Effect of Fiber Supplementation on the Need for Medication with Gestational Diabetes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Number of Participants with Need for GDM Medication
研究概览
简要总结
The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.
详细描述
The study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as GDMA1). The participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. The participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestation
- •Known or new diagnosis of gestational diabetes without reason for medication
- •Age >=18 to <=50
排除标准
- •- Non-English as primary language.
- •Known or suspected fetal anomaly or aneuploidy.
- •Known lower bowel disorder
- •Known phenylketonuria
- •Prisoners.
- •Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.
结局指标
主要结局
Number of Participants with Need for GDM Medication
时间窗: From date of randomization until the date of first documented progression (assessed up to 7 months)
The primary outcome is the need for medication (either insulin or oral hypoglycemic agents) for management of gestational diabetes (progression from GDMA1 to GDMA2). We chose this primary outcome because the need for medication is associated with the need for significantly more antenatal interventions due to increased adverse pregnancy outcomes.
次要结局
- Hgb A1c at delivery(At delivery)
- Rate of Fetal Demise(From date of randomization until the date of documented occurrence (assessed up to 7 months))
- Number of Participants Diagnosed with Fetal Growth Restriction(From date of randomization until the date of first documented progression (assessed up to 7 months))
- Number of Participants Diagnosed with Preeclampsia(From date of randomization until the date of first documented progression (assessed up to 7 months))
- Number of Participants with Placental Abruption(From date of randomization until the date of first documented progression (assessed up to 7 months))
- Quantitative Blood Loss(At delivery)
- Mode of Delivery(At delivery)
- Indication for Cesarean Delivery(At delivery)
- Rate of Postpartum Hemorrhage(At delivery)
- Rate of Shoulder Dystocia(At delivery)
- Rates of Infection(Delivery until discharge (assessed up to 5 days))
- Birth Weight(At delivery)
- Apgar Score(At delivery)
- Rates of Neonatal Infections(Delivery until discharge (assessed up to 5 days))
- Rate of Respiratory Distress Syndrome(At delivery)
- Rate of Necrotizing Enterocolitis(Delivery until discharge (assessed up to 5 days))
- Rate of NICU Admission(Delivery until discharge (assessed up to 5 days))
- Days in NICU(Delivery until discharge of the neonate (assessed up to 180 days))
研究者
Jerri Waller
Principal Investigator
Eastern Virginia Medical School