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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2018

Open Access 01-12-2018 | Research article

The treatment of booking gestational diabetes mellitus (TOBOGM) pilot randomised controlled trial

Authors: David Simmons, Jodie Nema, Chloe Parton, Lisa Vizza, Annette Robertson, Rohit Rajagopal, Jane Ussher, Janette Perz

Published in: BMC Pregnancy and Childbirth | Issue 1/2018

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Abstract

Background

We piloted a randomised controlled trial (RCT) comparing pregnancy outcomes among women with booking gestational diabetes (GDM) receiving immediate or deferred treatment.

Methods

Consecutive, consenting women < 20 weeks gestation, with GDM risk factors attending the hospital book-in clinic, completed an oral glucose tolerance test (OGTT). Clinicians were blinded to OGTT results. Women fulfilling World Health Organisation GDM criteria were randomised to either clinic referral /ongoing treatment (Treated Group n = 11), or no treatment (No Treatment Group n = 10). Women without ‘Booking GDM’ (‘Decoys’ n = 58) and those in the No Treatment Group had a repeat OGTT at 24–28 weeks (with GDM treated if diagnosed). Midwives and mothers were asked to complete surveys and attend focus groups before and after the study respectively regarding their experiences and expectations of the study protocol.

Results

Sufficient women completed each step of the RCT. Gestation at OGTT was late at 18 ± 2 weeks with Treated and No Treatment groups largely similar. At 24–28 weeks gestation, GDM was present in 8/9 (89%) in the No Treatment group and 11/56 (20%) Decoys. NICU admission was highest in the Treated group (36% vs 0% p = 0.043), largely due to small for gestational age, and Large for Gestational Age babies greatest in the No Treatment group (0% vs 33% p = 0.030).

Conclusion

An RCT deferring ‘Booking GDM’ treatment is feasible. Most women with untreated ‘Booking GDM’ in mid 2nd trimester had GDM at 24–28 weeks. Early treatment may have both benefits and harms. A full RCT is needed.

Trial registration

Australia New Zealand Clinical Trials Registry ACTRN12615000974505. Registered 17th May 2015; URL: https://​www.​anzctr.​org.​au/​Trial/​Registration/​TrialReview.​aspx?​id=​369100&​isReview=​true Retrospectively Registered.
Appendix
Available only for authorised users
Literature
1.
Metzger BE, Coustan DR. Summary and recommendations of the fourth international workshop conference on gestational diabetes mellitus. Diabetes Care. 1998;21(Suppl 2):B161–7.PubMed
2.
Cheung NW, Byth K. The population health significance of gestational diabetes. Diabetes Care. 2003;26(7):2005–9.CrossRefPubMed
3.
4.
Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS. Effect of treatment of gestational diabetes on pregnancy outcomes. New England J Med. 2005;352(24):2477–86.CrossRef
5.
Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A. A multicenter, randomized trial of treatment for mild gestational diabetes. New England J Med. 2009;361(14):1339–48.CrossRef
6.
IADPSG Consensus Panel. International Association of Diabetes and Pregnancy Study Groups (IADPSG) recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010;33(3):676–82.CrossRef
7.
8.
Zhu WW, Yang HX, Wei YM, Yan J, Wang ZL, Li XL, Wu HR, Li N, Zhang MH, Liu XH, Zhang H. Evaluation of the value of fasting plasma glucose in the first prenatal visit to diagnose gestational diabetes mellitus in China. Diabetes Care. 2013;36(3):586–90.CrossRefPubMedPubMedCentral
9.
McIntyre HD, Sacks DA, Barbour LA, Feig DS, Catalano PM, Damm P, McElduff A. Issues with the diagnosis and classification of hyperglycemia in early pregnancy. Diabetes Care. 2016;39(1):53–4.CrossRefPubMed
10.
11.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101.CrossRef
12.
Simmons D, Devlieger R, van Assche A, Jans G, Galjaard S, Corcoy R, Adelantado JM, Dunne F, Desoye G, Harreiter J, Kautzky-Willer A, Damm P, Mathiesen ER, Jensen DM, Andersen L, Lapolla A, Dalfrà MG, Bertolotto A, Wender-Ozegowska E, Zawiejska A, Hill D, Snoek FJ, Jelsma JG, van Poppel MN. Effect of physical activity and/or healthy eating on GDM risk: the DALI lifestyle study. J Clin Endocrinol Metab 2016, Dec 9 :jc20163455. [Epub ahead of print].
13.
Kingman A, Zion G. Some power considerations when deciding to use transformations. Stat Med. 1994;13:769–83.CrossRefPubMed
14.
The HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. New England J Med. 2008;358:1991–2002.CrossRef
15.
Langer O, Levy J, Brustman L, Anyaegbunam A, Merkatz R, Divon M. Glycemic control in gestational diabetes mellitus: how tight is tight enough; small for gestational age versus large for gestational age? Am J Obstet Gynecol. 1989;161(3):646–53.CrossRefPubMed
16.
Catalano PM, Mele L, Landon MB, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM, Saade G. Inadequate weight gain in overweight and obese pregnant women: what is the effect on fetal growth? Am J Obstet Gynaecol. 2014;211(2):137.e1–7.CrossRef
17.
Hales CN, Barker DJ. Type 2 (non-insulin-dependent) diabetes mellitus: the thrifty phenotype hypothesis. Diabetologia. 1992;35(7):595–601.CrossRefPubMed
18.
19.
Sweeting AN, Ross GP, Hyett J, Molyneaux L, Constantino M, Harding AJ, Wong J. Gestational diabetes mellitus in early pregnancy: evidence for poor pregnancy outcomes despite treatment. Diabetes Care. 2016;39(1):75–81.CrossRefPubMed
Metadata
Title
The treatment of booking gestational diabetes mellitus (TOBOGM) pilot randomised controlled trial
Authors
David Simmons
Jodie Nema
Chloe Parton
Lisa Vizza
Annette Robertson
Rohit Rajagopal
Jane Ussher
Janette Perz
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2018
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-018-1809-y

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