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

NCT ID: NCT02007837

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Induced Hypertension

Keywords

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pregnancy induced hypertension gestational hypertension pre-eclampsia preeclampsia hypertensive disorders in pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Combined aspirin and multinutrient supplement

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

Group Type EXPERIMENTAL

Combined aspirin and multinutrient supplement

Intervention Type DRUG

Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed.

Daily text reminder text messages

Intervention Type OTHER

Placebo

5mg folic acid, cellulose filler

Group Type PLACEBO_COMPARATOR

Daily text reminder text messages

Intervention Type OTHER

Interventions

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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.

Intervention Type DRUG

Daily text reminder text messages

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ghana Health Services

OTHER_GOV

Sponsor Role collaborator

University of Ghana

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Joyce L. Browne

MD, MSc,PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diederick E Grobbee, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Patrick Frimpong, MBbCh

Role: PRINCIPAL_INVESTIGATOR

Ghana Health Services

Emmanuel K Srofenyoh, MBbCb

Role: PRINCIPAL_INVESTIGATOR

Ghana Health Services

Locations

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La General Hospital

Accra, , Ghana

Site Status

Ridge Regional Hospital

Accra, , Ghana

Site Status

Countries

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Ghana

Central Contacts

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Joyce L Browne, MD, MSc

Role: CONTACT

Phone: +31649650071

Email: [email protected]

Diederick E Grobbee, MD, PhD

Role: CONTACT

Phone: +31 (0)88 755 9358

Email: [email protected]

Facility Contacts

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Patrick Frimpong, MBChB

Role: primary

Emmanuel K Srofenyoh, MBChB

Role: primary

Other Identifiers

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GHS-ERC: 05/05/2012

Identifier Type: -

Identifier Source: org_study_id