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Screening and subsequent management for gestational diabetes for improving maternal and infant health

  1. Joanna Tieu1,*,
  2. Andrew J McPhee2,
  3. Caroline A Crowther1,3,
  4. Philippa Middleton4

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 11 FEB 2014

Assessed as up-to-date: 1 DEC 2013

DOI: 10.1002/14651858.CD007222.pub3


How to Cite

Tieu J, McPhee AJ, Crowther CA, Middleton P. Screening and subsequent management for gestational diabetes for improving maternal and infant health. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD007222. DOI: 10.1002/14651858.CD007222.pub3.

Author Information

  1. 1

    The University of Adelaide, ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia

  2. 2

    Women's and Children's Hospital, Neonatal Medicine, North Adelaide, South Australia, Australia

  3. 3

    The University of Auckland, Liggins Institute, Auckland, New Zealand

  4. 4

    The University of Adelaide, Women's and Children's Research Institute, Adelaide, South Australia, Australia

*Joanna Tieu, ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, 1st floor, Queen Victoria Building, 72 King William Road, Adelaide, South Australia, 5006, Australia. joanna.tieu@gmail.com. joanna.tieu@mh.org.au.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 11 FEB 2014

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Characteristics of included studies [ordered by study ID]
Bergus 1992

MethodsRandomised controlled trial.

Funding: unspecified.


ParticipantsLocation: Ketchikan Native Health Clinic, Ketchikan, Alaska and Mt. Edgecumbe Hospital, Sitka, Alaska.

Inclusion criteria: pregnant native Alaskan women at 24-28 weeks' gestation, with no history of diabetes mellitus, between January 1988 and May 1990.

Exclusion criteria: none specified.

76 women were enrolled into the study.


InterventionsParticipants received either a 50 g glucose monomer or 50 g glucose polymer according to their randomly allocated group, regardless of time of last meal.

Both groups: venous and capillary samples were collected after 1 hour. A result of greater than or equal to 7.8 mmol/L was considered positive. All participants underwent a 100 g 3-hour OGTT within 3 days of their glucose challenge test.


OutcomesMaternal: venous plasma glucose following glucose challenge test, capillary blood glucose following glucose challenge test, OGTT and symptom questionnaire ('felt sick', 'felt nauseated', 'headache', 'felt dizzy', 'felt bloated', 'felt tired', 'vomited' and 'felt abdominal discomfort').

Infant: none.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'Randomisation was achieved by using consecutive numbers from a random number table.'

Allocation concealment (selection bias)Unclear riskNot specified.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk'Double-blind' implies that participants and personnel were blinded to randomised group, although this is not stated.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding of outcome assessors was not reported.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk'10 women did not complete the symptom questionnaire, but their baseline characteristics did not differ significantly from those with complete data collection.' These women (13%) were excluded from the analysis of symptoms.

Selective reporting (reporting bias)Low riskAll pre-specified outcomes were reported.

Other biasUnclear riskBaseline characteristics were not reported. It is therefore, unclear whether baseline imbalances exist.

Griffin 2000

MethodsQuasi-randomised controlled trial.

Funding: grant from Bayer Diagnostics and research grant from National Maternity Hospital, Dublin.


ParticipantsLocation: outpatient obstetric clinics at the National Maternity Hospital, Dublin.

Inclusion criteria: first visit to outpatient clinic of National Maternity Hospital, over a 24-month period.

Exclusion criteria: none specified.

3742 women were enrolled into the study, with 1853 randomised to the risk factor screening group and 1889 randomised to the universal screening group.


InterventionsRisk factor group: 100 g 3-hour OGTT performed at 32 weeks' gestation if any risk factors are present (historical - first-degree relative with diabetes mellitus, > 100 kg in current pregnancy, previous baby > 4.5 kg, previous unexplained stillbirth/intrauterine death, previous major malformation, previous GDM, current - glycosuria in 2nd fasting urine sample, macrosomia in current pregnancy or polyhydramnios in current pregnancy).

Universal group: 50 g 1-hour OGCT at 26-28 weeks' gestation without regard to time of last meal. This was considered positive if 1-hour plasma glucose was greater than or equal to 7.8 mmol/L. In those with a positive glucose challenge test, a 100 g OGTT was performed (using National Diabetes Data Group criteria). Women with risk factors for GDM (i.e. those listed for the risk factor group), had a repeat OGCT if the first OGCT was negative or if the OGTT was negative (following a positive OGCT).

