Does supplementation of extra Magnesium daily to first time pregnant healthy women prevent blood pressure increase during pregnancy?
| ISRCTN | ISRCTN13890849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13890849 |
| Secondary identifying numbers | Mg400 |
- Submission date
- 23/04/2018
- Registration date
- 27/04/2018
- Last edited
- 16/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Public
Edenhjelms väg 33b
Lerum
44339
Sweden
 ORCID ID |
0000-0002-3954-7228 |
|---|---|
| Phone | +46706257092 |
| maria.bullarbo@vgregion.se |
Study information
| Study design | Placebo-controlled double-blind interventional multicenter study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Magnesium supplementation and blood pressure in pregnancy - a double-blind randomized multicenter study |
| Study objectives | 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(s) | Central Ethics Review Board University of Gothenburg Sweden, 07/08/2014, ref: Dnr578-14 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2014 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Nulliparity 2. No regular medication 3. Normotension 4. Singleton pregnancy 5. Maternity age >18 years and < 40 years |
| Key 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 |
| Date of first enrolment | 15/08/2014 |
| Date of final enrolment | 15/01/2017 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Borås
503 38
Sweden
Alingsås
441 83
Sweden
Trollhättan
461 32
Sweden
Sponsor information
Industry
Adalperostrasse 37
Ismaning
85737
Germany
| Website | www.protina.de |
|---|
Funders
Funder type
Research council
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in Journal of Pregnancy, already submitted for consideration. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/05/2018 | Yes | No |
Editorial Notes
16/07/2018: Publication reference added.
