Condition category
Pregnancy and Childbirth
Date applied
29/11/2006
Date assigned
21/12/2007
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

Contact information

Type

Scientific

Primary contact

Dr Graeme Smith

ORCID ID

Contact details

Clinical Research Centre
Queen's University
Kingston General Hospital
76 Stuart Street
Angada 4
Room 5-415
Kingston
K7L 2V7
Canada
+1 613 549 6666 ext. 3936
gns@post.queensu.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FMI-63194

Study information

Scientific title

A pilot study to evaluate glyceryl trinitrate (GTN) as a novel therapeutic for the prevention and treatment of pre-eclampsia

Acronym

Study hypothesis

CIHR Grant Submission Title: Pre-eclampsia: Fetal and Maternal Outcomes and Innovative Therapies

To determine if exogenous glyceryl trinitrate (GTN), compared to placebo, will be effective at preventing the development and/or progression of clinical pre-eclampsia.

Ethics approval

Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board, Kingston, Ontario (Canada) approved on the 20th September 2002 (ref: ANAT-017-02)

Study design

Randomised, multicentre, blinded, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-eclampsia

Intervention

The study is a randomised blinded drug/placebo trial. The randomisation scheme was prepared by an independent statistician prior to initiation of the pilot study, and prepared in blocks for if and when Ottawa Hospital comes on board. The study investigators, associated staff, outcome assessor, data analyst and the study participants will all be blinded to the treatment allocation. ISMN and placebo capsules will be prepared to have identical shape, size, color, smell and feel. No form of identification labeling will be visible on either intervention. When a suitable participant is identified, the research nurse coordinator will explain the details and potential risks and benefits of the study. If consent is granted, the research nurse coordinator will determine the treatment assignment for that subject by calling the research pharmacist who will provide the next code indicating the treatment for a given patient. Patients will then be provided with an appropriately labeled package of pills prepared by the hospital pharmacy.

Prevention Arm:
Experimental intervention: Daily dose of low dose Isosorbide-5-mononitrate (ISMN) (30 mg) beginning after 20 weeks gestation till delivery.
Control intervention: Matching placebo containing lactose. Patients randomly assigned to either receive low dose ISMN (30 mg) as stated above or placebo.

Management Arm:
Experimental intervention: Daily dose of low dose Isosorbide-5-mononitrate (ISMN) (30 mg) following diagnosis of pre-eclampsia after 24 weeks gestation till delivery.
Control intervention: Matching placebo containing lactose. Patients randomly assigned to either receive low dose ISMN (30 mg) as stated above or placebo.

In both arms of the study, patients will receive standard clinical care. Total duration of treatment in each arm is flexible and based on each individual participant. There is no follow-up after delivery.

Intervention type

Drug

Phase

Not Applicable

Drug names

Glyceryl trinitrate

Primary outcome measures

Prevention arm: incidence of pre-eclampsia in the ISMN/placebo groups, measured at delivery
Treatment arm: randomisation-to-delivery interval between ISMN/placebo groups, measured at delivery

Secondary outcome measures

1. Serial change in biochemical markers in treatment/no treatment groups in each of the studies, measured at routine obstetrical visits until delivery (generally every 2 weeks)
2. Incidence of any side effects (major or minor), measured at routine obstetrical visits until delivery (generally every 2 weeks)
3. Neonatal outcomes (composite of neonatal morbidity), measured at delivery

Overall trial start date

01/01/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Women of childbearing years (approximately 18 - 42 years).

Prevention arm:
All women with a past obstetrical history of one or more cases of severe early onset pre-eclampsia or later onset severe pre-eclampsia associated with haemolysis, elevated liver enzymes, low blood levels of platelets (HELLP) syndrome.

Treatment arm:
All women that have been diagnosed with pre-eclampsia that are being followed clinically and that provide informed consent. For a diagnosis of pre-eclampsia a patient must meet all three criteria:
1. Systolic blood pressure greater than 140 mmHg or an increase of 30 mmHg from the participant’s baseline (with that increase present at two measurements taken 6 hours apart)
2. Diastolic blood pressure greater than 90 mmHg or an increase of 15 mmHg from the participant’s baseline (with that increase present at two measurements taken 6 hours apart)
3. Proteinuria greater than 0.3 g in 24 hour urine or 2+ on dipstick

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80 women in total: prevention arm (40), treatment arm (40)

Participant exclusion criteria

Potential women excluded are those:
1. That have a contraindication to use of isosorbide mononitrate (ISMN)
2. That have either a maternal or foetal indication for delivery
3. That have a diagnosis of severe pre-eclampsia (diastolic blood pressure greater than 100 mmHg; proteinuria greater than 1 g/d), eclampsia, or HELLP syndrome at time of recruitment

Recruitment start date

01/01/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Clinical Research Centre
Kingston
K7L 2V7
Canada

Sponsor information

Organisation

Queen's University (Canada)

Sponsor details

99 University Avenue
Kingston
K7L 3N6
Canada
gns@post.queensu.ca

Sponsor type

University/education

Website

http://www.queensu.ca/homepage/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: FMI-63194)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes