Randomized Controlled Trial

. 2015 Oct;213(4):560.e1-8.

doi: 10.1016/j.ajog.2015.06.022. Epub 2015 Jun 11.

Timing of treatment initiation for mild gestational diabetes mellitus and perinatal outcomes

Anna Palatnik¹, Lisa Mele², Mark B Landon³, Uma M Reddy⁴, Susan M Ramin⁵, Marshall W Carpenter⁶, Ronald J Wapner⁷, Michael W Varner⁸, Dwight J Rouse⁹, John M Thorp Jr¹⁰, Anthony Sciscione¹¹, Patrick Catalano¹², George R Saade¹³, Steve N Caritis¹⁴, Yoram Sorokin¹⁵; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network

Collaborators, Affiliations

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network:
A Peaceman, P Simon, G Mallett, B Casey, K Leveno, L Moseley, J Gold, D Bradford, L Fay, M Garcia, F Capellan, M Miodovnik, F Malone, S Bousleiman, H Husami, V Carmona, N Fredericks, E Gantioqui, B Greenspan, M Williams, K Anderson, P Ashby, S McAllister, S Quinn, F Castinella, A Guzman, J Steiner, J Parker, J Sheppard, J Tisdale, A Northen, W Andrews, D Catlow, D Allard, M Seebeck, J Tillinghast, J Iams, F Johnson, C Latimer, E Weinandy, B Maselli, K Dorman, S Brody, S Timlin, J Bernhardt, M Hoffman, E Guzman, M Talucci, T Grossman, C Perez, L Zeghibe, P Tabangin, B Mercer, B Stetzer, C Milluzzi, W Dalton, S Pichette, M Harper, M Swain, P Meis, J White, L Gilstrap, K Cannon, J Martinez, D Dusek, J Moss, J Brandon, A Jackson, G Hankins, D Sharp, M Bickus, H Birkland, M Cotroneo, N Cuddy, G Norman, P Lockhart, S Blackwell, L Quast, A Peaceman, P Simon, G Mallett, J Tolosa, L Davis, E Lairson, C Cromett, C Naze, M Blaser, E Thom, J Zachary, B Getachew, C Cobb, L Leuchtenburg, S Gilbert, T Spangler, C Spong, S Tolivaisa, K Howell, G D Anderson

Affiliations

¹ Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL. Electronic address: anna.palatnik@northwestern.edu.
² George Washington University Biostatistics Center, Washington, DC.
³ Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH.
⁴ Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
⁵ Department of Obstetrics and Gynecology, The University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, TX.
⁶ Department of Obstetrics and Gynecology, Alpert Medical School, Brown University, Providence, RI.
⁷ Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY.
⁸ Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, UT.
⁹ Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL.
¹⁰ Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.
¹¹ Department of Obstetrics and Gynecology, Drexel University School of Medicine, Philadelphia, PA.
¹² Department of Obstetrics and Gynecology, Case Western Reserve University-MetroHealth Medical Center, Cleveland, OH.
¹³ Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX.
¹⁴ Department of Obstetrics and Gynecology, University of Pittsburgh School of Medicine, Pittsburgh, PA.
¹⁵ Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI.

PMID: 26071920
PMCID: PMC4609640
DOI: 10.1016/j.ajog.2015.06.022

Randomized Controlled Trial

Timing of treatment initiation for mild gestational diabetes mellitus and perinatal outcomes

Anna Palatnik et al. Am J Obstet Gynecol. 2015 Oct.

. 2015 Oct;213(4):560.e1-8.

doi: 10.1016/j.ajog.2015.06.022. Epub 2015 Jun 11.

Authors

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network:
A Peaceman, P Simon, G Mallett, B Casey, K Leveno, L Moseley, J Gold, D Bradford, L Fay, M Garcia, F Capellan, M Miodovnik, F Malone, S Bousleiman, H Husami, V Carmona, N Fredericks, E Gantioqui, B Greenspan, M Williams, K Anderson, P Ashby, S McAllister, S Quinn, F Castinella, A Guzman, J Steiner, J Parker, J Sheppard, J Tisdale, A Northen, W Andrews, D Catlow, D Allard, M Seebeck, J Tillinghast, J Iams, F Johnson, C Latimer, E Weinandy, B Maselli, K Dorman, S Brody, S Timlin, J Bernhardt, M Hoffman, E Guzman, M Talucci, T Grossman, C Perez, L Zeghibe, P Tabangin, B Mercer, B Stetzer, C Milluzzi, W Dalton, S Pichette, M Harper, M Swain, P Meis, J White, L Gilstrap, K Cannon, J Martinez, D Dusek, J Moss, J Brandon, A Jackson, G Hankins, D Sharp, M Bickus, H Birkland, M Cotroneo, N Cuddy, G Norman, P Lockhart, S Blackwell, L Quast, A Peaceman, P Simon, G Mallett, J Tolosa, L Davis, E Lairson, C Cromett, C Naze, M Blaser, E Thom, J Zachary, B Getachew, C Cobb, L Leuchtenburg, S Gilbert, T Spangler, C Spong, S Tolivaisa, K Howell, G D Anderson

Affiliations

¹ Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL. Electronic address: anna.palatnik@northwestern.edu.
² George Washington University Biostatistics Center, Washington, DC.
³ Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH.
⁴ Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
⁵ Department of Obstetrics and Gynecology, The University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, TX.
⁶ Department of Obstetrics and Gynecology, Alpert Medical School, Brown University, Providence, RI.
⁷ Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY.
⁸ Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, UT.
⁹ Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL.
¹⁰ Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.
¹¹ Department of Obstetrics and Gynecology, Drexel University School of Medicine, Philadelphia, PA.
¹² Department of Obstetrics and Gynecology, Case Western Reserve University-MetroHealth Medical Center, Cleveland, OH.
¹³ Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX.
¹⁴ Department of Obstetrics and Gynecology, University of Pittsburgh School of Medicine, Pittsburgh, PA.
¹⁵ Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI.

PMID: 26071920
PMCID: PMC4609640
DOI: 10.1016/j.ajog.2015.06.022

Abstract

Objective: The purpose of this study was to examine the association between gestational age (GA) at the time of treatment initiation for gestational diabetes mellitus (GDM) and maternal and perinatal outcomes.

Study design: We conducted a secondary analysis of a multicenter randomized treatment trial of mild GDM in which women with mild GDM were assigned randomly to treatment vs usual care. The primary outcome of the original trial, as well as this analysis, was a composite perinatal adverse outcome that included neonatal hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and perinatal death. Other outcomes that were examined included the frequency of large for GA, birthweight, neonatal intensive care unit admission, gestational hypertension/preeclampsia, and cesarean delivery. The interaction between GA at treatment initiation (stratified as 24-26, 27, 28, 29, and ≥30 weeks of gestation) and treatment group (treated vs routine care), with the outcomes of interest, was used to determine whether GA at treatment initiation was associated with outcome differences.

Results: Of 958 women whose cases were analyzed, those who initiated treatment at an earlier GA did not gain an additional treatment benefit compared with those who initiated treatment at a later GA (probability value for interaction with the primary outcome, .44). Similarly, there was no evidence that other outcomes were improved significantly by earlier initiation of GDM treatment (large for GA, P = .76; neonatal intensive care unit admission, P = .8; cesarean delivery, P = .82). The only outcome that had a significant interaction between GA and treatment was gestational hypertension/preeclampsia (P = .04), although there was not a clear cut GA trend where this outcome improved with treatment.

Conclusion: Earlier initiation of treatment of mild GDM was not associated with stronger effect of treatment on perinatal outcomes.

Keywords: gestational age; gestational diabetes mellitus; outcome.

PubMed Disclaimer

Conflict of interest statement

Disclosures: The authors report no conflict of interest.

Figures

**Figure 1. Screening, enrollement and random assignment to study group**
GCT- glucose tolerance test OGTT- oral glucose tolerance test

**Figure 2**
Plost for Odds ratio and 95% Confidence Intervals for treatment versus control group by gestational age at rendomization for the outcomes of interest.

See this image and copyright information in PMC

References

1. Metzger BE, Lowe LP, Dyer AR, et al. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358:1991–2002. - PubMed
1. Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005;352:2477–86. - PubMed
1. Landon MB, Spong CY, Thom E, et al. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339–48. - PMC - PubMed
1. ACOG Practice Bulletin No. 137: Gestational diabetes mellitus. Obstet Gynecol. 2013;122:406–16. - PubMed
1. National Institutes of Health consensus development conference statement: diagnosing gestational diabetes mellitus, March 4-6, 2013. Obstet Gynecol. 2013;122:358–69. - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Grants and funding

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- ClinicalTrials.gov

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Timing of treatment initiation for mild gestational diabetes mellitus and perinatal outcomes

Collaborators

Affiliations

Timing of treatment initiation for mild gestational diabetes mellitus and perinatal outcomes

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical