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Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major causes of maternal mortality worldwide, especially in low and middle income countries. This trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced hypertension in women at risk. Secondary and tertiary objectives include other maternal and neonatal outcomes.
Details
| Lead sponsor | UMC Utrecht |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 440 |
| Start date | 2018-01 |
| Completion | 2018-08 |
Conditions
- Pregnancy Induced Hypertension
Interventions
- Combined aspirin and multinutrient supplement
- Daily text reminder text messages
Primary outcomes
- Development of pregnancy-induced hypertension (PIH) in pregnancy — up to 2 days after delivery.
Development of a de novo systolic blood pressure (SBP) of \> 140 mmHg, diastolic blood pressure (DBP) of \>90 mmHg, measured at least twice.
Countries
Ghana