Both groups: there was uniform diabetic and obstetric management for all participants, regardless of randomly allocated screening group. Women diagnosed with GDM were referred to both an obstetrician and endocrinologist, reviewed every 2 weeks until 36 weeks and awaited until 42 weeks unless medically contraindicated. All participants diagnosed with GDM were instructed in appropriate diabetic diet and intensive insulin treatment was instituted if fasting and postprandial (1.5 hour) blood glucose following a standard breakfast were not maintained (< 5.9 mmol/L or < 7.9 mmol/L respectively).


OutcomesMaternal: diagnosis of GDM, spontaneous vaginal birth at term, emergency caesarean section, pre-eclampsia and insulin treatment required.

Infant: LGA, macrosomia (> 4500 g), hypoglycaemia, hyperbilirubinaemia, gestational age at birth, ponderal index, admission to neonatal intensive care unit and preterm birth.


NotesWe are in correspondence with authors for additional data.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskThis trial was quasi-randomised. 'Randomisation to group was performed on the basis of which day the clinic was held as patients were randomly assigned clinics at booking.'

Allocation concealment (selection bias)High riskNot feasible since randomisation was based on the day women came to the clinic.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified. It was probably unfeasible for the study to blind participants and personnel.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding of outcome assessors was not reported.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk'There were no significant differences between those women who consented to glucose challenge test and those who refused with respect to weight, BMI, age, socio-economic group or presence of risk factors for GDM.' 590 (31%) women in the universal group were lost with no losses in the routine care group seen since routine care in this centre is the care received in the risk factor group.

Selective reporting (reporting bias)High riskOutcome data for participants were not available by original group allocation by day of visit, and were analysed by GDM diagnosis rather than randomly allocated group, affecting interpretation of outcome data.

Other biasHigh riskAs mentioned above, outcome data were analysed by GDM diagnosis rather than by original group allocation by day of visit.

Martinez Collado 2003

MethodsRandomised controlled trial.

Funding: not specified.


ParticipantsLocation: Hospital Regional 1o de Octubre.

Inclusion criteria: pregnant women at 24 to 28 weeks' gestation with a high-risk pregnancy.

Exclusion criteria: women with diabetes mellitus, previously diagnosed with GDM or on steroid or tocolytic therapy.

30 women were enrolled into the study, with 15 allocated to a 50 g glucose challenge test and 15 women allocated to receive a food mix.


InterventionsGlucose challenge test group: received a 50 g glucose solution orally.

Food group: received food mix containing carbohydrate, protein, fats and 50 g of glucose.

A venous blood sample was taken 1 hour after consuming the glucose solution or food mix. A glucose level greater than 140 mg/dL was considered abnormal.


OutcomesMaternal: positive screen for GDM and tolerance to food or solution.

Infant: none specified.


NotesStudy was reported in Spanish.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThe allocation of participants is described as being 'randomly assigned', no further information is provided on the sequence generation.

Allocation concealment (selection bias)Unclear riskNot specified.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified. It is likely that blinding of participants was unfeasible, and blinding of study personnel was not reported.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding of outcome assessors was not reported.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLosses to follow-up were not reported.

Selective reporting (reporting bias)Low riskThe pre-specified outcomes of outcome of venous blood sample and tolerance to food or solution were reported.

Other biasUnclear riskThere was no baseline comparison of participants in the 2 groups.

Murphy 1994

MethodsRandomised controlled trial.

Funding: not specified.


ParticipantsLocation: Saint Luke's Hospital, Kansas City, Missouri.

Inclusion criteria: pregnant women at the Medical Education Clinics, Saint Luke's Hospital, Kansas City, Missouri.

Exclusion criteria: none specified.

Of the 124 women who were enrolled into the study, 44 were allocated to group 1 (glucose polymer), 41 were allocated to group 2 (d-glucose) and 39 were allocated to group 3 (candy bar). 16 of the 124 women were unable to complete the glucose tolerance test within 1 week of screening, as required by all participants. Of these 16 women, 5 vomited or were too symptomatic and 11 did not complete the glucose tolerance test for logistical reasons or incomplete data.


InterventionsThose recruited, following hospital protocol, were screened at 24-28 weeks. Where the woman possessed 1 of the following risk factors, they also receive GDM screening at their initial visit (past history of glucose intolerance, first-degree relative with diabetes mellitus, age > 35 years, past macrosomia, habitual abortion, unexplained stillbirth, congenital anomalies or current pregnancy with glycosuria, hypertension, suspected LGA fetus, polyhydramnios or obesity). For each of the screening methods, the carbohydrate source was ingested without regard to time of last meal. Within 1 week of the screening test, all women were required to undergo a 100 g 3-hour glucose tolerance test (in 300 mL of carbonated water). GDM was diagnosed using O'Sullivan criteria.

