Preventing Recurrent Gestational Diabetes Mellitus with Early Metformin Intervention

Preventing Recurrent Gestational Diabetes Mellitus with Early Metformin Intervention - Preventing Recurrent Gestational Diabetes with Metformin

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001244-38-GB

Enrollment

112

Registered

2014-05-23

Start date

2014-07-16

Completion date

Unknown

Last updated

2015-03-16

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

Conditions

Gestational diabetes mellitus. MedDRA version: 17.1 Level: LLT Classification code 10018210 Term: Gestational diabetes mellitus System Organ Class: 100000004868

Interventions

Product Name: Metformin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Metformin hydrochloride CAS Number: 657-24-9 Concentration unit: mg milligram(s) Pharmaceutical form of the placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed singleton viable pregnancy 2. Between 8 and 22 weeks gestation 3. History of a previous pregnancy complicated by gestational diabetes mellitus 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 112 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Established pre-existing diabetes (including unrecognised diabetes defined as FPG = 7.0mmol/L and/ or HbA1c = 48mmol/mol) 2. Contraindications to metformin therapy a. Renal impairment: creatinine = 130µmol/L b. Impaired liver function (ALT = 2.0 x upper limit normal) c. Previous intolerance to metformin 3. Planned continued antenatal care/ delivery at centre not included in trial 4. Planned fast for cultural/ religious reasons e.g. Ramadan

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to ascertain if intervention with metformin therapy early in pregnancy prevents recurrent gestational diabetes mellitus (GDM) in women with a history of pregnancies previously complicated by GDM. ;Secondary Objective: The secondary objectives are to evaluate the effect of early metformin intervention on the following: • Maternal factors (weight gain, requirement for insulin therapy, post-partum glucose measurements and levels of health and satisfaction). • Neonatal features (fetal birthweight/ birthweight centile and a composite of outcomes related to complications of gestational diabetes) • Cost effectiveness in the prevention of GDM. ;Primary end point(s): The primary outcome is development of gestational diabetes mellitus at any point during pregnancy.;Timepoint(s) of evaluation of this end point: An 75g oral glucose tolerance test will be conducted at 28 weeks gestation and a diagnosis of GDM will be made if the IADPSG criteria are fulfilled (i.e. fasting plasma glucose > 5.1mmol/L or 2 hour post-glucose load > 8.5mmol/L). Assessments of glucose tolerance will otherwise be ongoing from 18 weeks till 36 weeks gestation. Women will be instructed to monitor their capillary glucose values at home. On each of their two weekly clinic attendances, a fasting plasma glucose will be measured. If values are elevated, a diagnostic 75g oral glucose tolerance test will be completed.	—

Measure

Time frame

Main Objective: The primary objective is to ascertain if intervention with metformin therapy early in pregnancy prevents recurrent gestational diabetes mellitus (GDM) in women with a history of pregnancies previously complicated by GDM. ;Secondary Objective: The secondary objectives are to evaluate the effect of early metformin intervention on the following: • Maternal factors (weight gain, requirement for insulin therapy, post-partum glucose measurements and levels of health and satisfaction). • Neonatal features (fetal birthweight/ birthweight centile and a composite of outcomes related to complications of gestational diabetes) • Cost effectiveness in the prevention of GDM. ;Primary end point(s): The primary outcome is development of gestational diabetes mellitus at any point during pregnancy.;Timepoint(s) of evaluation of this end point: An 75g oral glucose tolerance test will be conducted at 28 weeks gestation and a diagnosis of GDM will be made if the IADPSG criteria are fulfilled (i.e. fasting plasma glucose > 5.1mmol/L or 2 hour post-glucose load > 8.5mmol/L). Assessments of glucose tolerance will otherwise be ongoing from 18 weeks till 36 weeks gestation. Women will be instructed to monitor their capillary glucose values at home. On each of their two weekly clinic attendances, a fasting plasma glucose will be measured. If values are elevated, a diagnostic 75g oral glucose tolerance test will be completed.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Maternal outcomes: A. Gestational weight gain B. Requirement for insulin therapy during pregnancy C. Six-week maternal postpartum glucose D. Levels of physical and psychological health/ satisfaction 2. Fetal outcomes: A. Fetal birthweight B. Fetal birthweight centile C. Composite of neonatal outcomes (hypoglycaemia, birth trauma, respiratory distress syndrome, birth related injuries) 3. Cost effectiveness analysis ;Timepoint(s) of evaluation of this end point: 1. Maternal outcomes: A. Gestational weight gain: Difference between weight measured at initial study visit (8-22 weeks gestation) and 36 week study visit. B. Review of glycaemic parameters will be ongoing throughout pregnancy from 18 weeks gestation. If GDM is diagnosed, treatment will be established as per clinician preference (either metformin and/or insulin). C. Maternal postpartum glucose: 6 weeks post delivery. D. Levels of physical and psychological health/ satisfaction: Screening (8-22 weeks gestation), the 28 week clinic visit, 36 week visit and 6 weeks postpartum. 2. Fetal outcomes: All will be assessed in the immediate postpartum period. 3. Cost effectiveness analysis: Screening (8-22 weeks gestation), the 28 week clinic visit, 36 week visit and 6 weeks postpartum.	—

Measure

Time frame

Secondary end point(s): 1. Maternal outcomes: A. Gestational weight gain B. Requirement for insulin therapy during pregnancy C. Six-week maternal postpartum glucose D. Levels of physical and psychological health/ satisfaction 2. Fetal outcomes: A. Fetal birthweight B. Fetal birthweight centile C. Composite of neonatal outcomes (hypoglycaemia, birth trauma, respiratory distress syndrome, birth related injuries) 3. Cost effectiveness analysis ;Timepoint(s) of evaluation of this end point: 1. Maternal outcomes: A. Gestational weight gain: Difference between weight measured at initial study visit (8-22 weeks gestation) and 36 week study visit. B. Review of glycaemic parameters will be ongoing throughout pregnancy from 18 weeks gestation. If GDM is diagnosed, treatment will be established as per clinician preference (either metformin and/or insulin). C. Maternal postpartum glucose: 6 weeks post delivery. D. Levels of physical and psychological health/ satisfaction: Screening (8-22 weeks gestation), the 28 week clinic visit, 36 week visit and 6 weeks postpartum. 2. Fetal outcomes: All will be assessed in the immediate postpartum period. 3. Cost effectiveness analysis: Screening (8-22 weeks gestation), the 28 week clinic visit, 36 week visit and 6 weeks postpartum.

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Countries

United Kingdom

Outcome results

None listed

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