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.: PACTR201503001054393 Date of Approval: 04/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between the roles of low dose aspirin and folic acid in preventing preeclampsia among high risk women screened by uterine artery Doppler at
Official scientific title Comparison between the roles of low dose aspirin and folic acid in preventing preeclampsia among high risk women screened by uterine artery Doppler at 22-24 weeks of gestation: A randomised controlled trial
Brief summary describing the background and objectives of the trial Preeclampsia is a multisystem inflammatory syndrome. It is defined as the onset of hypertension (blood pressure >140/90) and proteinuria during the second half of pregnancy (>20 weeks¿ gestation). Cnosson et al 2008 reviewed the value of uterine artery Doppler waveforms in the prediction of preeclampsia in high risk patients. They reviewed 7 studies using elevated uterine artery resistance index to predict preeclampsia. Using the integrated results of the studies; this test had a sensitivity of 57% and specificity of 86% in preeclampsia prediction. Prophylaxis with low-dose aspirin has been recommended to prevent preeclampsia. The rationale is that hypertension and abnormalities of coagulation in this disease are caused in part by imbalance between vasodilating and vasoconstricting prostaglandins. There are several lines of biologic evidence that tend to support the role of folic acid in the prevention of preeclampsia. First, hyperhomocysteinemia has been associated with preeclampsia. Second, persons with genetic disturbances in the folate-mediated methylation pathway of homocysteine have increased plasma homocysteine levels, Third, folic acid supplementation improves endothelial function in adults with hyperhomocysteinemia. The objectives of this study is to evaluate and compare the roles of low dose aspirin and folic acid in the prevention of preeclampsia in high risk patients with high resistance in the uterine artery documented by uterine artery Doppler waveforms at 22-24 weeks of gestation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Preeclampsia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 07/05/2013
Actual trial start date 07/05/2013
Anticipated date of last follow up 30/04/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 210
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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 random numbers Sealed opaque envelops Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aspirin 75mg/day Throughout pregnancy women will be advised to receive Aspirin 75 mg daily throughout pregnancy 70
Experimental Group Folic acid 1gm/day Throughout pregnancy women will be advised to receive Folic acid 1gm daily throughout pregnancy 70
Control Group No treatment 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Uterine artery Doppler resistance index exceeds 0.68 with or without an early diastolic notch at 22-24 weeks of geatation. -High risk patients for developing preeclampsia defined by having any of the following risk factors: chronic hypertension, pregestational diabetes mellitus, body mass index (BMI) > 30kg/m² or past history of preeclampsia Multifetal pregnancy. Antiphospholipid syndrome. Ruptured membranes. Major congenital anomalies. Patients already receiving prophylactic therapy. Patients with known allergy to aspirin or folic acid 20 Year(s) 40 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
Yes 20/03/2013 Department of Gynecology and Obstetrics
Ethics Committee Address
Street address City Postal code Country
1 Alsaraya street AlManial 11559 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Preeclampsia development followed up every 2 weeks until 30 weeks, Weekly thereafter, each visit blood pressure measured; urine dipstick to check for proteinuria, presence confirmed by urinary protein :creatinine ratio. Preeclampsia diagnosed blood pressure 140/90 mmHg on two separate occasions more than 4 hours apart accompanied with urinary protein : creatinine ratio is greater than 30 mg/mmol.
Secondary Outcome Early onset eclampsia Early onset preeclampsia will be diagnosed if preeclampsia before 34 weeks
Secondary Outcome Severe preeclampsia Severe preeclampsia diagnosed if diastolic blood pressure 10 mmHg or greater, systolic blood pressure 160 mmHg or greater, occurrence of preeclampsia symptoms, biochemical or haematological impairment .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University hospitals 1 Alsaraya street, AlManial Cairo 11559 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University 1 Alsaraya street, AlManial Cairo 11559 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Cairo University 1 Alsaraya street, AlManial Cairo 11559 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AbdelGany Hassan abdelgany2@gmail.com +201017801604 60 Fostat appartment, Misr AlKadeema
City Postal code Country Position/Affiliation
Cairo 11411 Egypt Lecturer of Gynecology and Obstetrics, Cairo university, Egypt
Role Name Email Phone Street address
Public Enquiries AbdelGany Hassan abdelgany2@gmail.com +201017801604 60 Fostat appartment, Misr AlKadeema
City Postal code Country Position/Affiliation
Cairo 11411 Egypt Lecturer of Gynecology and Obstetrics, Cairo university, Egypt
Role Name Email Phone Street address
Scientific Enquiries AbdelGany Hassan abdelgany2@gmail.com +201017801604 60 Fostat appartment, Misr AlKadeema
City Postal code Country Position/Affiliation
Cairo 11411 Egypt Lecturer of Gynecology and Obstetrics, Cairo university, Egypt
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