Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/10/2008
Prospective/Retrospective
Retrospectively 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

Dr Helen Murphy

ORCID ID

Contact details

The Ipswich Hospital NHS Trust
Diabetes Centre
Heath Road
Ipswich
IP4 5PD
United Kingdom
+44 (0)1473 704759
helen.murphy@ipswichhospital.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0254145814

Study information

Scientific title

Acronym

Study hypothesis

The principal question is whether more detailed assessment of blood glucose levels using the CGMS system will improve glycaemic control throughout pregnancy without an excessive increase in rates of hyperglycaemia and thereby reduce both maternal and perinatal morbidity. In addition this will allow us to assess the relative contribution of different blood glucose parameters I.e. fasting Vs postprandial to measures of glycaemia (HbA1c) and foetal growth throughout gestation and neonatal hyperinsulinsemia. The effects of intensive monitoring on self-efficacy and quality of life will also be measured. We will also examine in more detail then hitherto possible the frequency, severity and management of hypoglycaemia in pregnancy. A detailed economic evaluation of the costs and benefits of the intervention will also be a vital component of this study.

Ethics approval

Not provided at time of registration

Study design

Collaborative, open-label, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

A collaborative, open-label, randomised controlled trial with participants allocated to either standard antenatal care or CGMS which will be performed monthly in addition to standard care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Infants:
1. Perinatal outcome assessed will be gestational age
2. Body weight
3. Respiratory distress (1 and 5 minute apgar scores)
4. Admission to special care baby unit with hypoglycaemia or hyperbilirubinaemia
5. Cord blood measurements of adiposity and hyperinsulineamia

Mothers:
1. Glycaemic control
2. Frequency and severity of hypoglycaemia
3. Presence and /or progression of retinopathy
4. Mode of delivery
5. Delivery related complications
6. Diabetes related distress questionnaire
7. Individually generated index of quality of life measure

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/04/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Target total across all sites = 120.
Inclusion: All women with pre-existing diabetes attending Ipswich or Norwich antenatal diabetes centre.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120 - closed to recruitment

Participant exclusion criteria

None other than serious medical or psychological co-morbidity which would interfere with the subjects ability to participate.

Recruitment start date

08/04/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Ipswich Hospital NHS Trust (UK) NHS R&D Support Funding

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18818254

Publication citations

  1. Results

    Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC, Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial., BMJ, 2008, 337, a1680.

Additional files

Editorial Notes