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Professional Med J 2015;22(10): 1298-1303. www.theprofesional.com

GESTATIONAL DIABETES

1298

The Professional Medical Journal

www.theprofesional.com

GESTATIONAL DIABETES;TO COMPARE THE EFFICACY OF METFORMIN WITH INSULIN INDIABETES MELLITUS IN TERMS OF FETOMATERNAL OUTCOME

Tayyaba Majeed1, Rabia Adnan2, Irum Mubshar3, Hamis Mahmood4, Kanwal Saba5,

Sardar Fakhar Imam6, Muhammad Al-Fareed Zafar7, Mulazim Hussain Bukhari8

ORIGINAL PROF-3019

ABSTRACT Objectives: To compare the efcacy of Metformin with insulin in gestationaldiabetes mellitus in terms of fetomaternal outcome. Study Deign: Randomized clinical

trial study. Setting: Lady Aitchison Hospital Lahore. Period:January 2014 to March 2015.Methodology: Total 500 pregnant females with GDM were included in the study through non-probability, consecutive sampling. Patients were divided into 2 equal groups (A: B). Patientsin group A were given tablet metformin 500 mg by oral route and group B was administratedregular injection Insulin by subcutaneous route. Results: The mean age of females was32.146.13 years. The mean gestational age was 31.073.8 weeks. There were 78 (15.6%)females who had 0 parity, 107 (21.4%) females had parity 1, 175 (35%) females had parity2, 95 (19%) females had parity 3, 33 (6.6%) females had parity 4 and 12 (2.4%) females

had parity 5.There were 54 (10.8%) cases had PTB, out of which 12 (4.8%) had PTB withmetformin while 42 (16.8%) had PTB with insulin. There were 115 (23%) neonates requiredNICU admission, out of which 37 (14.8%) neonates with metforminand78 (31.2%) neonateswith insulin. There were 87 (17%) neonates who had neonatal hypoglycemia, out of which23 (9.2%) neonates with metformin and64 (25.6%) neonates with insulin. The difference wassignicant between both groups for all fetal outcomes (P


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decrease the incidence of fetomaternal complica-tions. The previous study has shown thataggres-sive management in women with GDMreduced

birth weight and macrosomia in infants borntomothers who were exposed to the interventioncompared with women who had received routine

care.6

Therefore, measures such as dietary modi-cation, exercise, oral hypoglycemic agents, andinsulin are imperative to reduce the complica-

tions.7

When the above-mentioned measures do notfulll the criteria to control blood glucose levelsin pregnant women, the use of subcutaneous in-

sulin therapy is the standard approach for man-agement of GDM.8,9,10 However, insulin use hasits own set of problems including multiple daily

injections, the risk of hypoglycemia and maternalweight gain.11 It needs to be altered dependingon the patients weight and height, glucose lev-

els and activity levels.12

The issues relating to pa-

tients education and compliance as well as the

cost of insulin should be considered. These ar-

guments place oral hypoglycemic therapy intofavors for women with GDM,.13 However, it isimportant to take into account fetomaternal im-

pact of oral hypoglycemic agentsfor the womenwith GDM. Metformin, which is used for T2D, is

a foremost choice. Metformin has been found tohave a transplacental transfer rate of 1016%14,15this raises possible concerns about risks of fetal

anomalies, and undesirable effects for mothersand the newborns after delivery limiting its role

The safety and use of Metformin in pregnan-cy is under consideration. But the inferencesdrawn from variety of trials, which are underpow-

ered,16,17,18,19 lack the ability to dene the relativerisks and benets ofmetformin for GDM.

The rationale of this study was to compare theefcacy of metformin with insulin in terms of feto-maternal outcome in gestational diabetes melli-

tus. There is variability in the literature that is pub-lished internationally. The study results may ormay not differ from international data due to poor

compliance and genetic variation from patient topatient, in the light of which new suggestions will

be made for the liberal use of metformin in popu-

lation and to minimize the use of parenteral ther-apy (insulin).

OBJECTIVE

To compare the outcome of Metformin with insulin

in gestational diabetes mellitus.

