NCT02007837|UnknownPhase 3DMC
Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial
4P
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4P
Sponsor study identifier
interventional
440
1 country
2
Study Start
January 2018
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 26, 2013
Actual (reported)December 11, 2013
Actual (reported)January 2018
Date type not reportedThis date has not been verified as actual or estimated.
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Development of pregnancy-induced hypertension (PIH) in pregnancy
Development of a de novo systolic blood pressure (SBP) of \> 140 mmHg, diastolic blood pressure (DBP) of \>90 mmHg, measured at least twice.
up to 2 days after delivery.
Maternal/obstetric outcomes
6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Neonatal and infant outcomes
6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
Number of participants with (severe) adverse events as a measure of safety and tolerability
1 year
In a single capsule, the following will be combined: 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12
5mg folic acid, cellulose filler
Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Combined aspirin and multinutrient supplement
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordLa General Hospital
Accra, Ghana
Ridge Regional Hospital
Accra, Ghana
Diederick E Grobbee, MD PhD
UMC Utrecht
Patrick Frimpong, MBbCh
Ghana Health Services
Emmanuel K Srofenyoh, MBbCb
Ghana Health Services
First Submitted
November 26, 2013
First Posted
December 11, 2013
Study Start
January 2018
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Hypertension In Postpartum Preeclampsia Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
April 2018
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 25, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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