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.: PACTR201105000267371 Date of Registration: 06/12/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title WHO randomized trial of calcium supplementation before pregnancy to reduce recurrent pre-eclampsia
Official scientific title WHO randomized trial of calcium supplementation before pregnancy to reduce recurrent pre-eclampsia
Brief summary describing the background and objectives of the trial This is a randomized placebo-controlled trial aiming to determine the effect of calcium supplementation before and in the first half of pregnancy on incidence of pre-eclampsia, hypertension and other pregnancy outcomes. Hypothesis: calcium supplementation before pregnancy reduces the incidence of recurrent pre-eclampsia more effectively than supplementation starting at 20 weeks' gestation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CAP study
Disease(s) or condition(s) being studied calcium supplementation for pre-eclampsia,Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 17/01/2011
Actual trial start date 01/07/2011
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 540
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
M10977 Univ. of the Witwatersrand Ethics committee clearance certificate
A65750 WHO trial identification number
South African National Clinical Trial Registry SANCTR
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 using computer-generated random numbers in balanced blocks of variable size, stratified by site Allocation was determined by the holder of the sequence who is situated off site 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 Calcium Supplementation 500 mg daily from enrollment before pregnancy until 20 weeks gestation Calcium supplementation 270
Control Group Control placebo 500 mg daily enrolment (before pregnancy) until 20 weeks gestation placebo 270 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Previous pre-eclampsia or eclampsia in most recent pregnancy 2. Planning to get pregnant 1. No history of pre-eclampsia or eclampsia 2. Age <18 years 3. Chronic hypertension 4. Already pregnant 5. Taking calcium supplementation 6. History or symptoms of urolithiasis, renal disease or parathyroid disease 7. Not in a sexual relationship 8. Using long-term contraception (eg hormonal, IUD, sterilization) 9. Unwilling to give informed consent 18 Year(s) 45 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 03/12/2010 WITS ethics committee
Ethics Committee Address
Street address City Postal code Country
Johannesburg South Africa
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 03/12/2010 University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital Old Main Building Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pre-eclampsia During pregnancy or postpartum period
Primary Outcome Pre-eclampsia or pregnancy loss before labor at any gestation Pregnancy before labour
Secondary Outcome No conception during study period throughout trial
Secondary Outcome Pregnancy loss before labour Pregnancy
Primary Outcome Severe maternal morbidity and mortality index: defined as one or more of the secondary outcomes pregnancy or postpartum period
Secondary Outcome Gestational hypertension Pregnancy or postpartum period Defined as diastolic bp greater or equal to 90mmHG on two occasions 4hours apart or greater or equal to 110mmHg once, and or systolic bp greater or equal to 140mmHg on two occasions 4 hours apart or 160mmHg once after 20 weeks gestation
Secondary Outcome Gestational proteinuria Pregnancy or postpartum period. Defined as 2 positive or more on urine dipstix, or greater than 300mg per 24 hours or greater than 500mg per Litre or unrinary protein creatinine ratio greater than .034g per mmol after 20 weeks gestation
Secondary Outcome HELLP Syndrome During Pregnancy or postpartum period. Defined as hemolysis LDH greater than 600 U per L or bilirubin greater than or equal to 1.2mg per dl, elevated liver enzymes where AST greater than or equal to 70 u per L and low platelet count less than 100x10 to the ninth per L
Secondary Outcome ICU admission greater than 24 hours pregnancy or postpartum period
Secondary Outcome Severe gestational hypertension During pregnancy or postpartum period. systolic bp greater or equal to 160mmHG on two occasions 4hrs apart or once followed by anthypertensive therpay, and or diastolic bp greater or equal to 110mmHg on two occasions 4 hrs apart or once followed by anthypertensive therapy after 20 weeks
Secondary Outcome Early onset pre-eclampsia (at less than 32 weeks) pregnancy