PATIENTS AND METHODS

This randomized controlled trial study was carriedout on 500 pregnant women with GDM admitted

in the antenatal ward of Lady Aitchison Hospitalfrom Jan 2014 to March 2015. Written informed

consent was obtained. The women were included

in the study through non-probability, consecutivesampling.

Demographic information on all variables includ-ed; patients age, gestational age, body mass in-dex and maternal weight gain during pregnancy

were noted. The patients were divided in to twoequal groups (A & B) by randomization. Patientsin the group A were given tablet metformin 500mg

by oral route and group B was administrated in-jection regular insulin by subcutaneous route.Maternal BSL (2 levels i.e. BSF, 1 hour post pran-

dial) were done hospital laboratory until deliveryand dose of metformin and insulin was adjusted

according to BSL. Fetal monitoring was done byultrasound in the third trimester for fetal weightevaluation. The women between 20-45 years of

age and GDM, gestational more than 20 weekswere included in the study and women who wereknown diabetic, with history of recent myocardi-

al infarction and twin pregnancy were excludedfrom the study.

The women were evaluated for outcome measureswhich were Preterm delivery (It will be consideredif birth is at


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RESULTSWe conducted this trial with 500 females includ-ed in the study with the mean age of 32.146.13

years. The mean gestational age was 31.073.8weeks 24-38weeks). There were 78 (15.6%) fe-males who had 0 parity, 107 (21.4%) females had

parity 1, 175 (35%) females had parity 2, 95 (19%)females had parity 3, 33 (6.6%) females had pari-

ty 4 and 12 (2.4%) females had parity 5.

The mean weight of females before treatment

was 70.1810.96 kg, which was increased to73.1411.49 kg after treatment. The overall meanchange in weight of females was 2.961.90kg.

There were 114 (22.8%) females had normal BMI,213 (42.6%) were overweight and 173 (34.6%)

were obese.

With metformin, the mean weight of females be-fore treatment was 69.6210.93kg, which was

increased to 72.0511.73 kg after treatment,with the mean weight change of 2.441.81kg. With insulin, the mean weight of females

was 70.7510.98kg, which was increased to74.2411.16 kg, with the mean weight change of

3.491.84 kg. Thus after treatment the differencewas signicant (P


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Study groupTotal

Metformin Insulin

Neonatalhypoglycemia

Yes23

(9.2%)64

(25.6%)87

(17%)

No227

(90.8%)186

(74.4%)413

(83%)

Total250

(100%)250

(100%)500

(100%)

Table-III. (Comparison of neonatal hypoglycemia)

DISCUSSIONIn this trial we observed that the mean age of32.146.13 years. The mean gestational age

was 31.073.8 weeks 24-38weeks). There were78 (15.6%) females who had 0 parity, 107 (21.4%)

females had parity 1, 175 (35%) females had par-

ity 2, 95 (19%) females had parity 3, 33 (6.6%)females had parity 4 and 12 (2.4%) females had

parity 5.

The mean weight of females before treatment

was 70.1810.96 kg, which was increased to73.1411.49 kg after treatment. The overall meanchange in weight of females was 2.961.90kg.

There were 114 (22.8%) females had normal BMI,213 (42.6%) were overweight and 173 (34.6%)

were obese.

With metformin, the mean weight of females be-fore treatment was 69.6210.93kg, which was

increased to 72.0511.73 kg after treatment,with the mean weight change of 2.441.81

kg. With insulin, the mean weight of femaleswas 70.7510.98kg which was increased to74.2411.16 kg, with the mean weight change

of 3.491.84 kg. Thus after treatment the differ-

ence was signicant (P


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obtained as signicant (P


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Ebeling T, et al. (2011)Metformin should be consid-ered in the treatment of gestational diabetes: apro-spective randomised study.BJOG 118: 880885.

14. Nanovskaya TN, Nekhayeva IA, Patrikeeva SL, HankinsGD, Ahmed MS(2006) Transfer of metformin acrossthe dually perfused human placental lobule.Am J Ob-stet Gynecol 195: 10811085.

