The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
The EAGER pilot trial is designed to assess the feasibility of a Canadian, multicentre prospective randomized open-label blinded end-point (PROBE) clinical trial addressing whether induction of labour (IOL) at 38 weeks' gestation compared to expectant management (EM) reduces severe perinatal mortality and morbidity among individuals with gestational diabetes mellitus (GDM). Eligible participants will be consented between 32 weeks + 0 days and 38 weeks + 0 days gestation and randomized between 36 weeks + 0 days and 38 weeks + 0 days gestation. Participants will be randomized to one of two arms:
- Intervention Arm: IOL between 38 weeks + 0 days and 38 weeks + 6 days OR
- Control Arm: EM without intervention until spontaneous labour, or earlier if a medical indication arises.
A total of 260 participants (130 per group) will be recruited from Canadian sites, where participants will have 3 study visits:
- Enrollment and randomization
- After delivery and up to 72 hours postpartum
- 6 weeks postpartum At enrollment and randomization, patient-reported baseline and clinical data from medical charts will be collected. Upon admission to hospital for labour and delivery, a blood sample may be collected to assess HbA1C and plasma glucose levels. After delivery and up to 72 hours postpartum, study feasibility will be assessed through patient-reported outcomes and administrative and clinical data. At 6 weeks postpartum, participants will be surveyed for secondary health resource use. Findings from this pilot will inform the design, implementation and feasibility of a future full-scale randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GDM after 24 weeks of gestation, based on documented 1-step or 2-step screening and diagnostic tests for GDM.
- •Singleton fetus at randomization.
- •Confirmed live fetus within 24 hours prior to randomization.
- •Gestational age between 36 weeks + 0 days and 38 weeks + 0 days inclusive based on an ultrasound in the first or second trimester [≤ 23 weeks + 0 days]. For pregnancies conceived by in vitro fertilization, dating will be based on the embryo age at transfer.
- •Cephalic presentation.
- •Planning to deliver at a participating site.
- •Aged 16 years or older.
排除标准
- •Pre-pregnancy diabetes mellitus.
- •Any obstetrical/maternal indication for immediate delivery including placenta abruption, abnormal fetal well-being either by non-stress test or biophysical profile, history of venous thromboembolism (VTE) on low molecular weight heparin, pre-existing hypertension, gestational hypertension, preeclampsia, eclampsia, or Hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome at the time of randomization.
- •Contraindication to labour and/or vaginal delivery.
- •Signs of labour (regular uterine contractions accompanied by cervical dilation and/or effacement) at the time of randomization.
- •Significant vaginal bleeding or ruptured membranes at the time of randomization.
- •Prior Cesarean delivery.
- •Placenta previa, placenta accreta, or vasa previa.
- •Cerclage in current pregnancy.
- •Known major fetal anomaly (e.g., gastroschisis, congenital heart defects).
- •Known oligohydramnios (AFI < 5 or MVP < 2 or no 2 by 2 pocket).
- •Known fetal growth restriction (EFW < 3rd percentile).
- •Refusal of blood products.
- •Use of unregulated substances.
结局指标
主要结局
Participant Recruitment Rate
时间窗: Within 24 months of randomizing the first participant
The pilot trial will be considered feasible if least 75% of the target sample can be recruited after 24 months of recruitment. The number of screened, approached, consented and randomized individuals will be recorded to assess feasibility. Recruitment rate will be measured by the proportion of eligible participants enrolled (consented and randomized) into the study.
次要结局
- Appropriateness of eligibility criteria(Within 24 months of randomizing the first participant)
- Participant retention(Within 24 months of randomizing the first participant)
- Non-compliance(Within 24 months of randomizing the first participant)
- Participant satisfaction(Within 24 months of randomizing the first participant)
- Suitability of maternal and neonatal clinical endpoints.(Within 24 months of randomizing the first participant)