Condition category
Pregnancy and Childbirth
Date applied
03/01/2018
Date assigned
15/01/2018
Last edited
07/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Gestational diabetes mellitus (GDM) is a condition with raised glucose (blood sugar) levels that is first diagnosed in pregnancy. It increases the risk of complications for mothers and their babies. There is a need for an effective, simple, acceptable and safe treatment to prevent gestational diabetes, which affects 1800 women every year in Barts Health Trust alone. To date, small studies have found that the over-the-counter nutritional supplement myo-inositol may reduce the risk of GDM. The uptake of this in mothers from inner city NHS trusts, which care for multi-ethnic, high-risk women, is not known. The aim of this small study (200 women) is to test the effectiveness of myo-inositol at preventing GDM before investing resources into a large-scale study (approx. £1.7 million).

Who can participate?
Women with a single pregnancy and at least one of the following risk factors: family history of diabetes, gestational diabetes in a previous pregnancy, obesity, minority ethnic family origin with a high prevalence of diabetes (such as South Asian, Middle Eastern and Black Caribbean), polycystic ovary syndrome, or previous macrosomic baby (birth weight over 4.5 kg)

What does the study involve?
Participants are randomly allocated to take a sachet of powder dissolved in water containing either myo-inositol or a placebo (dummy) supplement twice daily until delivery. Follow-up visits take place at 20, 28 and 34 weeks and delivery, aligning with the routine antenatal appointments. The study process is evaluated to examine the acceptability of the study and intervention to mothers, and identify reasons for non-participation and non-retention. The effects of myo-inositol on blood sugar are also estimated.

What are the possible benefits and risks of participating?
The results of this study will aid the development of further studies examining the effect of myo-inositol on the risk of GDM. Both supplements are vegan friendly. It is safe to continue any other nutritional supplements women may already be taking along with the study supplements. The potential for pain, discomfort, distress, inconvenience or changes to lifestyle as a result of participating in this study should be minimal. Taking the supplements might be a burden but research suggests that women are willing to take a daily nutritional supplement.

Where is the study run from?
1. Royal London Hospital (UK)
2. Newham University Hospital (UK)
3. Whipps Cross University Hospital (UK)
4. Manchester Royal Infirmary (UK)
5. St Thomas’ Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2017 to April 2019

Who is funding the study?
1. Barts and the London Charity and Related Charities
2. NIHR CLAHRC North Thames
3. Pharmasure Ltd

Who is the main contact?
Dr Zoe Drymoussi

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zoe Drymoussi

ORCID ID

Contact details

Yvonne Carter Building
58 Turner Street
London
E1 2AB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35832

Study information

Scientific title

Effectiveness and acceptability of myo-inositol nutritional supplement in the prevention of gestational diabetes: a pilot placebo-controlled double-blind randomised trial

Acronym

EMmY

Study hypothesis

Gestational diabetes, a condition with raised glucose levels that is first diagnosed in pregnancy, increases the risk of complications to mothers and their babies. There is a need for an effective, simple, acceptable and safe treatment to prevent gestational diabetes, which affects 1800 women every year in Barts Health Trust alone. Our systematic review identified the promising role of the nutritional supplement myo-inositol in reducing the risk of GDM. To date, small studies have identified the potential role of over-the-counter nutritional supplement myo-inositol in preventing gestational diabetes. The uptake of the intervention in mothers from inner city NHS trusts, which care for multi-ethnic, high-risk women is not known.

Prior to investing resources into a large-scale study (approx. £1.7 million) on testing the effectiveness of myo-inositol to reduce the incidence of GDM, we propose to undertake a smaller version (200 women) of the future large trial. The trialists propose to undertake a multi centre, randomised, placebo controlled, double blind pilot trial (EMmY), on myo-inositol supplementation in pregnancy to prevent GDM, to inform the large-scale definitive randomised trial. They will evaluate the study process, examine the acceptability of the study and intervention to mothers, and identify reasons for non-participation and non-retention. They will also obtain preliminary estimates of effects of myo-inositol on glycaemic parameters, and develop a core outcome set to be minimally reported in trials on prevention of GDM.

Ethics approval

London – Queen Square Research Ethics Committee, 22/12/2017, ref: 17/EM/0394

Study design

Randomised; Interventional; Design type: Prevention, Dietary

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: Maternal/ Fetal medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other maternal disorders predominantly related to pregnancy, Metabolic and Endocrine/ Diabetes mellitus

Intervention

Randomisation will be done using an online system with a randomisation scheme based on permuted blocks of random block size (sizes 4, 6 and 8), stratified by participating site. No adaptive or minimisation strategies will be used in this trial.

The treatment arm will receive myo-inositol, and the control arm will receive a placebo. In both arms, the supplements are to be taken twice daily, from 12+0 to 15+6 weeks until delivery. After recruitment and randomisation, follow-up visits will be at 20 weeks, 28 weeks, 34 weeks, and delivery, aligning with the routine antenatal appointments.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Process outcomes for the feasibility study:
1. Proportion of screened women who are eligible
2. Proportion of eligible women who are consented and randomised
3. Attrition rates at 28 weeks of pregnancy, and up to delivery
4. Adherence to treatment and to protocol
5. Deviations from the study protocol
6. Completeness of data collection
7. Determination of level of support required for the trial conduct
Timepoint(s): End of the study

Secondary outcome measures

Acceptability of the study and intervention assessed through qualitative research interviews and questionnaires, aimed at the participants, those who refuse consent to the study, and healthcare professionals involved in the study. Women who decline trial participation are offered an optional short open-ended questionnaire to capture any reasons. Interviews with participants will be carried out in a small proportion (approx. 10-20 women), at around 20 weeks and 34 weeks of pregnancy. Interviews with 10-15 healthcare professionals are carried out towards the end of the study.

Preliminary estimates of the effect of the intervention:
1. Clinical outcomes for mother and baby are collected from their medical notes at delivery
2. Laboratory outcomes of glucose metabolism tests, including an Oral Glucose Tolerance Test, are collected at the 28-week visit
3. Cost data including that of the intervention, lab tests, and clinic visits are assessed throughout the study
4. QALYs are assessed through the EQ-5D-5L questionnaire administered at baseline and delivery

Overall trial start date

01/09/2017

Overall trial end date

01/04/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with a singleton, viable pregnancy between 12+0 and 15+6 weeks gestation, based on ultrasound confirmation
2. Women with at least one of the following risk factors: family history of diabetes in any one of their first degree relatives, gestational diabetes in a previous pregnancy, obesity (BMI ≥30 Kg/m2), minority ethnic family origin with a high prevalence of diabetes (such as South Asian, Middle Eastern and Black Caribbean), polycystic ovary syndrome, or previous macrosomic baby (birth weight >4.5 kg)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 250; UK Sample Size: 250

Participant exclusion criteria

1. Women known to have pre-existing type 1 or type 2 diabetes
2. Women considered to have undiagnosed type 2 diabetes, based on abnormal glycated haemoglobin (A1c) (HbA1c) levels and/or OGTT results before 15+6 weeks of pregnancy. Abnormal HbA1c levels defined as > = 48mmol/mol. Abnormal OGTT results defined as a fasting blood glucose level of > = 5.6mmol/l, or a 75g 2-hour blood glucose level of > = 7.8 mmol/l
3. Women using corticosteroids or metformin
4. Women who are not able to provide written informed consent in English

Recruitment start date

01/02/2018

Recruitment end date

31/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal London Hospital
Whitechapel Road
London
E1 1BB

Trial participating centre

Newham University Hospital
Glen Road Plaistow
London
E13 8SL

Trial participating centre

Whipps Cross University Hospital
Whipps Cross Road Leytonstone
London
E11 1NR

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL

Trial participating centre

St Thomas’ Hospital
Westminster Bridge Road
London
SE17 7EH

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Mile End Road
London
E1 4NS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Barts and the London Charity and Related Charities; Grant Codes: MGU0373

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR CLAHRC North Thames

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pharmasure Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol is currently being prepared for publication. There are no plans at present to make available additional documents. The results from the trial will be submitted for publication in a major journal; it is anticipated that this will be within one year after the trial end date. The trialists will also disseminate their findings through their current social media links to provide lay and scientific bite-size summaries of the study results. They will disseminate the findings to local pregnancy support groups via members of Katie’s Team (our patient and public involvement advisory group).

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/02/2018: Sponsor address added.