Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Birth Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Metformin
Study subjects will be randomized to the metformin medication arm. They will take a 500 mg tablet orally twice a day starting at 14 weeks of pregnancy until delivery.
干预措施: Metformin (Drug)
结局指标
主要结局
Birth Weight
时间窗: At Birth
Used to determine large for gestational age status
次要结局
- Number of Participants needing Cesarean Section(At Delivery)
- Pregnancy Outcome(Through study completion, starting at 14 weeks until delivery)
- Neonatal Cooling(Within first 2 days of life)
- Umbilical Cord Blood Level of Leptin(At Birth)
- Placental Pathology(At Birth)
- Development of Gestational Diabetes(Assessed at 28 weeks of pregnancy)
- Number of Participants with Preterm birth(At delivery)
- Number of Participants with Neonatal Hypoglycemia(Within first 2 days of life)
- Number of Participants requiring Neonatal Intubation(At Delivery)
- Apgar Score at Birth(At delivery)
- Umbilical Cord Blood Level of C-peptide(At Birth)
- Umbilical Cord Blood Level of Insulin(At Birth)
- Number of Participants with Development of Pregnancy Induced Hypertension(Through study completion, starting at 14 weeks until delivery)
- Neonatal Intensive Care Unit Admission(At delivery and within first 2 days of life)
- Number of Participants with Neonatal Hyperbilirubinemia(Within first 2 days of life)
- Number of Participants with Postpartum Hemorrhage(At Delivery)
- Maternal Weight Gain in Pregnancy(At enrollment and last prenatal visit, starting at 14 weeks until delivery)
- Number of Participants with Neonatal Birth Trauma(At Delivery)
- Number of Participants with Shoulder Dystocia(At Delivery)
- Number of Participants with Neonatal Respiratory Distress(At Delivery)
研究者
Gianna Wilkie
Principal Investigator
University of Massachusetts, Worcester