Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: Ghana Health Services; University of Ghana
• Treatments: Aspirin; Folic Acid

Criteria

Inclusion Criteria:

• <16 weeks of gestation and over 18 years of age,

• Intention to have subsequent antenatal visits and delivery at the same clinic.

• Can receive text messages by phone or through the phone of a proxy.

• A moderate to high risk (>20%) of developing PIH

Exclusion Criteria:

• Pre-existing hypertension or hypertension before 20 weeks gestation.

• Likely non-compliance with the protocol in view of the treating physician

• Comorbidity interfering with the protocol

• Known contraindications to Investigational Product components