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ClinicalTrials.gov ID

NCT02007837

Lead Sponsor

UMC UtrechtOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

440Estimated

Last Update Posted

Nov 25, 2016Estimated

Start Date

Jan 2018

Primary Completion Date

Apr 2018Estimated

Completion Date

Aug 2018Estimated

Official Title

Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial

Brief 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.

• Pregnancy Induced Hypertension

• Combined aspirin and multinutrient supplement
• Daily text reminder text messages

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

UMC UtrechtOTHER

Collaborators

Ghana Health ServicesOTHER_GOV

University of GhanaOTHER

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