15. Kovo M, Haroutiunian S, Feldman N, Hoffman A, Glezer-man M (2008)Determination of metformin transferacross the human placenta using a duallyperfusedex vivo placental cotyledon model.Eur J Obstet Gy-necol Reprod Biol136: 2933.

16. Tertti K, Ekblad U, Vahlberg T, Ronnemaa T (2008) Com-parison of metforminand insulin in the treatment ofgestational diabetes: a retrospective, case-controls-tudy.Rev Diabet Stud 5: 95101.

17. Balani J, Hyer SL, Rodin DA, Shehata H (2009) Preg-

nancy outcomes in womenwith gestational diabetestreated with metformin or insulin: a case-controlstudy.Diabet Med 26: 798802.

18. Goh JE, Sadler L, Rowan J (2011) Metformin for gesta-tional diabetes in routineclinical practice.Diabet Med

28: 10821087.

19. Rai L, Meenakshi D, Kamath A (2009) Metformina con-venient alternative toinsulin for Indian women withdiabetes in pregnancy.Indian J Med Sci 63: 491497.

20. Rowan JA, Hague WM, Gao W, Battin MR, Moore MP.

Metformin versus Insulin for the treatment of gesta-tional diabetes.N Engl J Med.2008;358(19):2003-15.

21. Balsells M, Garca-Patterson A, Sol I, Roqu M, Gich I,Corcoy R. Glibenclamide, metformin, and insulin forthe treatment of gestational diabetes: a systematicreview and meta-analysis.BMJ. 2015;350:h102.

22. Hughes R, Rowan J. Pregnancy in women with Type 2diabetes: who takes metformin and what is the out-come? Diabetic medicine.2006;23(3):318-22.

23. Niromanesh S, Alavi A, Sharbaf F, Amjadi N, Moosa-vi S, Akbari S. Metformin compared with insulin inthe management of gestational diabetes mellitus:A randomized clinical trial. Diabetes Res clin Pract2012;98:422-429.

24. Mesdaghinia E, Samimi M, Homaei Z, Saberi F, Moosa-vi S, Yaribakht M. Comparison of newborn outcomesin women with gestational diabetes mellitus treated

with metformin of insulin: A randomized blinded tri-al.Int J Prev Med 2013;4:327-333.

25. Spaulonci C, Bernardes L, Trindade T, Zugaib M, Fran-cisco R. Randomized trial of metformin vs insulin inthe management of gestational diabetes.Am J Obst

Gynecol 2013;208: Mar 21. pii: S0002- 9378(13)00296-2. doi: 10.1016/j.ajog.2013.03.022. [Epub ahead of print

26. G Juan, L Qing, F Ling. Metformin vs Insulin in man-agement of gestational diabetese: a meta anal-ysis.PLoS ONE 8(5): e64585. doi:10.1371/journal.pone.0064585

AUTHORSHIP AND CONTRIBUTION DECLARATION

Sr. # Author-s Full Name Contribution to the paper Author=s Signature

1

2

3

4

5

6

7

8

Tayyaba Majeed

Rabia Adnan

Irum Majeed

Hamis Mahmood

Kanwal Saba

Sardar Fakhar Imam

Muhammad Al-Fareed Zafar

Mulazim Hussain Bukhari

Principal researcher and

collection of data

Designed the researchProtocol

Helped in designing the

research protocolGive the computer help

Did the statistical analysis

Helped is weiting andnalizing the manuscriptHelped is weiting andnalizing the manuscriptSupervised the research


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C o p y r i g h t o f P r o f e s s i o n a l M e d i c a l J o u r n a l i s t h e p r o p e r t y o f P r o f e s s i o n a l M e d i c a l J o u r n a l a n d

i t s c o n t e n t m a y n o t b e c o p i e d o r e m a i l e d t o m u l t i p l e s i t e s o r p o s t e d t o a l i s t s e r v w i t h o u t t h e

c o p y r i g h t h o l d e r ' s e x p r e s s w r i t t e n p e r m i s s i o n . H o w e v e r , u s e r s m a y p r i n t , d o w n l o a d , o r e m a i l

a r t i c l e s f o r i n d i v i d u a l u s e .

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