ISRCTN ISRCTN98365455
DOI https://doi.org/10.1186/ISRCTN98365455
Protocol serial number N/A
Sponsor Sodra Alvsaborg’s Hospital (Sweden)
Funder South Alvsborg Research and Development Council (Forskning och Utveckling [FoU]) (Sweden)
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

Primary study designInterventional
Study designDouble blind interventional randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant 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 measure(s)

Blood pressure increase during final weeks of pregnancy

Key secondary outcome measure(s)

Symptoms of pre-eclampsia during final weeks of pregnancy

Completion date01/10/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration60
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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes