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Meta-Analysis
. 2017 Jan 25;1(1):CD011967.
doi: 10.1002/14651858.CD011967.pub2.

Oral anti-diabetic pharmacological therapies for the treatment of women with gestational diabetes

Julie Brown  1 , Ruth Martis  1 , Brenda Hughes  2 , Janet Rowan  3 , Caroline A Crowther  1   4
Affiliations
Meta-Analysis

Oral anti-diabetic pharmacological therapies for the treatment of women with gestational diabetes

Julie Brown et al. Cochrane Database Syst Rev. .

Abstract

Background: Gestational diabetes mellitus (GDM) is a major public health issue with rates increasing globally. Gestational diabetes, glucose intolerance first recognised during pregnancy, usually resolves after birth and is associated with short- and long-term complications for the mother and her infant. Treatment options can include oral anti-diabetic pharmacological therapies.

Objectives: To evaluate the effects of oral anti-diabetic pharmacological therapies for treating women with GDM.

Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register (14 May 2016), ClinicalTrials.gov, WHO ICTRP (14 May 2016) and reference lists of retrieved studies.

Selection criteria: We included published and unpublished randomised controlled trials assessing the effects of oral anti-diabetic pharmacological therapies for treating pregnant women with GDM. We included studies comparing oral anti-diabetic pharmacological therapies with 1) placebo/standard care, 2) another oral anti-diabetic pharmacological therapy, 3) combined oral anti-diabetic pharmacological therapies. Trials using insulin as the comparator were excluded as they are the subject of a separate Cochrane systematic review.Women with pre-existing type 1 or type 2 diabetes were excluded.

Data collection and analysis: Two review authors independently assessed trials for inclusion and trial quality. Two review authors independently extracted data and data were checked for accuracy.

Main results: We included 11 studies (19 publications) (1487 women and their babies). Eight studies had data that could be included in meta-analyses. Studies were conducted in Brazil, India, Israel, UK, South Africa and USA. The studies varied in diagnostic criteria and treatment targets for glycaemic control for GDM. The overall risk of bias was 'unclear' due to inadequate reporting of methodology. Using GRADE the quality of the evidence ranged from moderate to very low quality. Evidence was downgraded for risk of bias (reporting bias, lack of blinding), inconsistency, indirectness, imprecision and for oral anti-diabetic therapy versus placebo for generalisability. Oral anti-diabetic pharmacological therapies versus placebo/standard careThere was no evidence of a difference between glibenclamide and placebo groups for hypertensive disorders of pregnancy (risk ratio (RR) 1.24, 95% confidence interval (CI) 0.81 to 1.90; one study, 375 women, very low-quality evidence), birth by caesarean section (RR 1.03, 95% CI 0.79 to 1.34; one study, 375 women, very low-quality evidence), perineal trauma (RR 0.98, 95% CI 0.06 to 15.62; one study, 375 women, very low-quality evidence) or induction of labour (RR 1.18, 95% CI 0.79 to 1.76; one study, 375 women; very low-quality evidence). No data were reported for development of type 2 diabetes or other pre-specified GRADE maternal outcomes (return to pre-pregnancy weight, postnatal depression). For the infant, there was no evidence of a difference in the risk of being born large-for-gestational age (LGA) between infants whose mothers had been treated with glibenclamide and those in the placebo group (RR 0.89, 95% CI 0.51 to 1.58; one study, 375, low-quality evidence). No data were reported for other infant primary or GRADE outcomes (perinatal mortality, death or serious morbidity composite, neurosensory disability in later childhood, neonatal hypoglycaemia, adiposity, diabetes). Metformin versus glibenclamideThere was no evidence of a difference between metformin- and glibenclamide-treated groups for the risk of hypertensive disorders of pregnancy (RR 0.70, 95% CI 0.38 to 1.30; three studies, 508 women, moderate-quality evidence), birth by caesarean section (average RR 1.20, 95% CI 1.20; 95% CI 0.83 to 1.72, four studies, 554 women, I2 = 61%, Tau2 = 0.07 low-quality evidence), induction of labour (0.81, 95% CI 0.61 to 1.07; one study, 159 women; low-quality evidence) or perineal trauma (RR 1.67, 95% CI 0.22 to 12.52; two studies, 158 women; low-quality evidence). No data were reported for development of type 2 diabetes or other pre-specified GRADE maternal outcomes (return to pre-pregnancy weight, postnatal depression). For the infant there was no evidence of a difference between the metformin- and glibenclamide-exposed groups for the risk of being born LGA (average RR 0.67, 95% CI 0.24 to 1.83; two studies, 246 infants, I2 = 54%, Tau2 = 0.30 low-quality evidence). Metformin was associated with a decrease in a death or serious morbidity composite (RR 0.54, 95% CI 0.31 to 0.94; one study, 159 infants, low-quality evidence). There was no clear difference between groups for neonatal hypoglycaemia (RR 0.86, 95% CI 0.42 to 1.77; four studies, 554 infants, low-quality evidence) or perinatal mortality (RR 0.92, 95% CI 0.06 to 14.55, two studies, 359 infants). No data were reported for neurosensory disability in later childhood or for adiposity or diabetes. Glibenclamide versus acarboseThere was no evidence of a difference between glibenclamide and acarbose from one study (43 women) for any of their maternal or infant primary outcomes (caesarean section, RR 0.95, 95% CI 0.53 to 1.70; low-quality evidence; perinatal mortality - no events; low-quality evidence; LGA , RR 2.38, 95% CI 0.54 to 10.46; low-quality evidence). There was no evidence of a difference between glibenclamide and acarbose for neonatal hypoglycaemia (RR 6.33, 95% CI 0.87 to 46.32; low-quality evidence). There were no data reported for other pre-specified GRADE or primary maternal outcomes (hypertensive disorders of pregnancy, development of type 2 diabetes, perineal trauma, return to pre-pregnancy weight, postnatal depression, induction of labour) or neonatal outcomes (death or serious morbidity composite, adiposity or diabetes).

