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

NCT02007837 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2016-11-25

No results posted yet for this study

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

  • Pregnancy Induced Hypertension

Interventions

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

Sponsors & Collaborators

  • Ghana Health Services

    collaborator OTHER_GOV

  • University of Ghana

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Diederick E Grobbee, MD PhD · UMC Utrecht

  • Patrick Frimpong, MBbCh · Ghana Health Services

  • Emmanuel K Srofenyoh, MBbCb · Ghana Health Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2018-04-30
Completion
2018-08-31

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02007837 on ClinicalTrials.gov