Group 1 (n = 44): participants received 50 g of glucose polymer. This was made from 100 mL of 43% polymer solution with 1.5 g unsweetened flavouring and 50 mL of unsweetened club soda.

Group 2 (n = 41): participants received the standard 50 g d-glucose solution in 300 mL of carbonated water.

Group 3 (n = 39): participants received a total of 50 g of candy bar (containing milk chocolate, sucrose, corn syrup, partially hydrogenated soya bean oil, cocoa, salt, egg whites, malt extract, soybean protein and artificial flavour).


OutcomesMaternal: diagnosis of GDM, serum glucose values following screening and symptom questionnaire (taste, abdominal pain, bloating, dizziness and nausea).

Infant: none reported.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot specified. Women were 'prospectively enrolled and randomly assigned to receive 1 of 3 different carbohydrate sources for their GDM screening'.

Allocation concealment (selection bias)Unclear riskNot specified.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified for participants, clinicians and outcome assessors.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot specified for participants, clinicians and outcome assessors.

Incomplete outcome data (attrition bias)
All outcomes
High riskData from 16 of the 124 women (13%) were not included in the final analysis as they were unable to complete the glucose tolerance test within 1 week. Of these women, 5 were unable to complete because they became symptomatic during the test and the remaining 11 were unable to complete the test for logistical reasons or because there was incomplete laboratory data. The number of women lost to follow-up from each treatment group is not reported. A comparison of baseline characteristics was not made on those lost to follow-up and those not.

Furthermore, it is not reported how many of the women included in the study were screened in their first trimester or at the standard 24 to 28 weeks' gestation.

Selective reporting (reporting bias)High riskSide effects were only reported where the women rated it in the moderate to severe range (3 to 5 out of a possible 5). Therefore, mild symptoms were not reported.

Other biasLow riskNo obvious source of other bias.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Berkus 1995Study assessed strategies for diagnosis of GDM, not screening.

Brustman 1995Study assessed strategies for diagnosis of GDM, not screening.

Buhling 2004Study assessed strategies for diagnosis of GDM, not screening.

Cheng 1992Study assessed strategies for diagnosis of GDM, not screening.

Court 1984Study assessed strategies for diagnosis of GDM, not screening.

Court 1985Study assessed strategies for diagnosis of GDM, not screening.

Dornhorst 2000Not a randomised controlled trial.

Duenas-Garcia 2011Study assessed strategies for diagnosis of GDM, not screening.

Eslamian 2007Cross-over study.

Eslamian 2008Cross-over study.

Fung 1993Study assessed strategies for diagnosis of GDM, not screening.

Harlass 1991Study assessed strategies for diagnosis of GDM, not screening.

Helton 1989Cross-over study.

Hidar 2001Cross-over study.

Jones 1993Study assessed strategies for diagnosis of GDM, not screening.

Kjos 2001Women in this study had already been diagnosed with GDM.

Lamar 1999aCross-over study.

Lamar 1999bCross-over study.

Lewis 1993Women in this study had already been diagnosed with GDM or had undergone a process for diagnosis of GDM.

Meltzer 2010Study assessed strategies for diagnosis of GDM, not screening.

Olarinoye 2004Study assessed strategies for diagnosis of GDM, not screening.

Saijan 2011Study assessed strategies for diagnosis of GDM, not screening. Unclear if this study was randomised.

Sammarco 1993Study assessed strategies for diagnosis of GDM, not screening.

Soonthornpun 2003Study assessed strategies for diagnosis of GDM, not screening.

Soonthornpun 2008Cross-over study.

Stavrianos 2004Study assessed strategies for diagnosis of GDM, not screening.

Weiss 1998Study assessed strategies for diagnosis of GDM, not screening.

Zhang 1995Study assessed strategies for diagnosis of GDM, not screening.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Bebbington 1999

MethodsType of study: randomised controlled trial.

Method of randomisation: unspecified.

Loss of participants to follow-up: 18 of 2401 women were lost to follow-up.

Intention-to-treat analysis: unspecified.

Blinding: unfeasible to blind participants or healthcare providers. 'Blinded assessors collected outcomes postpartum.'

Funding: unspecified.

ParticipantsLocation: British Columbia Women's Hospital, British Columbia, Canada.

Inclusion criteria: low-risk pregnancy at British Columbia Women's Hospital.

