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Diet Plus Insulin Compared to Diet Alone In The Treatment of GDM Mothers in HUSM , Kelantan.

Wan Faizah M, Nik Ahmad Zuky NL, Mohd Pazudin I, Che Anuar CYDepartment of Obstetric and Gynecology, School of Medical Science, USM, Kelantan. Malaysia

Objectives

Study Hypothesis

Women with gestational diabetes mellitus (GDM) treated with diet and insulin has better fetal and maternal outcomes as compared to patients treated with diet alone

General objective

To compare the pregnancy and neonatal outcome in the patients treated with diet plus insulin versus diet alone in the treatment of GDM in HUSM Specific objectives

1. To determine the proportion of GDM women treated with diet plus insulin and those managed with diet therapy alone. 2. To determine the maternal factors associated with the insulin requirement.

3. To compare the maternal (i.e. gestational hypertension without proteinuria, preeclampsia, polyhydramnios, caesarean delivery, post-partum hemorrhage) and neonatal (i.e. prematurity, fetal macrosomia, Apgar score < 7 at 5 minutes, fetal hypoglycemia, NICU admission) outcome of those treated with diet plus insulin versus those treated with diet alone in GDM mothers.

Methods

Methodology It was a prospective cohort study, conducted in Hospital Universiti Sains Malaysia (HUSM) from May 2010 till May 2011, involving 198 pregnant women diagnosed GDM who attended to Antenatal Clinic and admitted to antenatal ward HUSM and fulfilled the inclusion and exclusion criteria.

Approved by the Research and Ethical Committee, School of Medical Sciences, USM on February 2010.

Inclusion criteria

1.Pregnant mother diagnosed with GDM ( WHO criteria 1999)2. Singleton pregnancy

Exclusion criteria 1. Women with known pregestational diabetes.2. Women with Hypertensive disorder in pregnancy.3. Women with other preexisting medical illness such as chronic renal disease , SLE, Thyroid disease, epilepsy, blood disorder.4. Delivered in centre other than HUSM

Flow of Study

Results

1. Out of 198 participants, 29.8% ( n= 59 ) required insulin whille 70.2% ( n=139 ) of participants required diet only therapy to achieve normoglycemia

Table 1: Associations of maternal factors with insulin requirements in the treatment of GDM

3. Table 2: Incidence of maternal and fetal complications in GDM mothers treated with insulin plus diet therapy as compared to diet only

Conclusions

References

1. 29.8% of GDM women required insulin in order to achieve normoglycemia while 70.2% of study populations required diet only to achieve normoglycemia

2. There are statistically significant association between multiparity, maternal obesity, previous history of GDM , previous history of insulin injections , POG at diagnosis of GDM and HbA1c value at the study entry with the insulin requirements in the GDM mothers. Thus it is possible to predict requirements of insulin in the GDM mothers.

3. There is statistically significant reduction in the incidence of fetal macrosomia in the insulin plus diet group as compared to diet only group ( 10.2% vs 23.0% ).

4. Treatment with insulin plus diet were associated with slight reduction in the incidence gestational hypertension ( 6.8% vs 12.9%) , incidence of PE (3.4% vs 6.5%), incidence of polyhydramnios (8.5% vs 16.5%), incidence of PPH ( 1.7% vs 4.3% ), incidence of neonatal hypoglycemia ( 8.6% vs 17.3%) and incidence of poor Apgar score (1.7% vs 2.2%) compared to diet alone in patients with GDM.

5. The incidence of Caesarean deliveries was similar in both groups ( 30.5% vs 30.2%)

6. There were slight increased in the incidence of prematurity ( 6.8% vs 4.3%) and NICU admission ( 20.7% vs 18.7%) in

the diet plus insulin group compared to diet alone group.

7. It can be concluded that insulin is an effective drug as it is associated with reduction in the incidence of adverse fetal and maternal outcomes if compared to diet alone in the management of GDM mothers.

OPTIONALLOGO HERE

OPTIONALLOGO HERE

1. CFan, Z.T., Yang, H.X., Gao, X.L.(2006). Pregnancy outcomes in GDM. International Journal of Obstetric and Gynecology, 94, 12-16.

