Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study
- PMID: 30541506
- PMCID: PMC6292086
- DOI: 10.1186/s12884-018-2108-3
Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study
Abstract
Background: Annually in the US, over 100,000 pregnant women with overt type 2 diabetes give birth. Strict maternal glycemic control is the key to optimizing infant outcomes. Medical treatment of type 2 diabetes in pregnancy is generally restricted to insulin, as data on the safety and efficacy of oral hypoglycemic agents in pregnancy are limited. However, over one-third of infants born to women with type 2 diabetes experience an adverse outcome, such as premature delivery, large-for-gestational age, hypoglycemia, hyperbilirubinemia, or birth trauma, suggesting that current treatment regimens fall short of optimizing outcomes. Metformin is the pharmacologic treatment of choice for type 2 diabetes outside of pregnancy. Metformin is favored over insulin because it results in less weight gain, fewer hypoglycemic episodes, and is administered orally rather than injected. However, metformin is not typically used for treatment of type 2 diabetes complicating pregnancy, mainly because no large clinical studies have been conducted to examine its use in this context.
Methods/design: This is a randomized double-blind multi-center clinical trial of insulin plus metformin versus insulin plus placebo for the treatment of type 2 diabetes complicating pregnancy. A total of 1200 women with type 2 diabetes will be randomized between 10 weeks 0 days' and 20 weeks 6 days' gestation and followed until 30 days after delivery. Neonate outcomes will be followed until 30 days of age. The primary aim is to compare the effect of insulin and metformin versus insulin and placebo on composite adverse neonatal outcomes, comprising perinatal mortality, preterm delivery, neonatal hypoglycemia, hyperbilirubinemia, large-for-gestational age small for gestational age, low birth weight, and/or birth trauma. Key secondary aims are to compare treatment groups for neonatal fat mass and rate of maternal hypoglycemia. Additional aims are to assess the side effects and safety of insulin and metformin among pregnant women with overt type 2 diabetes and to compare gestational weight gain among women treated with metformin plus insulin versus insulin alone.
Discussion: Successful completion of this study will result in high-quality, contemporary evidence for management of overt type 2 diabetes complicating pregnancy to improve neonatal outcomes.
Trial registration: NCT02932475 (05/17/2016).
Keywords: Fetal outcomes; Maternal outcomes; Pregnancy; Type 2 diabetes.
Conflict of interest statement
Ethics approval and consent to participate
All study sites have obtained Institutional Review Board approval before the start of the study.
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (Study Number 15–3235); The Ohio State University at Columbus, Ohio (Study Number 2017H0088); University of Pennsylvania, Philadelphia, Pennsylvania (Study Number 826955); University of California, San Diego Maternal Fetal Care Services and the Medical Offices South Women’s Health Services, San Diego, California (Study Number 160660); University of Alabama-Birmingham, Birmingham, Alabama (Study Number 170307003); University of Utah Health Sciences Center, including the LDS Hospital, McKay-Dee Hospital Center, Utah Valley Regional Medical Center (Study Number 00098741), and the Intermountain Medical Center in Salt Lake City, Utah (Study Number 1050647); University of Texas Medical Branch, Galveston, Texas (Study Number 15–0240; University of Texas Memorial Hermann Hospital and the LBJ Hospital Houston, Houston, Texas (Study Number 17-06-1684); and Columbia University, New York, New York (Study Number AAAR2412).
Verbal and written consent will be obtained from all women interested in joining the study.
Women who meet the inclusion criteria at all of the sites are approached by the physician or nurse and the study is explained. The risks and benefits of participating are reviewed. Joining the study is voluntary and they can stop at any time. Refusing to join the study or stopping the study will not affect their care. After all questions are answered the woman is asked to sign the consent. She is given a copy of the consent. If she has concerns at any time she is encouraged to contact the office where she receives care.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
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