The Canadian preterm labour nitroglycerin trial
| ISRCTN | ISRCTN20129681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20129681 |
| Secondary identifying numbers | MCT-41550 |
- 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
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 |
|---|---|
| gns@post.queensu.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 04/05/2001 |
| Completion date | 30/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
K7L 2V7
Canada
Sponsor information
Queen's University (Canada)
University/education
University/education
828 West 10th Avenue
Kingston
K7L 3N6
Canada
| Website | http://www.queensu.ca/ |
|---|---|
"ROR" |
https://ror.org/02y72wh86 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41550)
No information available
Physicians' Services Incorporated Foundation (Canada)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- PSI Foundation, PSI
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
