Condition category
Pregnancy and Childbirth
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.perinet.org

Contact information

Type

Scientific

Primary contact

Dr Graeme Smith

ORCID ID

Contact details

Clinical Research Centre
Angada 4
Room 5-415
Queen’s 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

http://www.queensu.ca/

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

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

  1. 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.

Additional files

Editorial Notes