion

October 1, 2006

Study Completion

February 1, 2008

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

CA(3)