ISRCTN ISRCTN98365455
DOI https://doi.org/10.1186/ISRCTN98365455
Secondary identifying numbers N/A
Submission date
23/08/2010
Registration date
14/09/2010
Last edited
05/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ragnar Rylander
Scientific

Bjorkasvagen 21
Lerum
443 91
Sweden

Phone +46 (0)708 40 0101
Email envhealth@biofact.se

Study information

Study designDouble blind interventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleAcid-base balance and blood pressure during pregnancy: a double-blinded randomized controlled trial
Study objectivesIntervention 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(s)The Gothenburg Committee, 08/03/2009, ref: 098-09
Health condition(s) or problem(s) studiedPregnancy
InterventionMagnesium 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 typeOther
Primary outcome measureBlood pressure increase during final weeks of pregnancy
Secondary outcome measuresSymptoms of pre-eclampsia during final weeks of pregnancy
Overall study start date01/10/2010
Completion date01/10/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants60
Key inclusion criteria1. First time pregnancies
2. Urinary calcium excretion in excess of 6 mmol around pregnancy week 20
Key exclusion criteriaHistory of blood pressure or renal dysfunction
Date of first enrolment01/10/2010
Date of final enrolment01/10/2012

Locations

Countries of recruitment

  • Sweden

Study participating centre

Bjorkasvagen 21
Lerum
443 91
Sweden

Sponsor information

Sodra Alvsaborg’s Hospital (Sweden)
Hospital/treatment centre

Maternity care unit
Boras
501 82
Sweden

Phone +46 (0)33 616 0000
Email Mats.elm@vgregion.se
ROR logo "ROR" https://ror.org/01qas6g18

Funders

Funder type

Research council

South Alvsborg Research and Development Council (Forskning och Utveckling [FoU]) (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2013 Yes No