2. Graffida, F.M.A., Atallah, A.N.(2003).Diet plus insulin compared to diet alone in the treatment of GDM: A systemic review. Journal of medical & biological research,36, 1297-1300.

3. National Institute for Health and Clinical Excellence (NICE), Diabetes in Pregnancy, March 2008 ( revised reprint July 2008).

4. Gonzalez-Quintero,V.H., Istwan, N.B., Rhea, D.J.,De laTorre et al.(2008). Antenatal factors predicting subsequent need for insulin treatment in women with GDM.J Womens Health (Larchmt), 17(7),1183—1187.

Factors Insulin requirements { n (%) }

P value

1. Maternal age ( years)<2020 to 34≥35

1 ( 1.7) 35 (59.3) 23 (39.0)

0.476

2. ParityNulliparityPara 1 to 5Para 6 and above

11 ( 18.6 ) 41 ( 69.5 ) 7 ( 11.9 )

0.006

3. BMI at booking ( kg/m² )< 18.5018.50 to 24.9925.00 to 29.99≥ 30.00

- 8 ( 13.6 ) 32 ( 54.2) 19 ( 32.2)

0.004

4. Family history of DM Yes No

33 ( 55.9 ) 26 ( 44.1)

0.636

5. Previous history Of GDMYesNo

30 ( 50.8 ) 29 ( 49.2)

< 0.001

6. Prior history of insulin therapyYesNo

10 ( 16.9 ) 49 ( 83.1)

0.002

7. Prior history of macrosomic babyYesNo

12 ( 20.3 ) 47 ( 79.7 )

0.111

8. POG at diagnosis of GDM≤ 1415 to 28> 28

15 ( 25.4 ) 44 ( 74.6 )-

0.010

9. HbA1c level at study entry< 77 to 8>8

39 ( 66.1 ) 14 ( 23.7 ) 6 ( 10.3 )

< 0.001

Parameters Diet only group( n=139)

Insulin plus diet group (n= 59)

Total (n=198)

P value

Gestational hypertension

18 ( 12.9%) 4 (6.8%) 22 (11.1%) 0.206

Preeclampsia 9 (6.5%) 2 ( 3.4%) 11 ( 5.6%) 0.386

Polyhydramnios 23 (16.5%) 5 ( 8.5%) 28 (14.1%) 0.136

Premature labour

6 (4.3%) 4 ( 6.8%) 10 ( 5.1%) 0.469

Fetal macrosomia

32 (23.0%) 6 (10.2%) 38 (19.2%) 0.036

Caesarean section

42 (30.2%) 18 (30.5%) 60 (30.3%) 0.967

PPH 6 (4.3%) 1 ( 1.7%) 7 ( 3.5%) 0.361

Apgar score < 7 at 5 minutes

3 ( 2.2%) 1 ( 1.7%) 4 (2.0%) 0.844

Neonatal hypoglycemia

24 ( 17.3%) 5 ( 8.6%) 29 (14.7%) 0.119

NICU admission 26 ( 18.7%) 12 ( 20.7%) 38( 19.3%) 0.748

REFERENCE POPULATION All antenatal mothers with GDM and fulfilled criteria

. Referral to dietician for dietary advice2. Blood taken for HbA1c at study entry2. Diabetic diet therapy for 2 weeks3. Pre-prandial BSP were taken after 2 weekson dietary therapy.

DIET ONLY GROUPBSP measured 2 weekly. Uncontrolled BSP – 2 participants excluded from the study, 2 delivered elsewhere.BP monitoring and urine test for proteinuria

DIET PLUS INSULIN GROUPBSP measured 2 weeklyUncontrolled BSP- adjust insulin accordinglyBP monitoring and urine test for proteinuria

Normal BSP n=143 Abnormal BSP n =59

DELIVERY1.Data on delivery (139 participants from diet only group and 59 participants from diet plus insulin group) and maternal outcomes obtained from delivery records.2.Data on fetal outcomes obtained from delivery record.