Breech PresentationINVERT (01)NCT00896311
Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women
A study testing IV Nitroglycerin and Normal saline in people with Breech Presentation and Complication of Pregnancy, run by University of Calgary at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breech Presentation, Complication of Pregnancy
- What is being tested?
- IV Nitroglycerin and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2003to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any non-cephalic presentation
- singleton pregnancy
- >/= 37 weeks gestational age
- normal amniotic fluid volume
- reassuring fetal heart rate
Who cannot join
- labor
- ruptured membranes
- history of third trimester bleeding
- any pre-existing uterine scar
- pregnancy induced hypertension and gestational diabetes
- oligohydramnios and polyhydramnios
Show all 9Show fewer
- intrauterine growth restriction or macrosomia
- hypotension or any serious medical illness
- inability to comprehend the consent form
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Foothills Medical Centre
Calgary, Alberta, T2N 4J8
Peter Lougheed Centre
Calgary, Alberta
Rockyview Hospital
Calgary, Alberta
About this study
Official title: INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial 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.
Read more
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
- Being tested
- IV Nitroglycerin, Normal saline
- Medical subject headings
- Breech Presentation, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV NitroglycerinDrug
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
Normal salineDrug
IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure
Measured: Recorded at finish of ECV attempt
Secondary outcomes (3)
Success of ECV (ie fetus in cephalic presentation) at time of delivery
Measured: Recorded at time of birth
Mode of delivery
Measured: Recorded at time of birth
Maternal side effects and adverse events
Measured: Recorded until date of birth (up to 3 weeks following ECV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startMar 2003
- Primary completionOct 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Bruce B Allan, MD PhD, Principal investigator, Calgary Health Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896311
- Sponsor's protocol ID
- INVERT-01
- Acronym
- INVERT (01)
- Status last verified
- Aug 2013
- First submitted
- 8 May 2009
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19701035
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women
- ClinicalTrials.gov ID
- NCT00896311
- Acronym / sponsor ID
- INVERT (01) / INVERT-01
- Conditions
- Breech Presentation, Complication of Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: IV NitroglycerinTreatment 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 |
| 2 | Placebo comparator | Drug: Normal salinePlacebo 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- any non-cephalic presentation
- singleton pregnancy
- >/= 37 weeks gestational age
- normal amniotic fluid volume
- reassuring fetal heart rate
Key exclusion criteria (9 listed)
- labor
- ruptured membranes
- history of third trimester bleeding
- any pre-existing uterine scar
- pregnancy induced hypertension and gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV NitroglycerinIV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL | Drug | 1 |
| Normal salineIV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL | Drug | 2 |
Primary outcome
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure
Time frame: Recorded at finish of ECV attempt
3 secondary outcomes
Success of ECV (ie fetus in cephalic presentation) at time of delivery
Time frame: Recorded at time of birth
Mode of delivery
Time frame: Recorded at time of birth
Maternal side effects and adverse events
Time frame: Recorded until date of birth (up to 3 weeks following ECV)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Background: PubMed 19701035Hilton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce B Allan, MD PhD principal investigator
Calgary Health Region
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV Nitroglycerin and Normal saline in people with Breech Presentation and Complication of Pregnancy, run by University of Calgary at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure (time frame: Recorded at finish of ECV attempt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00896311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.