Condition category
Pregnancy and Childbirth
Date applied
23/08/2010
Date assigned
14/09/2010
Last edited
05/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 Alvsaborg’s 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

  1. 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.

Additional files

Editorial Notes