The Canadian preterm labour nitroglycerin trial

ISRCTN	ISRCTN20129681
DOI	https://doi.org/10.1186/ISRCTN20129681
Protocol serial number	MCT-41550
Sponsor	Queen's University (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41550), Physicians' Services Incorporated Foundation (Canada)

Submission date: 26/09/2005
Registration date: 26/09/2005
Last edited: 03/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Graeme Smith
Scientific

Clinical Research Centre
Angada 4, Room 5-415
Queens University
Kingston General Hospital
Kingston
K7L 2V7
Canada

Phone	+1 613 549 6666 ext. 3936
Email	gns@post.queensu.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Transdermal nitroglycerin to reduce the incidence of neonatal mortality in women who present in preterm labour: a placebo-controlled randomised trial
Study objectives	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(s)	Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board gave approval on the 9th March 1999
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Neonatal morbidity and prenatal mortality
Key secondary outcome measure(s)	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
Completion date	30/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	600
Key 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)
Key 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
Date of first enrolment	04/05/2001
Date of final enrolment	30/08/2006

Locations

Countries of recruitment

Canada

Study participating centre

Clinical Research Centre

Kingston
K7L 2V7
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes