se of a nitric oxide (ISMN) for the PREVENTION and MANAGEMENT of pre-eclampsia (pilot study)
- Conditions
- Pre-eclampsiaPregnancy and Childbirth
- Registration Number
- ISRCTN45790835
- Lead Sponsor
- Queen's University (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevention arm: incidence of pre-eclampsia in the ISMN/placebo groups, measured at delivery<br>Treatment arm: randomisation-to-delivery interval between ISMN/placebo groups, measured at delivery
- Secondary Outcome Measures
Name Time Method 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)<br>2. Incidence of any side effects (major or minor), measured at routine obstetrical visits until delivery (generally every 2 weeks)<br>3. Neonatal outcomes (composite of neonatal morbidity), measured at delivery