Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
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 whe
Sponsors
Queen's University (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed