Trials / Unknown
UnknownNCT02007837
Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial
Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- Sponsor
- UMC Utrecht · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Combined aspirin and multinutrient supplement | Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed. |
| OTHER | Daily text reminder text messages |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2018-04-01
- Completion
- 2018-08-01
- First posted
- 2013-12-11
- Last updated
- 2016-11-25
Locations
2 sites across 1 country: Ghana
Source: ClinicalTrials.gov record NCT02007837. Inclusion in this directory is not an endorsement.