Treatment of mild gestational diabetes

Metformin treatment vs a diabetes model of antenatal care in women with mild fasting hyperglycaemia diagnosed in pregnancy: a pilot study - Treatment of mild GDM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004065-13-GB

Enrollment

Registered

2013-10-23

Start date

2013-11-27

Completion date

Unknown

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes MedDRA version: 14.1 Level: LLT Classification code 10000138 Term: Abnormal glucose tolerance in pregnancy System Organ Class: 100000004861

Interventions

Trade Name: Metformin hydrochloride Product Name: Metformin hydrochloride Product Code: N/A Pharmaceutical Form: Tablet INN or Proposed INN: Metformin hydrochloride CAS Number: 1115-70-4 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess recruitment rates and acceptability of the proposed trial with particular attention to different ethnic groups;Secondary Objective: 1) Assess compliance in the different intervention arms of the trial 2) Determine the number of women in the intensive arm of the trial who require insulin treatment in addition to metformin based on home blood glucose monitoring 3) Ensure appropriateness and validity of the collection methods of standard clinical outcomes 4) Assess the perceived implications of a diagnosis of GDM in this group using a questionnaire ;Primary end point(s): Recruitment rate and acceptability of intervention.;Timepoint(s) of evaluation of this end point: Three months after recruitment.	—

Measure

Time frame

Main Objective: Assess recruitment rates and acceptability of the proposed trial with particular attention to different ethnic groups;Secondary Objective: 1) Assess compliance in the different intervention arms of the trial 2) Determine the number of women in the intensive arm of the trial who require insulin treatment in addition to metformin based on home blood glucose monitoring 3) Ensure appropriateness and validity of the collection methods of standard clinical outcomes 4) Assess the perceived implications of a diagnosis of GDM in this group using a questionnaire ;Primary end point(s): Recruitment rate and acceptability of intervention.;Timepoint(s) of evaluation of this end point: Three months after recruitment.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Assess compliance in the different intervention arms of the trial 2) Determine the number of women in the intensive arm of the trial who require insulin treatment in addition to metformin based on home blood glucose monitoring 3) Ensure appropriateness and validity of the collection methods of standard clinical outcomes 4) Assess the perceived implications of a diagnosis of GDM in this group using a questionnaire;Timepoint(s) of evaluation of this end point: Within six months of recruitment of final woman.	—

Measure

Time frame

Secondary end point(s): 1) Assess compliance in the different intervention arms of the trial 2) Determine the number of women in the intensive arm of the trial who require insulin treatment in addition to metformin based on home blood glucose monitoring 3) Ensure appropriateness and validity of the collection methods of standard clinical outcomes 4) Assess the perceived implications of a diagnosis of GDM in this group using a questionnaire;Timepoint(s) of evaluation of this end point: Within six months of recruitment of final woman.

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Countries

United Kingdom

Contacts

Public ContactResearch Office

Central Manchester University Hospitals NHS Foundation Trust

research.secretary@cmft.nhs.uk+44161 2763565

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026