Prediabetes; Complicating Pregnancy
Conditions
Keywords
maternal outcomes, neonatal outcomes, metformin, prediabetes, pregnancy
Brief summary
The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.
Detailed description
Women in pregnancy are routinely screened for diabetes in the first trimester and those who fall into the prediabetes category by hemoglobin A1c level of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation will be approached for consent in our randomized trial. Once consent is obtained, the subjects will be randomized 1:1 into two parallel groups, the metformin treatment group and the standard of care treatment group (routine prenatal care). A random number generator will allocate the participants to the study groups. Women taking metformin will continue twice daily dosing for the duration of their pregnancy after randomization. Those in the standard of care group will receive routine prenatal care. Both groups will undergo routine gestational diabetes testing by 28 weeks. Obstetric, maternal, and neonatal outcomes will then be assessed of both groups until the 6 week postpartum visit.
Interventions
DRUGMetformin
Maximum dosage of 500 mg tablets 2 times a day (with each meal)
Sponsors
Gianna Wilkie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
Intervention model description
This is a prospective, single center, randomized study evaluating metformin in the treatment of pregnant women with prediabetes on maternal and neonatal outcomes.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation * Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center * Patients able to provide written informed consent
Exclusion criteria
* Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above * Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin * Participants who are under the age of 18 * Multiple Pregnancy * Patients already taking metformin for other indications * Fetal defect noted on early dating ultrasound * Miscarriage before randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth Weight | At Birth | Used to determine large for gestational age status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Cooling | Within first 2 days of life | Need for neonatal cooling within first 48 hours of life |
| Umbilical Cord Blood Level of C-peptide | At Birth | — |
| Umbilical Cord Blood Level of Leptin | At Birth | — |
| Umbilical Cord Blood Level of Insulin | At Birth | — |
| Placental Pathology | At Birth | Assessing for malperfusion pathology |
| Number of Participants with Postpartum Hemorrhage | At Delivery | Estimated or quantitative blood loss greater than 1000 mL |
| Number of Participants with Neonatal Hyperbilirubinemia | Within first 2 days of life | Requiring phototherapy |
| Number of Participants requiring Neonatal Intubation | At Delivery | — |
| Number of Participants with Development of Pregnancy Induced Hypertension | Through study completion, starting at 14 weeks until delivery | Blood pressure, serum laboratory analysis, and urine protein would be assessed for diagnosis |
| Number of Participants needing Cesarean Section | At Delivery | Number of Participants with Cesarean Section |
| Maternal Weight Gain in Pregnancy | At enrollment and last prenatal visit, starting at 14 weeks until delivery | — |
| Pregnancy Outcome | Through study completion, starting at 14 weeks until delivery | Number of Participants with Stillbirth, livebirth, pregnancy loss |
| Number of Participants with Preterm birth | At delivery | Less than 37 week delivery |
| Neonatal Intensive Care Unit Admission | At delivery and within first 2 days of life | Admission to level 2 or greater neonatal ICU and length of stay |
| Apgar Score at Birth | At delivery | \<6 at 1 and 5 minutes |
| Number of Participants with Neonatal Birth Trauma | At Delivery | Brachial plexus injury |
| Number of Participants with Shoulder Dystocia | At Delivery | — |
| Number of Participants with Neonatal Hypoglycemia | Within first 2 days of life | — |
| Number of Participants with Neonatal Respiratory Distress | At Delivery | Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis |
| Development of Gestational Diabetes | Assessed at 28 weeks of pregnancy | A glucose tolerance test would be conducted at 28 weeks of pregnancy to diagnose diabetes |
Countries
United States
Outcome results
None listed