Condition category
Pregnancy and Childbirth
Date applied
23/04/2018
Date assigned
27/04/2018
Last edited
16/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High blood pressure during pregnancy is a risk factor for developing pre-eclampsia (high blood pressure, causing large amounts of protein in urine or other organ dysfunction), which can lead to onset of seizures, known as eclampsia (E). It affects approximately 6-8% of all pregnant women.
A blood pressure of 140/90 mmHg is defined as gestational hypertension (HT). The cause of HT is depends on a number of factors, such as but nulliparity (never given birth before), obesity, stress, genetics, high maternal age, multiple pregnancy, diabetes, thrombophilia (increased tendency for blood clotting), kidney disease, chronic HT and nutritional deficiency.
When HT is accompanied by abnormal amounts of protein in the urine (proteinuria) of at least 0.3g/day, it is defined as pre-eclampsia. Little is known about efficient preventive treatment against BP increase during pregnancy, but some study reports support the suggestion that Magnesium supplementation could have a preventive effect.
This study aims to investigate the effect of magnesium supplementation in healthy pregnant women for prevention of blood pressure increase.

Who can participate?
Pregnant women aged 18 – 40 years who have not given birth before.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive 400mg Magnesium Extra, Diasporal® supplement, taken daily. Those in the second group take a placebo (dummy pill) daily.
Participants have their blood pressure measured throughout pregnancy, and blood samples taken at weeks 12-14 and 35.
Labour and fetal outcomes are recorded from medical records at delivery.

What are the possible benefits and risks of participating?
Supplementation of magnesium during pregnancy could possibly prevent blood pressure increase in late pregnancy, which about 10% of first time pregnant women suffer from. Participants may be at risk from possible side effects such as abdominal pain, diarrhea and nausea, but none considered hazardous to the pregnant women. No negative effects have been reported regarding the fetus.

Where is the study run from?
1. Antenatal care unit (ACU) in Borås (Sweden)
2. Antenatal care unit in Alingsås (Sweden)
3. Antenatal care unit in Trollhättan (Sweden)

When is the study starting and how long is it expected to run for?
January 2014 to December 2018

Who is funding the study?
1. Lokala FoU rådet SÄS (Sweden)
2. The Research and Development Foundation at Region Halland (Sweden)

Who is the main contact?
Dr Maria Bullarbo (Scientific)
maria.bullarbo@vgregion.se

Trial website

Contact information

Type

Public

Primary contact

Mrs Maria Bullarbo

ORCID ID

http://orcid.org/0000-0002-3954-7228

Contact details

Edenhjelms väg 33b
Lerum
44339
Sweden
+46706257092
maria.bullarbo@vgregion.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Mg400

Study information

Scientific title

Magnesium supplementation and blood pressure in pregnancy - a double-blind randomized multicenter study

Acronym

Study hypothesis

The primary aim of the study is to investigate whether a daily supplementation with 400 mg Mg during pregnancy compared to a placebo group in a double-blind setting could prevent an increase of diastolic BP of at least 15 mm Hg. Secondary outcomes are comparison of biomarkers for hypertensive disorders, labour and fetal outcomes between the groups.

Ethics approval

Central Ethics Review Board University of Gothenburg Sweden, 07/08/2014, ref: Dnr578-14

Study design

Placebo-controlled double-blind interventional multicenter study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Blood pressure in pregnancy

Intervention

After oral and written consent, participants are randomised in a computerised double-blind procedure to receive either Mg (400 mg Magnesium Extra, Diasporal®) or placebo, taken daily. The code is not broken until all participants have given birth.
Data is collected throughout pregnancy and from medical records after delivery. There is no further patient follow up after delivery.
Blood samples are collected at gestational weeks 12–14 and 35 for analysis of IL-6, CRP, urate, cystatin C, Mg, Ca, albumin, creatinine and glomerular filtration rate (GFR). Blood pressure (BP) is measured at the ACU at 2–3 week intervals throughout the pregnancy, with the women seated with arm- and backrest support, down to Korotkoff V with a manual sphygmomanometer. BP data registered at the ACU and labour ward are collected from medical records. Records are obtained on gestational length at birth, labour outcomes including excessive bleeding >1000 ml, instrumental delivery, duration of active labour, and fetal outcomes including Apgar score at five minutes, pH in the arterial umbilical cord, birth weight and need of care at a neonatal intensive care unit (NICU).

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Blood pressure is measured using manual sphygmomanometer at 2-3 week intervals throughout the pregnancy, and obtained from medical records at labour.

Secondary outcome measures

1. Biomarkers for hypertensive disorders ( IL-6, CRP, urate, cystatin C, Mg, Ca, albumin, creatinine and glomerular filtration rate (GFR) are analysed from blood samples at gestational weeks 12-14 and 35.
2. Labour and foetal outcomes (gestational length at birth, excessive bleeding >1000 ml, instrumental delivery, duration of active labour, Apgar score at five minutes, pH in the arterial umbilical cord, birth weight and need of care at a neonatal intensive care unit) are collected from medical records after delivery.

Overall trial start date

01/01/2014

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Nulliparity
2. No regular medication
3. Normotension
4. Singleton pregnancy
5. Maternity age >18 years and < 40 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Age <18 or >40 years
2. Multiple pregnancy
3. Trombophilia
4. Previous labour
5. Diabetes
6. Chronic HT
7. Kidney disease
8. Heart disease
9. Regular medication
10. History of cardiac arrhythmia
11. Heredity of sudden cardiac arrest

Recruitment start date

15/08/2014

Recruitment end date

15/01/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Antenatal care unit (ACU) in Borås
Bryggaregatan 5
Borås
503 38
Sweden

Trial participating centre

Antenatal care unit in Alingsås
Oscarsgatan 9 B
Alingsås
441 83
Sweden

Trial participating centre

Antenatal care unit in Trollhättan
Drottninggatan 38 A
Trollhättan
461 32
Sweden

Sponsor information

Organisation

Protina Pharmazeutische GmbH

Sponsor details

Adalperostrasse 37
Ismaning
85737
Germany

Sponsor type

Industry

Website

www.protina.de

Funders

Funder type

Research council

Funder name

Lokala FoU rådet SÄS (Diarienummer: VGFOUSA-420031)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Research and Development Foundation at Region Halland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in Journal of Pregnancy, already submitted for consideration.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

30/06/2018

Participant level data

Other

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30002931

Publication citations

Additional files

Editorial Notes

16/07/2018: Publication reference added.