Authors' conclusions: There were insufficient data comparing oral anti-diabetic pharmacological therapies with placebo/standard care (lifestyle advice) to inform clinical practice. There was insufficient high-quality evidence to be able to draw any meaningful conclusions as to the benefits of one oral anti-diabetic pharmacological therapy over another due to limited reporting of data for the primary and secondary outcomes in this review. Short- and long-term clinical outcomes for this review were inadequately reported or not reported. Current choice of oral anti-diabetic pharmacological therapy appears to be based on clinical preference, availability and national clinical practice guidelines.The benefits and potential harms of one oral anti-diabetic pharmacological therapy compared with another, or compared with placebo/standard care remains unclear and requires further research. Future trials should attempt to report on the core outcomes suggested in this review, in particular long-term outcomes for the woman and the infant that have been poorly reported to date, women's experiences and cost benefit.

PubMed Disclaimer

Conflict of interest statement

Julie Brown has received a NZD 15,000 internal University grant to assist with the preparation of a Cochrane overview of treatment for gestational diabetes. This is one of the reviews that has been supported. The funds have contributed to a research assistant's time. The funding body gains no financial interest from the publication of the review and has not influenced the content.

Ruth Martis: none known

Brenda Hughes: none known

Janet Rowan: none known

Caroline A Crowther: none known

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 1 Hypertensive disorders of pregnancy.
1.2
1.2. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 2 Caesarean section.
1.3
1.3. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 3 Large‐for‐gestational age.
1.4
1.4. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 4 Use of additional pharmacotherapy.
1.5
1.5. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 5 Glycaemic control (end of treatment) (mg/dL).
1.6
1.6. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 6 Weight gain in pregnancy (Kg).
1.7
1.7. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 7 Induction of labour.
1.8
1.8. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 8 Perineal trauma.
1.9
1.9. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 9 Stillbirth.
1.10
1.10. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 10 Neonatal death.
1.11
1.11. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 11 Small‐for‐gestational age.
1.12
1.12. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 12 Macrosomia.
1.13
1.13. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 13 Birthweight (g).
1.14
1.14. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 14 Shoulder dystocia.
1.15
1.15. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 15 Bone fracture.
1.16
1.16. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 16 Nerve palsy.
1.17
1.17. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 17 Gestational age at birth (weeks).
1.18
1.18. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 18 Neonatal hypoglycaemia.
1.19
1.19. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 19 Hyperbilirubinaemia.
1.20
1.20. Analysis
Comparison 1 Oral anti‐diabetic agents versus placebo, Outcome 20 Admission to NICU.
2.1
2.1. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 1 Hypertensive disorders of pregnancy.
2.2
2.2. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 2 Caesarean section.
2.3
2.3. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 3 Perinatal mortality.
2.4
2.4. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 4 Large‐for‐gestational age.
2.5
2.5. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 5 Death or serious morbidity composite.
2.6
2.6. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 6 Use of additional pharmacotherapy.
2.7
2.7. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 7 Maternal hypoglycaemia.
2.8
2.8. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 8 Glycaemic control (mg/L; mmol/L).
2.9
2.9. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 9 Weight gain in pregnancy (Kg).
2.10
2.10. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 10 Induction of labour.
2.11
2.11. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 11 Perineal trauma.
2.12
2.12. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 12 Stillbirth.
2.13
2.13. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 13 Macrosomia.
2.14
2.14. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 14 Birth trauma.
2.15
2.15. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 15 Shoulder dystocia.
2.16
2.16. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 16 Gestational age at birth (weeks).
2.17
2.17. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 17 Preterm birth.
2.18
2.18. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 18 5‐minute Apgar < 7.
2.19
2.19. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 19 Birthweight (g).
2.20
2.20. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 20 Ponderal index.
2.21
2.21. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 21 Neonatal hypoglycaemia.
2.22
2.22. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 22 Respiratory distress syndrome.
2.23
2.23. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 23 Hyperbilirubinaemia.
2.24
2.24. Analysis
Comparison 2 Metformin versus glibenclamide, Outcome 24 Admission to NICU.
3.1
3.1. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 1 Caesarean section.
3.2
3.2. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 2 Perinatal mortality.
3.3
3.3. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 3 Large‐for‐gestational age.
3.4
3.4. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 4 Need for additional pharmacotherapy.
3.5
3.5. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 5 Maternal hypoglycaemia.
3.6
3.6. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 6 Weight gain in pregnancy (Kg).
3.7
3.7. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 7 Macrosomia.
3.8
3.8. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 8 Small‐for‐gestational age.
3.9
3.9. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 9 Birth trauma (not specified).
3.10
3.10. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 10 Gestational age at birth (weeks).
3.11
3.11. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 11 Preterm birth.
3.12
3.12. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 12 Birthweight (Kg).
3.13
3.13. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 13 Neonatal hypoglycaemia.
3.14
3.14. Analysis
Comparison 3 Glibenclamide versus acarbose, Outcome 14 Respiratory distress syndrome.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD011967

References

References to studies included in this review

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Ainuddin 2013 {published data only}
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Berens 2015 {published data only}
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