NCT02007837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
4.1 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 26, 2013

Last Update Submit

November 23, 2016

Conditions

Pregnancy Induced Hypertension

Keywords

pregnancy induced hypertensiongestational hypertensionpre-eclampsiapreeclampsiahypertensive disorders in pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • 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

Study Arms (2)

Combined aspirin and multinutrient supplement

EXPERIMENTAL

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

Drug: Combined aspirin and multinutrient supplementOther: Daily text reminder text messages

Placebo

PLACEBO COMPARATOR

5mg folic acid, cellulose filler

Other: Daily text reminder text messages

Interventions

Combined aspirin and multinutrient supplementDRUG

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

Combined aspirin and multinutrient supplement
Daily text reminder text messagesOTHER
Combined aspirin and multinutrient supplementPlacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \<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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

La General Hospital

Accra, Ghana

Location

Ridge Regional Hospital

Accra, Ghana

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Diederick E Grobbee, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Patrick Frimpong, MBbCh

    Ghana Health Services

    PRINCIPAL INVESTIGATOR

  • Emmanuel K Srofenyoh, MBbCb

    Ghana Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce L Browne, MD, MSc

CONTACT

+31649650071J.L.Browne@umcutrecht.nl

Diederick E Grobbee, MD, PhD

CONTACT

+31 (0)88 755 9358D.E.Grobbee@umcutrecht.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc,PhD candidate

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 11, 2013

Study Start

January 1, 2018

Primary Completion

April 1, 2018

Study Completion

August 1, 2018

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

GH(2)