Treatment of mild gestational diabetes

• Conditions: Gestational diabetes; MedDRA version: 14.1Level: LLTClassification code 10000138Term: Abnormal glucose tolerance in pregnancySystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-004065-13-GB
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-23
• Last Update Posted: 6 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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. Women with mild fasting hyperglycaemia (5.1-5.4 mmol/L, 2 hour <8.5 mmol/L) will be invited to take part in the study by telephone and invited to attend an appointment (telephone interpretation services will be used where English is not the first language).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Multiple pregnancy
Previous stillbirth
Previous shoulder dystocia
Age under 16
Incapacity to consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified