Contact information
Type
Scientific
Primary contact
Dr Graeme Smith
ORCID ID
Contact details
Clinical Research Centre
Angada 4
Room 5-415
Queens University
Kingston General Hospital
Kingston
K7L 2V7
Canada
+1 613 549 6666 ext. 3936
gns@post.queensu.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-41550
Study information
Scientific title
Transdermal nitroglycerin to reduce the incidence of neonatal mortality in women who present in preterm labour: a placebo-controlled randomised trial
Acronym
Study hypothesis
To determine if transdermal nitroglycerin (GTN), compared to placebo, reduces the incidence of neonatal mortality (and/or mortality) by prolonging pregnancy in women who present in preterm labour between 24 and 32 weeks gestation.
Ethics approval
Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board gave approval on the 9th March 1999
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Preterm labour
Intervention
Patients receive a intravenous bolus of saline (500 - 1000 ml) prior to randomisation. They have 1 study patch (drug or placebo) placed and a second additional patch placed after one hour if ongoing uterine activity or further cervical changes. The patch or patches are replaced in 24 hours for a further 24 hours. Patient have maternal blood pressure monitoring every 10 minutes for one hour after a patch is placed. Antenatal corticosteroids and use of antibiotics are as per the centres protocol for patients in preterm labour.
Trial details received: 12 Sept 2005
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Neonatal morbidity and prenatal mortality
Secondary outcome measures
1. Randomisation to delivery interval
2. Incidence of preterm delivery less than 48 hours after initiation of treatment
3. Incidence of delivery within 7 days of commencement of treatment
4. Incidence of delivery prior to 34 weeks gestation
5. Frequency of chorioamnionitis in preterm delivery
6. Frequency of completed course of antenatal corticosteroids
7. Frequency of side effects
Overall trial start date
04/05/2001
Overall trial end date
30/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Greater than or equal to 24 to less than or equal to 32 weeks gestational age based on menstrual dates or earliest ultrasound scan
2. Preterm labour:
2.1. At least four painful uterine contractions per 20 minutes
2.2. Change in the cervix (change in bishop score or bishop score greater than or equal to 6)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant exclusion criteria
1. Any maternal (e.g. significant antepartum haemorrhage) or foetal (e.g. non-reassuring heart rate pattern) condition necessitating immediate delivery
2. Multiple gestations (i.e. twins, triplets etc.)
3. Premature prelabour rupture of the membranes (PPROM)
4. Intrauterine foetal demise or lethal foetal anomalies
5. Cervix dilated greater than 8 cm
6. Treatment with another agent within 24 hours
7. Previous enrolment in this trial
8. Known sensitivity to GTN
9. Failure to give consent
Recruitment start date
04/05/2001
Recruitment end date
30/08/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Clinical Research Centre
Kingston
K7L 2V7
Canada
Sponsor information
Organisation
Queen's University (Canada)
Sponsor details
828 West 10th Avenue
Kingston
K7L 3N6
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41550)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Physicians' Services Incorporated Foundation (Canada)
Alternative name(s)
PSI Foundation, PSI
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17240225
Publication citations
-
Results
Smith GN, Walker MC, Ohlsson A, O'Brien K, Windrim R, , Randomized double-blind placebo-controlled trial of transdermal nitroglycerin for preterm labor., Am. J. Obstet. Gynecol., 2007, 196, 1, 37.e1-8, doi: 10.1016/j.ajog.2006.10.868.