WHO randomized trial of calcium supplementation before pregnancy to reduce recurrent pre-eclampsia

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201105000267371
• Date of registration: 06/12/2010
• Primary sponsor: Department of Obstetrics and Gynaecology
• Public title: WHO randomized trial of calcium supplementation before pregnancy to reduce recurrent pre-eclampsia
• Scientific title: WHO randomized trial of calcium supplementation before pregnancy to reduce recurrent pre-eclampsia
• Date of first enrolment: 2011-01-17
• Target sample size: Nil
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201105000267371
• Study type: interventional
• Study design: 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 ,

Countries of recruitment

South Africa

Contacts

• Name: Sue Fawcus
• Affiliation: Mowbray Maternity Hospital

• Name: Natalia Novikova
• Affiliation: Effective Care Research Unit, East London Hospital Complex;

Key inclusion & exclusion criteria

Inclusion criteria: 1.Previous pre-eclampsia or eclampsia in most recent pregnancy
2. Planning to get pregnant

Exclusion criteria: 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


Age minimum: 18 Year
Age maximum: 45 Year
Gender: Female

Health Condition(s) or Problem(s) studied

calcium supplementation for pre-eclampsia

Primary Outcome(s)

Pre-eclampsia

Pre-eclampsia or pregnancy loss before labor at any gestation

Severe maternal morbidity and mortality index: defined as one or more of the secondary outcomes

Secondary Outcome(s)

Apgar score less than 7 at five minutes

Birthweight less than 2500g

Caesarean Section

Cerebrovascular accident

Compliance from enrolment to 20 weeks

Composite outcome used in previous WHO Calsium trial

Death or admission ot neonatal unit ICU for 24 hours or more

Early onset pre-eclampsia (at less than 32 weeks)

Early preterm birth less than 32 weeks gestation

Ecplampsia

Gestational hypertension

Gestational proteinuria

HELLP Syndrome

ICU admission greater than 24 hours

Liver failure defined as AST greater than or equal to 70 U per L

maternal death

Moderately severe thrombocytopenia

Mothers hospital stay lasts 7 days or more after birth

No conception during study period

Placental abruption

Pregnancy loss before labour

Pregnancy loss, stillbirth or neonatal death before 6 weeks

Pregnancy loss, stillbirth or neonatal death before discharge

Preterm birth less than 37 weeks gestation

Pulmonary oedema

Renal Failure defined as creatinine greater than or equal to 120mmol per liter

Severe gestational hypertension

Severe pre-eclampsia

Stillbirth

Uric acid greater or equal to values for gestational age

Secondary ID(s)

A65750

M10977

South African National Clinical Trial Registry

Source(s) of Monetary Support

University of British Columbia, BMGF Grant