Management of Mild Gestational Diabetes Mellitus (GDM)

Not Applicable

Completed

• Conditions: Gestational Diabetes; Pregnancy and Childbirth; Diabetes mellitus arising in pregnancy

• Registration Number: ISRCTN86503951
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust (UK)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33243030/ (added 30/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-08
• Study Completion: 2014-12-31
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Women with risk factors for GDM (NICE 2008) will be offered an oral glucose tolerance test (OGTT) at 26 weeks gestation as part of their routine antenatal care. Women will be provided with written information regarding the study at the time of the OGTT.
2. Women with mild fasting hyperglycaemia (5.1-5.4 mmol/L, 2 hour <8.5 mmol/L) will be invited to participate.

Exclusion Criteria

1. Multiple pregnancy
2. Previous still-birth
3. Previous shoulder dystocia requiring obstetric manoeuvres
4. Age under 16
5. Incapacity to consent
6. A known hypersensitivity to metformin hydrochloride or to any of the excipients
7. Contra-indication to Metformin
8. Known abnormalities of the liver (tested at randomisation)
9. Renal failure or renal dysfunction
10. Acute conditions with the potential to alter renal function such as:
10.1. Dehydration
10.2. Severe infection
10.3. Shock
10.4. Intravascular administration of iodinated contrast agents
11. Acute or chronic diseases which may cause tissue hypoxia such as:
11.1. Cardiac or respiratory failure
11.2. Recent myocardial infarction
11.3. Shock
11.4. Hepatic insufficiency, acute alcohol intoxication, alcoholism
12. Lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified