Outcome of women with early gestational glucose intolerance treated with medical nutrition therapy and metformin versus only medical nutrition therapy randomised control trial

INTRODUCTION

Hyperglycaemia is now one of the most common medical conditions seen during pregnancy. Recent study has emphasized that if pregnant women have PPBS >110 mg/dl, MNT and metformin 250 mg twice a day should be started before 9 weeks and continued for achieving the target PPBG to less than 110 mg/dl.

JUSTIFICATION FOR STUDY

It is hypothesized that Metformin therapy initiated at 8 weeks will also help to prevent progression to higher thresholds of dysglycemia and prevent development of GGI and GDM in more number of patients as compared to the MNT only group.

• Therefore, this study is planned to compare proportion of women with EGGI on MNT who develop GGI or GDM with and without metformin therapy.

RESEARCH QUESTION

Does addition of metformin to MNT prevent conversion to GGI or GDM in women with early gestational glucose intolerance comparison to MNT alone?

HYPOTHESIS

Addition of metformin to MNT prevents conversion to GGI or GDM in women with early gestational glucose intolerance in comparison to  MNT alone

OBJECTIVES

 Primary Objective

To compare proportion of women with EGGI who develop GGI or GDM in the MNT +Metformin group versus only MNT group,

Secondary Objective-

To compare proportion of women who develop following fetomaternal complications in both groups

• Foetal outcome-LGA, FGR, preterm subcutaneous thickness ponderal index, proportion of newborns with admission in nursery or NICU, stillbirths, early neonatal deaths

• Maternal outcome-Hypertensive disorders of pregnancy, caesarean deliveries, polyhydramniosshoulder dystocia, weight gain during pregnancy

MATERIAL AND METHODS

 Study design: Randomised control trial

 Study period: April 2024 to September 2025

 Place of study: Department of obstetrics and gynaecology Lady Hardinge Medical College and Smt.

Suchetha Kriplani hospital

Study population: Pregnant women with period of gestation below 9 weeks gestation

 Study place: Department of Obstetrics and Gynaecology, LHMC & SSKH

 INCLUSION CRITERIA

Pregnant women with period of gestation < 9week gestation having early gestational glucose intolerance with PPBS>110mg/dl and <120 mg /dl

EXCLUSION CRITERIA

1. Women with pre-existing diabetes mellitus

2. Women with PCOS on metformin therapy

3. Women who are having bleeding or pain in abdomen

4. Women with known case of chronic medical disorder such as hypertension, chronic liver disease,      cardiovascular diseases,

5. Active infection like TB, HIV, malaria, other febrile illness

6. Multiple pregnancy

METHODOLOGY

After approval from the ECHR and CRTI registration women below 9 weeks period of gestation will undergo screening by thorough history and examination

                                                                    All recruited pregnant women will undergo testing for 2-hours PPBS at 8-9 weeks and with women PPBS>110mg/dl and <120mg/dl will be recruited in the study after a written informed consent

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Recruited women will be allocated into 2 groups according to computer generated block random numbers

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Concealed allocation will be done in sealed envelopes by a colleague not directly involved in the study into 2 groups

Group 1 -Intervention group- MNT with Metformin 250mgBD/day

Group 2- Non Intervention group- MNT

                                                                        

All recruited women will undergo 2-hour PPBS at 11-12 weeks and undergo GDM screening by DIPSI test during 14-16th week, 24-28 weeks and 32-34 weeks as per DIPSI guidelines. If found to be GDM at any visit, she will be treated with standard treatment.

OUTCOME PARAMETERS

Primary Outcome Parameter : To compare proportion of women with EGGI who develop GGI or GDM in the MNT +Metformin group versus only MNT group

Secondary Outcome Parameters

To compare proportion of women who develop following fetomaternal complications in both groups

• Fetal outcome-LGA ,FGR, preterm ,subcutaneous thickness ponderal index ,proportion of newborns with admission in nursery or NICU, stillbirths, early neonatal deaths

• Maternal outcome-Hypertensive  disorders of pregnancy, caesarean deliveries, polyhydromnios shoulder dystocia, weight gain during pregnancy