Contact information
Type
Scientific
Primary contact
Prof Ragnar Rylander
ORCID ID
Contact details
Bjorkasvagen 21
Lerum
443 91
Sweden
+46 (0)708 40 0101
envhealth@biofact.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acid-base balance and blood pressure during pregnancy: a double-blinded randomized controlled trial
Acronym
Study hypothesis
Intervention with magnesium citrate will prevent increase in blood pressure during last part of pregnancy.
Further reading: http://www.ncbi.nlm.nih.gov/pubmed/20135136.
Ethics approval
The Gothenburg Committee, 08/03/2009, ref: 098-09
Study design
Double blind interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Pregnancy
Intervention
Magnesium citrate powder (Diasporal), 12 mmol magnesium daily, taken at week 25 of pregnancy until delivery.
Control group receive no supplements. Blood pressure and proteinurea are measured routinely in all pregnancies
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Blood pressure increase during final weeks of pregnancy
Secondary outcome measures
Symptoms of pre-eclampsia during final weeks of pregnancy
Overall trial start date
01/10/2010
Overall trial end date
01/10/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. First time pregnancies
2. Urinary calcium excretion in excess of 6 mmol around pregnancy week 20
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
History of blood pressure or renal dysfunction
Recruitment start date
01/10/2010
Recruitment end date
01/10/2012
Locations
Countries of recruitment
Sweden
Trial participating centre
Bjorkasvagen 21
Lerum
443 91
Sweden
Sponsor information
Organisation
Sodra Alvsaborgs Hospital (Sweden)
Sponsor details
Maternity care unit
Boras
501 82
Sweden
+46 (0)33 616 0000
Mats.elm@vgregion.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
South Alvsborg Research and Development Council (Forskning och Utveckling [FoU]) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23715924
Publication citations
-
Results
Bullarbo M, Ödman N, Nestler A, Nielsen T, Kolisek M, Vormann J, Rylander R, Magnesium supplementation to prevent high blood pressure in pregnancy: a randomised placebo control trial., Arch. Gynecol. Obstet., 2013, 288, 6, 1269-1274, doi: 10.1007/s00404-013-2900-2.