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MFMU trial of treatment for mild gestational diabetes

A US randomized trial in women with mild gestational diabetes. Women were assigned to usual prenatal care or to diet advice, home blood sugar checks and insulin if needed. Treatment did not significantly reduce the main combined outcome for babies, but several other outcomes, such as large babies, caesarean births and high blood pressure disorders of pregnancy, were less common with treatment.

Also called MFMU mild GDM trial · Gestational Diabetes Mellitus Trial (GDM)

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group trial of treatment (dietary intervention, self-monitoring of blood glucose, and insulin therapy if necessary) against usual prenatal care in women with mild gestational diabetes, in the 24th to 31st week of gestation.
Phase
Not applicable
Enrolled
  • 7,381 participants (registry enrollment, type ACTUAL; the registry gives no unit) (enrolled count) (Gestational Diabetes Mellitus Trial (GDM), retrieved )
  • 958 women (randomized count) (A multicenter, randomized trial of treatment for mild gestational diabetes, retrieved )
  • 485 women assigned to treatment (randomized count) (A multicenter, randomized trial of treatment for mild gestational diabetes, retrieved )
  • 473 women assigned to the control group (randomized count) (A multicenter, randomized trial of treatment for mild gestational diabetes, retrieved )
Sponsor
Not recorded
Registry
  • NCT NCT00069576
Started
(Gestational Diabetes Mellitus Trial (GDM), retrieved )
Primary completion
(actual) (Gestational Diabetes Mellitus Trial (GDM), retrieved )
Completion
(actual) (Gestational Diabetes Mellitus Trial (GDM), retrieved )
Results first posted
(actual) (Gestational Diabetes Mellitus Trial (GDM), retrieved )
Countries
United States (Gestational Diabetes Mellitus Trial (GDM), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Randomized, parallel trial; the registry lists no masking. Registered as NCT00069576 (phase not applicable); lead sponsor The George Washington University Biostatistics Center (no organization record in this atlas, so no sponsor link is written), collaborator NICHD. The funded_by link to NICHD rests on the grants that the paper's PubMed record lists, not on the registry collaborator line. The abstract reports 958 women randomly assigned (485 treatment, 473 control); the registry reports an actual enrollment of 7381. The two counts are different, the registry gives no unit, and the atlas does not reconcile them. Results are recorded as separate claims on this page; the primary result (P=0.14) was not significant. The registry also lists a follow-up of children at 5 to 10 years as a primary outcome; it is not recorded here.

Arms

  • Treatment

    Intervention Treatment of gestational diabetes (diet, glucose monitoring, insulin or metformin)

    Dietary intervention, self-monitoring of blood glucose, and insulin therapy if necessary. The registry labels the arm Nutritional counseling and self blood glucose monitoring.

  • Control (usual prenatal care)

    Intervention None named

    Usual prenatal care. The registry labels the arm No treatment and says the group received written information on general nutrition for normal pregnancy.

Findings

No findings are published for this study.

Record details

Record id
maternal:mfmu-mild-gdm-trial
Content hash
2b7b23d963e9fbae89b15fa2350041417052c2e66158c90095f657526160a672