# MFMU trial of treatment for mild gestational diabetes

Study · id `maternal:mfmu-mild-gdm-trial` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (public)

> General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here.

The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations.

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

Browse, life stage: Pregnancy; Newborn  
Browse, care area: Pregnancy conditions  

## In plain language

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.

## 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.

## Key facts

- 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: 7381 participants (registry enrollment, type ACTUAL; the registry gives no unit) (enrolled count; Gestational Diabetes Mellitus Trial (GDM), snapshot `maternal:ctgov-nct00069576-2026-10-14`, retrieved 2026-10-14); 958 women (randomized count; A multicenter, randomized trial of treatment for mild gestational diabetes, snapshot `maternal:pubmed-19797280-2026-10-14`, retrieved 2026-10-14); 485 women assigned to treatment (randomized count; A multicenter, randomized trial of treatment for mild gestational diabetes, snapshot `maternal:pubmed-19797280-2026-10-14`, retrieved 2026-10-14); 473 women assigned to the control group (randomized count; A multicenter, randomized trial of treatment for mild gestational diabetes, snapshot `maternal:pubmed-19797280-2026-10-14`, retrieved 2026-10-14)
- Started: 2002-10 (Gestational Diabetes Mellitus Trial (GDM), snapshot `maternal:ctgov-nct00069576-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2007-11 (actual) (Gestational Diabetes Mellitus Trial (GDM), snapshot `maternal:ctgov-nct00069576-2026-10-14`, retrieved 2026-10-14)
- Completion: 2013-10 (actual) (Gestational Diabetes Mellitus Trial (GDM), snapshot `maternal:ctgov-nct00069576-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2019-05-31 (actual) (Gestational Diabetes Mellitus Trial (GDM), snapshot `maternal:ctgov-nct00069576-2026-10-14`, retrieved 2026-10-14)
- Countries: United States (Gestational Diabetes Mellitus Trial (GDM), snapshot `maternal:ctgov-nct00069576-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `maternal:ctgov-nct00069576-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests treatment of mild gestational diabetes against usual prenatal care: Treatment of gestational diabetes (diet, glucose monitoring, insulin or metformin) (`maternal:gdm-treatment`)
- Registry condition: Diabetes, Gestational: Gestational diabetes (`maternal:gestational-diabetes`)
- The PubMed record lists NICHD grants for the paper: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (`maternal:nichd`)

## Provenance

Content hash: 2b7b23d963e9fbae89b15fa2350041417052c2e66158c90095f657526160a672
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14