Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201311000700893 Date of Approval: 08/11/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial
Official scientific title Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) ¿ a randomised, placebo-controlled, double-blind clinical trial.
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 4P trial
Disease(s) or condition(s) being studied Circulatory System,Hypertensive disorders in pregnancy, pregnancy-induced hypertension, preeclampsia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2015
Actual trial start date
Anticipated date of last follow up 28/10/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 440
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ERC 05/05/2012
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated stratified parallel blocks per study site Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Polypill 80mg low-dose aspirin, 1.8 grams calcium, 600IE vitamin D, 5mg folic acid and 1000 ¿g vitamin B12 Enrolment (6-18 weeks gestation) until 34 weeks of gestation Polypill 220 Placebo
Control Group Placebo 5mg folic acid, cellulose filler Enrolment (6-18 weeks gestation) until 34 weeks of gestation Placebo 220 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- <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 - 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 18 Year(s) 99 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 05/05/2012 Ethical Review Committee Ghana Health Services
Ethics Committee Address
Street address City Postal code Country
Accra Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pregnancy-induced hypertension 6-16 weeks gestation 16-24 weeks gestation 26-36 weeks gestation Until delivery and first days after
Secondary Outcome Maternal/obstetric outcomes: maternal death, preeclampsia, eclampsia, HELLP syndrome, hemorrhage, saesarian section, other complications during pregnancy or delivery 6-16 weeks gestation 16-24 weeks gestation 26-36 weeks gestation Until delivery and first days after
Secondary Outcome Neonatal and infant outcomes: preterm birth, Intra uterine death, stillbirth, neonatal mortality, congenitial abnormality, NICU admission or pediatrician referral, birth weight, small for gestational age, apgar scores, other adverse effects. Infant outcomes: weight and hight, health, occurrence of disease and general health status. 6-16 weeks gestation 16-24 weeks gestation 26-36 weeks gestation Until delivery and first days after
Secondary Outcome Tertiary: uptake and tolerability To determine whether the intervention is safe and well tolerated in pregnant women at an increased risk of hypertensive disorders in pregnancy.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
La General Hospital Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
University Medical Center Utrecht Universiteitsweg 100 Utrecht 3584 CG Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Medical Center Utrecht Universiteitsweg 100 Utrecht 3584 CG Netherlands University
COLLABORATORS
Name Street address City Postal code Country
Dr. Emmanuel Srofenyoh Accra Ghana
Dr. Patrick Frimpong Accra Ghana
Prof. Dr. Diederick Grobbee Universiteitsweg 100 Utrecht 3584CG Netherlands
Dr. Joyce Browne Universiteitsweg 100 Utrecht 3584 CG Netherlands
Prof. Dr. Kerstin Klipstein-Grobusch Universiteitsweg 100 Utrecht 3584 CG Netherlands
Dr. Edward Antwi Accra Ghana
Prof. Dr. Irene Agyepong Accra Ghana
Prof. Dr. Cuno Uiterwaal Universiteitsweg 100 Utrecht 3584 CG Netherlands
Prof. Dr. Arie Franx Universiteitsweg 100 Utrecht 3584 CG Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Diederick (Rick) Grobbee D.E.Grobbee@umcutrecht.nl +31 (0)88 755 9358 Universiteitsweg 100
City Postal code Country Position/Affiliation
Utrecht 3584 CG Netherlands Prof. of Clinical Epidemiology
Role Name Email Phone Street address
Public Enquiries Joyce Browne J.L.Browne@umcutrecht.nl +31649650071 Universiteitsweg 100
City Postal code Country Position/Affiliation
Utrecht 3584 CG Netherlands Coordinating Investigator
Role Name Email Phone Street address
Scientific Enquiries Joyce Browne joyce.browne@gmail.com +31649650071 Universiteitsweg 100
City Postal code Country Position/Affiliation
Utrecht 3584 CG Netherlands Coordinating Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information