Secondary Outcome Severe pre-eclampsia proteinuria plus severe diastolic and or systolic hypertension during pregnancy or postpartum period
Secondary Outcome Moderately severe thrombocytopenia greater than 100 x 10 to the ninth per L during pregnancy and postpartum periods
Secondary Outcome Uric acid greater or equal to values for gestational age pregnancy and postpartum period
Secondary Outcome Renal Failure defined as creatinine greater than or equal to 120mmol per liter pregnancy or postpartum period
Secondary Outcome Pulmonary oedema pregnancy or postpartum period
Secondary Outcome Cerebrovascular accident pregnancy or postpartum period
Secondary Outcome Liver failure defined as AST greater than or equal to 70 U per L pregnancy or postpartum period
Secondary Outcome Ecplampsia pregnancy or postpartum period
Secondary Outcome Placental abruption pregnancy
Secondary Outcome maternal death pregnancy or postpartum period
Secondary Outcome Mothers hospital stay lasts 7 days or more after birth postpartum period
Secondary Outcome Caesarean Section pregnancy
Secondary Outcome Birthweight less than 2500g day of birth
Secondary Outcome Preterm birth less than 37 weeks gestation day of birth
Secondary Outcome Early preterm birth less than 32 weeks gestation day of birth
Secondary Outcome Apgar score less than 7 at five minutes 5 minutes after birth
Secondary Outcome Death or admission ot neonatal unit ICU for 24 hours or more neonatal period
Secondary Outcome Stillbirth pregnancy
Secondary Outcome Pregnancy loss, stillbirth or neonatal death before discharge pregnancy or neonatal period before discharge
Secondary Outcome Pregnancy loss, stillbirth or neonatal death before 6 weeks pregnancy and 6 weeks postpartum
Secondary Outcome Compliance from enrolment to 20 weeks Proportion taken of expected tablet intake from enrolment to 20 weeks of pregnancy
Secondary Outcome Composite outcome used in previous WHO Calsium trial Severe preeclamptic complications index one or more of outcomes during pregnancy or postpartum period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Harare Hospital Dept of Obstetrics and Gyn, University of Harare Harare Zimbabwe
Chris Hani Baragwanath Hospital University of the Witwatersrand Soweto South Africa
Mowbray Maternity Hospital Private Bag Mowbray Cape Town 7705 South Africa
East London Hospital Complex East London Hospital Complex, Private Bag X9047 East London 5200 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of British Columbia, BMGF Grant 4500 Oak Street, Room B423 Vancouver V6H 3N1 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynaecology East London Hospital Complex, Effective Care Research Unit, PO Box 13484 Vincent, East London 5271 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Susan Fawcus Mowbray Maternity Hosp, Private Bag Mowbray, Cape Town 7705 South Africa
Dr. Siimpiwe Mosi Chris Hani Baragwanath Hospital, University of the Witwaterstrand Soweto, Johannesburg South Africa
Dr Sharla Drebit PRE-EMPT Research Director, Faculty of Medicine, University of British Columbia Vancouver V6K 1B2 Canada
Dr. Peter von Dadelszen Assoc. Prof OB/GYN, Faculty of Medicine, University of British Columbia Vancouver V6K 1B2 Canada
Drs. Eduardo Bergel and Ana Pilar Betran and Ms Mariana Widmer WHO, Dept of Reproductive Health and research Geneva Switzerland
Prof. Stephen Munjanja Department of Obstetrics and Gynaecology, University of Zimbabwe Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justus Hofmeyr justhof@gmail.com 27 43 709 1111 PO Box 13484
City Postal code Country Position/Affiliation
Vincent, East London 5271 South Africa Effective Care Research Unit, East London Hospital Complex
Role Name Email Phone Street address
Public Enquiries GJ Hofmeyr justhof@gmail.com +27 83 280 9402 Frere Maternity Hospital Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Sue Fawcus sfawcus@pgwcc.gov.za 27216595578 Private Bag Mowbray
City Postal code Country Position/Affiliation
Cape Town 7705 South Africa Mowbray Maternity Hospital
Role Name Email Phone Street address
Scientific Enquiries Adegboyega Babatunde Oyebajo oyebajo@gmail.com 27119338156 Chris Hani Road
City Postal code Country Position/Affiliation
Soweto, Johannesburg South Africa
Role Name Email Phone Street address
Scientific Enquiries Stephen P Munjanja pmunjanja@africaonline.co.zw 263 772 516 846 University of Zimbabwe
City Postal code Country Position/Affiliation
Harare Zimbabwe
REPORTING
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