Exclusion criteria: risk factors for GDM (specific risk factors not specified).

2401 women were enrolled into the study. 1197 women were allocated to the routine screening arm and 1204 women were allocated to the selected screening arm.

InterventionsRoutine testing group: received a 50 g glucose screen and a full 100 g glucose tolerance test was performed in women whose 1 hour glucose was > 7.8 mmol/L on 50 g screening.

Selected screening group: received glucose testing only for selected indications that arose during pregnancy.

OutcomesMaternal: none.

Infant: birthweight and macrosomia.

NotesThe only publication of this trial is a conference abstract. We are in correspondence with the authors for additional data. No contact as at July 2013.

 
Comparison 1. Risk factor versus universal screening

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Diagnosis of gestational diabetes13152Risk Ratio (M-H, Fixed, 95% CI)0.44 [0.26, 0.75]

 2 Gestational age at birth13152Mean Difference (IV, Fixed, 95% CI)-0.15 [-0.27, -0.03]

 
Comparison 2. Glucose monomer versus glucose polymer

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Diagnosis of gestational diabetes2161Risk Ratio (M-H, Fixed, 95% CI)1.61 [0.28, 9.15]

 2 Positive screen for gestational diabetes185Risk Ratio (M-H, Fixed, 95% CI)2.36 [0.90, 6.21]

 3 Symptoms2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    3.1 Any symptom
2151Risk Ratio (M-H, Random, 95% CI)2.80 [1.10, 7.13]

    3.2 Headache
166Risk Ratio (M-H, Random, 95% CI)5.0 [0.62, 40.51]

    3.3 Dizziness
2151Risk Ratio (M-H, Random, 95% CI)2.50 [0.93, 6.76]

    3.4 Nausea
2151Risk Ratio (M-H, Random, 95% CI)2.62 [1.01, 6.79]

    3.5 Abdominal discomfort
2151Risk Ratio (M-H, Random, 95% CI)6.15 [0.76, 50.08]

    3.6 Vomiting
166Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    3.7 Sick
166Risk Ratio (M-H, Random, 95% CI)9.00 [0.50, 160.78]

    3.8 Tired
166Risk Ratio (M-H, Random, 95% CI)0.75 [0.18, 3.09]

    3.9 Bloating
185Risk Ratio (M-H, Random, 95% CI)11.79 [0.67, 206.69]

 4 Taste185Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.34, 2.04]

 
Comparison 3. Glucose monomer versus candy bar

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Diagnosis of gestational diabetes180Risk Ratio (M-H, Fixed, 95% CI)6.67 [0.36, 125.02]

 2 Positive screen for gestational diabetes180Risk Ratio (M-H, Fixed, 95% CI)3.49 [1.05, 11.57]

 3 Taste180Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.17, 0.74]

 4 Symptoms1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Any symptom
180Risk Ratio (M-H, Fixed, 95% CI)1.90 [0.97, 3.72]

    4.2 Dizziness
180Risk Ratio (M-H, Fixed, 95% CI)1.66 [0.53, 5.24]

    4.3 Nausea
180Risk Ratio (M-H, Fixed, 95% CI)0.71 [0.17, 2.99]

    4.4 Abdominal discomfort
180Risk Ratio (M-H, Fixed, 95% CI)6.67 [0.36, 125.02]

    4.5 Bloating
180Risk Ratio (M-H, Fixed, 95% CI)1.19 [0.34, 4.11]

 
Comparison 4. Glucose polymer versus candy bar

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Diagnosis of gestational diabetes183Risk Ratio (M-H, Fixed, 95% CI)4.44 [0.22, 89.84]

 2 Positive screen for gestational diabetes183Risk Ratio (M-H, Fixed, 95% CI)1.48 [0.38, 5.78]

 3 Taste183Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.22, 0.82]

 4 Symptoms1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Any symptom
183Risk Ratio (M-H, Fixed, 95% CI)0.39 [0.13, 1.18]

    4.2 Dizziness
183Risk Ratio (M-H, Fixed, 95% CI)0.66 [0.16, 2.79]

    4.3 Nausea
183Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.06, 13.70]

    4.4 Abdominal discomfort
183Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.5 Bloating
183Risk Ratio (M-H, Fixed, 95% CI)0.10 [0.01, 1.78]

 
Comparison 5. Glucose versus food

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Positive screen for gestational diabetes130Risk Ratio (M-H, Fixed, 95% CI)7.0 [0.39, 124.83]

 2 Any symptom130Risk Ratio (M-H, Fixed, 95% CI)12.0 [1.78, 81.06]